<h3>Job Description</h3>
Job Description
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?&nbsp;MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit <a href="http://www.mmsholdings.com&nbsp;or" target="_blank">www.mmsholdings.com&nbsp;or</a> follow MMS on LinkedIn.
Responsibilities:
<ul>
<li>Interact with clients and regulatory authorities, remotely and onsite, including representation at key regulatory meetings on behalf of the client.</li>
<li>Demonstrated ability to lead/ manage multiple individuals and/or groups.</li>
<li>Cross-functionally collaborates and coordinates Transparency deliverables ensuring that timelines and milestones remain on-track and within target.</li>
<li>Strategically assesses resource utilization and forecasting to ensure companywide goals are met</li>
<li>Effectively communicates complex strategic concepts with ability to tailor message to targeted audience.</li>
<li>Demonstrate thought leadership with customers by developing and presenting client industry trends, benchmarking, and other pertinent information. May participate in industry events for this purpose.</li>
<li>Demonstrated ability to lead / manage multiple individuals and/or groups in a global environment.</li>
<li>Directs strategic planning and proactively prepares contingency plans to address unforeseen challenges within group, and cross functionally to ensure uninterrupted delivery and maintain compliance.</li>
<li>Ability to facilitate positive group morale and productivity by appropriately including others in decisions/plans.</li>
<li>Manages staff, makes decisions and advises others on complex problems; understands intra- and inter-departmental implications of decisions and can develop strategic solutions with minimal input.</li>
<li>Direct, manage, and oversee the daily activities and workload of the transparency, PLS, and redaction teams.</li>
<li>Proactively identifies areas for improvement before issues arise and provides strategic proposal/resolution for consideration.</li>
<li>Develops and leads teams with diverse experience and skill sets to achieve intra and inter departmental goals.&nbsp;</li>
</ul>
Requirements:&nbsp;
<ul>
<li>Graduate degree in scientific, medical, clinical discipline or related field, or related experience, Masters preferred.</li>
<li>Minimum of 6 years’ experience in clinical trial transparency, disclosure, or medical writing role</li>
<li>At least 5 years of experience in a CRO environment.</li>
<li>Demonstrated managerial skills and experience preferred.</li>
<li>High level knowledge of drug development process, clinical development, and operations, with a strong understanding of regulatory guidelines.</li>
<li>Excellent scientific writing skills.</li>
<li>Excellent analytical, organizational, and problem-solving skills.</li>
<li>Proficiency with MS Office applications.</li>
<li>Strong communication and presentation skills.</li>
<li>Knowledge of ISO 9001, ISO 27001, 21 CFR Part 11, FDA, and GCP requirements</li>
<li>Understanding of CROs and scientific &amp; clinical data/ terminology, &amp; the drug development process.</li>
</ul>
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2vzTw7PPAe

Senior Manager, Clinical Trial Transparency & Disclosure (Remote)

<h3>Job Description</h3>
Job DescriptionSalary: $72,000 - $88,000 
We are looking for a Clinical Trial Manager II to join our team!
Are you well organized and adaptable to unexpected changes? Someone who is able to see the bigger picture, without losing sight of the day-to-day tasks? If the answer is yes, keep reading!
Clinical Trial Manager II serves as the primary point of contact for clinical trials site operations.
 
Remote candidates are welcome to apply.
In this position you will:
<ul>
<li>Serve as the secondary contact to address site questions when the site Clinical Research Associate (CRA) or Research Assistant (RA) is unavailable.</li>
<li>Ensure CPC SOPs, Good Clinical Practice guidelines and applicable federal, state and local regulations are being followed.</li>
<li>Review monitoring visit reports and follow-up letters for Site Endpoint Evaluation Visits, Site Evaluation Visits, Site Initiation Visits, Routine Monitoring Visits, and Close-out Visits and Addendums and work with CRAs to clarify issues and finalize reports and follow-up letters.</li>
<li>Review site specific Informed Consent Forms (ICFs) to address site specific changes and escalate to internal or external parties for approval, as needed.</li>
<li>Provide the Project Manager with metrics and updates on sites including but not limited to: study related site enrollment, site activations, protocol deviations, monitoring reports and follow-up letters status.</li>
<li>Assure proper maintenance of site required records for monitoring activities and required regulatory documents per CPC requirements.</li>
<li>Create and/or review study-specific monitoring visit reports and, follow-up letter templates, and project specific site materials including Monitoring Plans, ICF templates, Study Procedure Manual, source document and site newsletter.</li>
<li>Work with CRAs, RAs and new Clinical Trial Managers on overall site management including identification, escalation and resolution of site related compliance issues.</li>
<li>Oversee Investigational Product (IP) release and once IP release has occurred, work with the RAs to collect all new or expiring Investigator regulatory documents.</li>
<li>Oversee and approve site activations and IP release.</li>
<li>Participate in project-related and other departmental/CPC meetings as required.</li>
<li>Oversee the selection of qualified sites and Investigators for participation in research protocols.</li>
<li>Work with sites to negotiate the study site budget. Oversee tracking, request and work with the Finance department on processing study site payments.</li>
<li>Oversee project specific training of site staff.</li>
<li>Train new Clinical Trial Managers on reviewing and processing monitoring visit reports and follow-up letters, completing metrics and updates, tracking site specific documents, and creating project specific documents.</li>
<li>Attend project team meetings as necessary and provide CRAs with updated study information to support their monitoring and SEEV activities.</li>
<li>Work closely with other team members to ensure timely resolution of site issues.</li>
<li>Conduct drug tracking and disposition as required by project.</li>
<li>Overseeing remote monitoring.</li>
<li>Ensure Clinical Trial Management System (CTMS) remains up to date with all site trial activities including but not limited to site communications, document status, monitoring visits, protocol deviations.</li>
<li>Conduct site monitoring visits or co-monitoring visits, as needed.</li>
</ul>
Heres what you will need to bring to the table:
<ul>
<li>Nursing or bachelors degree preferred.</li>
<li>A minimum of 3 years of experience in clinical research setting required.</li>
<li>Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials.</li>
<li>Thorough understanding of the drug development process.</li>
<li>Proficiency in Microsoft Office Suite (Excel, Word, Outlook, PowerPoint).</li>
<li>Experience with electronic data capture systems.</li>
<li>Excellent interpersonal communication skills, organizational skills and a great attention to detail. Ability to organize and instruct staff, while promoting group effort and achievement.</li>
<li>Ability to carry out multiple tasks simultaneously.</li>
<li>Ability to complete tasks in an accurate and timely manner.</li>
<li>Ability to manage conflicts and resolve problems effectively.</li>
<li>Ability to discern priorities with minimal direction to accomplish day-to-day tasks.</li>
<li>Willingness to travel up to 25% of the time.</li>
</ul>
Note:Viable applicants will be required to pass a background and education verification check.
Targeted Compensation:$72,000 - $88,000 annually
 
Deadline to Apply: June 1, 2025
 
About CPC:
 
CPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 30 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more. 
CPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials.
CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. <a href="http://www.cpccommunityhealth.org/" target="_blank">http://www.cpccommunityhealth.org/</a>
CPC offers:
<ul>
<li>Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)</li>
<li>Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)</li>
<li>11 paid holidays</li>
<li>15 - 25 vacation days based on years of service</li>
<li>Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours)</li>
<li>In-suite exercise and relaxation room</li>
<li>Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)</li>
<li>Flexible and remote work schedules</li>
</ul>
An Equal Opportunity Employer
 
CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.
Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at <a href="mailto:careers@cpcmed.org" target="_blank">careers@cpcmed.org</a>.
 remote work

Clinical Trial Manager II

<h3>Job Description</h3>
Job DescriptionSalary: 
About Aura:
 
Aura Biosciences is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors that aim to preserve organ function. Our lead candidate, bel-sar (AU-011), is currently in late-stage development for primary choroidal melanoma and in early-stage development in other ocular oncology indications and bladder cancer. Aura Biosciences is headquartered in Boston, MA. Our mission is to grow as an innovative global oncology company that positively transforms the lives of patients.
 
For more information, visit aurabiosciences.com. Follow us on X (formerly Twitter) @AuraBiosciences and visit us on LinkedIn.
 
Roles &amp; Responsibilities:
The Sr. Clinical Trial Manager will provide clinical trial management support for ongoing and future clinical trials in our lead programs in ocular melanoma. Candidate will function as the Clinical Trial Lead on at least one trial that is managed either in-house by the Aura Clinical Team or in collaboration with a Contract Research Organization (CRO). Partnering closely with the cross-functional stakeholders (Clinical, Regulatory, Product Development), you will apply strong clinical and project management fundamentals for the implementation of various aspects of our clinical trials.
Essential functions:
<ul>
<li>Clinical Trial Manager will be responsible for managing and driving various aspects of clinical trial conduct with a cross-functional team of subject matter experts including Clinical Development, Biometrics, contracted Vendors, and Regulatory to achieve clinical trial goals on time and within budget. If the study is utilizing a CRO, managing and driving their activities and deliverables.</li>
<li>Develop and implement clinical processes and procedures including site budgets, investigator payments, protocol compliance reporting, risk assessments and investigational product and device management.</li>
<li>Develop and maintain clinical trial documents including but not limited to informed consent templates, study plans and manuals, newsletters and site communications.</li>
<li>Collaborate with Data Management Vendor to develop eCRF and completion guidelines as well as conduct user acceptance testing prior to release.</li>
<li>Oversee data entry timelines and query management, including metric reporting.</li>
<li>Oversee and conduct periodic clinical review of data entered into eCRF.</li>
<li>Provide oversight and management of regional Clinical Research Associates (CRAs) including review of site visit reports and training records.</li>
<li>Oversee investigative site and CRA adherence to SOPs, Good Clinical Practice and FDA regulations.</li>
<li>Manage the Trial Master File (TMF) and ensure contents are current and audit ready.</li>
<li>Manage study budget and finances within established tolerances.</li>
<li>Facilitate and manage productive team communication and collaboration, both internally and externally.</li>
</ul>
Qualifications:
<ul>
<li>The ideal candidate should have a minimum of a bachelors degree in the life sciences and 5-8 years of direct and progressive experience specific tobiopharma clinical trial management with a track record of successful management of complex programs using multiple external vendors. Experience in ophthalmology and/or oncology preferred.</li>
<li>Global clinical trial management strongly preferred</li>
<li>Candidates should have experience with Microsoft office programs and web-based data entry platforms.</li>
<li>Candidates should have a passion for learning, creating, relating, communicating, and helping drive the success of cross functional teams.</li>
</ul>
 
Salary &amp; Benefit Information: 
 
Salary Range: $140,000/yr - $185,000/yr
(Placement within the listed range depends on many factors including, but not limited to: geographic location, degree, years of experience, and internal company equity)
Health insurance with FULL premium coverage
401K with company match
Employee Stock Purchase Program (ESPP)
Competitive paid time off (PTO)
Company-paid short &amp; long-term disability insurance and life insurance
 remote work

Sr. Clinical Trial Manager- Ophthalmology

<h3>Job Description</h3>
Job DescriptionSalary: $72,000 - $88,000 
We are looking for a Clinical Trial Manager II to join our team!
Are you well organized and adaptable to unexpected changes? Someone who is able to see the bigger picture, without losing sight of the day-to-day tasks? If the answer is yes, keep reading!
Clinical Trial Manager II serves as the primary point of contact for clinical trials site operations.
 
Remote candidates are welcome to apply.
In this position you will:
<ul>
<li> Serve as the secondary contact to address site questions when the site Clinical Research Associate (CRA) or Research Assistant (RA) is unavailable. </li>
<li> Ensure CPC SOPs, Good Clinical Practice guidelines and applicable federal, state and local regulations are being followed.</li>
<li> Review monitoring visit reports and follow-up letters for Site Endpoint Evaluation Visits, Site Evaluation Visits, Site Initiation Visits, Routine Monitoring Visits, and Close-out Visits and Addendums and work with CRAs to clarify issues and finalize reports and follow-up letters.</li>
<li> Review site specific Informed Consent Forms (ICFs) to address site specific changes and escalate to internal or external parties for approval, as needed.</li>
<li> Provide the Project Manager with metrics and updates on sites including but not limited to: study related site enrollment, site activations, protocol deviations, monitoring reports and follow-up letters status.</li>
<li> Assure proper maintenance of site required records for monitoring activities and required regulatory documents per CPC requirements. </li>
<li> Create and/or review study-specific monitoring visit reports and, follow-up letter templates, and project specific site materials including Monitoring Plans, ICF templates, Study Procedure Manual, source document and site newsletter.</li>
<li> Work with CRAs, RAs and new Clinical Trial Managers on overall site management including identification, escalation and resolution of site related compliance issues. </li>
<li> Oversee Investigational Product (IP) release and once IP release has occurred, work with the RAs to collect all new or expiring Investigator regulatory documents.</li>
<li> Oversee and approve site activations and IP release. </li>
<li> Participate in project-related and other departmental/CPC meetings as required.</li>
<li> Oversee the selection of qualified sites and Investigators for participation in research protocols.</li>
<li> Work with sites to negotiate the study site budget. Oversee tracking, request and work with the Finance department on processing study site payments.</li>
<li> Oversee project specific training of site staff.</li>
<li> Train new Clinical Trial Managers on reviewing and processing monitoring visit reports and follow-up letters, completing metrics and updates, tracking site specific documents, and creating project specific documents.</li>
<li> Attend project team meetings as necessary and provide CRAs with updated study information to support their monitoring and SEEV activities.</li>
<li> Work closely with other team members to ensure timely resolution of site issues.</li>
<li> Conduct drug tracking and disposition as required by project. </li>
<li> Overseeing remote monitoring. </li>
<li> Ensure Clinical Trial Management System (CTMS) remains up to date with all site trial activities including but not limited to site communications, document status, monitoring visits, protocol deviations. </li>
<li> Conduct site monitoring visits or co-monitoring visits, as needed. </li>
</ul>
Heres what you will need to bring to the table:
 
<ul>
<li> Nursing or bachelors degree preferred.</li>
<li> A minimum of 3 years of experience in clinical research setting required.</li>
<li> Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials. </li>
<li> Thorough understanding of the drug development process.</li>
<li> Proficiency in Microsoft Office Suite (Excel, Word, Outlook, PowerPoint).</li>
<li> Experience with electronic data capture systems.</li>
<li> Excellent interpersonal communication skills, organizational skills and a great attention to detail. Ability to organize and instruct staff, while promoting group effort and achievement.</li>
<li> Ability to carry out multiple tasks simultaneously.</li>
<li> Ability to complete tasks in an accurate and timely manner.</li>
<li> Ability to manage conflicts and resolve problems effectively.</li>
<li> Ability to discern priorities with minimal direction to accomplish day-to-day tasks.</li>
<li> Willingness to travel up to 25% of the time. </li>
</ul>
Note:Viable applicants will be required to pass a background and education verification check.
Targeted Compensation:$72,000 - $88,000 annually
 
Deadline to Apply: May 1, 2025
 
About CPC:
 
CPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 30 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more. 
CPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials.
CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. <a href="http://www.cpccommunityhealth.org/" target="_blank">http://www.cpccommunityhealth.org/</a>
CPC offers:
 
<ul>
<li> Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)</li>
<li> Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)</li>
<li> 11 paid holidays</li>
<li>15 - 25 vacation days based on years of service</li>
<li>Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours)</li>
<li> In-suite exercise and relaxation room</li>
<li> Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)</li>
<li> Flexible and remote work schedules</li>
</ul>
An Equal Opportunity Employer
 
CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.
Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at <a href="mailto:careers@cpcmed.org" target="_blank">careers@cpcmed.org</a>.
 remote work

<h3>Job Description</h3>
Job DescriptionSalary: $72,000 - $88,000 
We are looking for a Clinical Trial Manager II to join our team!
Are you well organized and adaptable to unexpected changes? Someone who is able to see the bigger picture, without losing sight of the day-to-day tasks? If the answer is yes, keep reading!
Clinical Trial Manager II serves as the primary point of contact for clinical trials site operations.
 
Remote candidates are welcome to apply.
In this position you will:
<ul>
<li> Serve as the secondary contact to address site questions when the site Clinical Research Associate (CRA) or Research Assistant (RA) is unavailable. </li>
<li> Ensure CPC SOPs, Good Clinical Practice guidelines and applicable federal, state and local regulations are being followed.</li>
<li> Review monitoring visit reports and follow-up letters for Site Endpoint Evaluation Visits, Site Evaluation Visits, Site Initiation Visits, Routine Monitoring Visits, and Close-out Visits and Addendums and work with CRAs to clarify issues and finalize reports and follow-up letters.</li>
<li> Review site specific Informed Consent Forms (ICFs) to address site specific changes and escalate to internal or external parties for approval, as needed.</li>
<li> Provide the Project Manager with metrics and updates on sites including but not limited to: study related site enrollment, site activations, protocol deviations, monitoring reports and follow-up letters status.</li>
<li> Assure proper maintenance of site required records for monitoring activities and required regulatory documents per CPC requirements. </li>
<li> Create and/or review study-specific monitoring visit reports and, follow-up letter templates, and project specific site materials including Monitoring Plans, ICF templates, Study Procedure Manual, source document and site newsletter.</li>
<li> Work with CRAs, RAs and new Clinical Trial Managers on overall site management including identification, escalation and resolution of site related compliance issues. </li>
<li> Oversee Investigational Product (IP) release and once IP release has occurred, work with the RAs to collect all new or expiring Investigator regulatory documents.</li>
<li> Oversee and approve site activations and IP release. </li>
<li> Participate in project-related and other departmental/CPC meetings as required.</li>
<li> Oversee the selection of qualified sites and Investigators for participation in research protocols.</li>
<li> Work with sites to negotiate the study site budget. Oversee tracking, request and work with the Finance department on processing study site payments.</li>
<li> Oversee project specific training of site staff.</li>
<li> Train new Clinical Trial Managers on reviewing and processing monitoring visit reports and follow-up letters, completing metrics and updates, tracking site specific documents, and creating project specific documents.</li>
<li> Attend project team meetings as necessary and provide CRAs with updated study information to support their monitoring and SEEV activities.</li>
<li> Work closely with other team members to ensure timely resolution of site issues.</li>
<li> Conduct drug tracking and disposition as required by project. </li>
<li> Overseeing remote monitoring. </li>
<li> Ensure Clinical Trial Management System (CTMS) remains up to date with all site trial activities including but not limited to site communications, document status, monitoring visits, protocol deviations. </li>
<li> Conduct site monitoring visits or co-monitoring visits, as needed. </li>
</ul>
Heres what you will need to bring to the table:
 
<ul>
<li> Nursing or bachelors degree preferred.</li>
<li> A minimum of 3 years of experience in clinical research setting required.</li>
<li> Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials. </li>
<li> Thorough understanding of the drug development process.</li>
<li> Proficiency in Microsoft Office Suite (Excel, Word, Outlook, PowerPoint).</li>
<li> Experience with electronic data capture systems.</li>
<li> Excellent interpersonal communication skills, organizational skills and a great attention to detail. Ability to organize and instruct staff, while promoting group effort and achievement.</li>
<li> Ability to carry out multiple tasks simultaneously.</li>
<li> Ability to complete tasks in an accurate and timely manner.</li>
<li> Ability to manage conflicts and resolve problems effectively.</li>
<li> Ability to discern priorities with minimal direction to accomplish day-to-day tasks.</li>
<li> Willingness to travel up to 25% of the time. </li>
</ul>
Note:Viable applicants will be required to pass a background and education verification check.
Targeted Compensation:$72,000 - $88,000 annually
 
Deadline to Apply: April 1, 2025
 
About CPC:
 
CPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 30 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more. 
CPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials.
CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. <a href="http://www.cpccommunityhealth.org/" target="_blank">http://www.cpccommunityhealth.org/</a>
CPC offers:
 
<ul>
<li> Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)</li>
<li> Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)</li>
<li> 11 paid holidays</li>
<li>15 - 25 vacation days based on years of service</li>
<li>Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours)</li>
<li> In-suite exercise and relaxation room</li>
<li> Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)</li>
<li> Flexible and remote work schedules</li>
</ul>
An Equal Opportunity Employer
 
CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.
Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at <a href="mailto:careers@cpcmed.org" target="_blank">careers@cpcmed.org</a>.
 remote work

<h3>Job Description</h3>
Job Description
Clinical Trial Project Manager – BB14026
Remote
6+ Months
Remote (must be available for meetings between 7 AM–6 PM PT; one potential on-site workshop in Thousand Oaks in September) contract through till end of year.
The ideal candidate has at least 5 years of project or program management experience within the biotech or pharmaceutical industry. They possess strong organizational and communication skills, are confident navigating complex, matrixed environments, and can juggle multiple priorities under tight timelines. This individual should be familiar with clinical trial operations (experience with decentralized trials is a plus), and have a proven ability to manage stakeholders, vendors, budgets, and project plans. A bachelor’s degree is required, while an MBA or PMP certification is preferred but not mandatory. This is a high-visibility, fast-paced role with an urgent need to fill, supporting two enterprise-level initiatives, including a national patient-facing health platform. Candidates must be flexible with scheduling across time zones and able to attend one on-site workshop in Thousand Oaks in September.
Seeking an experienced project manager to support key, high profile, fast paced, complex Digital Medicine programs and projects, including the Decentralized Clinical Trials project and The PARC program.
Primary Projects Supported
Decentralized Clinical Trials (DCT)
Highly visible project (1 level down from the CEO), Includes six workstreams
Responsibilities: Meeting scheduling &amp; facilitation Agenda creation, risk identification, change management Cross-workstream coordination Functional reporting to another colleague (Soona)
The PARC Website (Patient-facing Cardiovascular Site), External-facing public health site
Responsibilities: Traditional PM tasks (minutes, scheduling, risk tracking) Budget and vendor management Liaison role between internal strategy owners and external vendor
Basic Qualifications
Doctorate degree or Master’s degree and 2 years of experience or Bachelor’s degree and 4 years of experience or Associate’s degree and 8 years of experience or High school diploma / GED and 10 years of experience
Top 3 Must Have Skill Sets:
Project Management Program Management Communication Skills
Day to Day Responsibilities:
Decentralized Clinical Trials Project (75% time for 8-12 months) Program Planning &amp; Coordination
<ul>
<li>Continue project and workstream startup activities including evolving workstream chartering and scoping, stakeholder identification, and project and workstream RACI development</li>
<li>Support the end-to-end project lifecycle for defining processes and programs for Client decentralized and pragmatic trials methodologies</li>
<li>Develop detailed project plan, timelines and milestones for overall project and workstreams aligned with project objectives</li>
<li>Act as thought partner to task force leads to help identify relationships and synergies in activities of the workstreams</li>
<li>Operational Execution</li>
<li>Coordinate cross-functional meetings and decision-making across multiple functions; manage meetings including developing agendas, meeting facilitation and follow up/actions tracking</li>
</ul>
<ul>
<li>Manage external vendors for timely, budget-compliant delivery</li>
<li>Define and report success measures, workstream metrics management and reporting</li>
<li>Track lessons learned and debrief with task force workstream leads at project close</li>
<li>SOW and budgetary management</li>
</ul>
Risk &amp; Issue ManagementCommunication &amp; DocumentationThe PARC Program (25% time for 8-12 months)Project management1. Manage projects using proven PM tools and techniques for the operational aspects of the program2. Support program lead with all operational and PM activities3. Mange meetings including setting agendas, scheduling meetings, taking notes and action items and ensuring actions are completed/resolved.4. Identify and mitigate/resolve risks and issues5. Track timelines6. Report program milestones and achievementsTechnology team partnership1. Help ensure technology workplans are clear and concise and translatable to the business2. Participate in Client platform buildout sessions3. Partner with technology representative to track and report accomplishments, milestones and mitigate/resolve risks and issues.MAC process1. Own and execute the legal, medical and regulatory (LMR) process to manage cross-business unit material submissions and approvals.2. Be trained and versed in MAC processes3. Provide materials to relevant compliance, legal, regulatory and privacy points of contact for feedback prior to submitting to MAC4. Work with LMR staff to ensure jobs are submitted properlySOW development, financial and budget management1. Work with all vendors and program leads to ensure SOWs are properly written and executed2. Track all budget-related items for The PARC and report spending to function operations director3. Process and approve invoicesVendor Management (platform vendor)1. Translate business needs from Client’s PARC team into action items for the vendor to act on including completing project request forms, obtaining quotes to open POs, coordinating review and approval by the vendor and Client teams2. Develop SOWs, track and manage budgets3. Metrics and reportinga. Monitor weekly vendor dashboardsb. Report operational milestones and achievements4. Partner with vendor PM fora. Risk and issue identification and resolutionb. Timeline tracking
<ul>
<li>Identify and mitigate project risks related to regulatory, operational, and technical challenges</li>
<li>Drive issue resolution and track actions to closure</li>
<li>Partner with task force and workstream leads to develop and cascade information among the workstreams and to stakeholders</li>
<li>Prepare executive updates, summaries, dashboards, and report-outs</li>
</ul>
TechData is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status
Company Description<a href="http://www.techdataservice.com" target="_blank">www.techdataservice.com</a> 
<h3>Company Description</h3>
<a href="http://www.techdataservice.com" target="_blank">www.techdataservice.com</a>

Clinical Trial Project Manager - BB14026

<h3>Job Description</h3>
Principal Clinical Trial Coordinator\n \n \nKelly® Science &amp; Clinical&nbsp;is hiring a contract Principal Clinical Trial Coordinator for one of our global CRO clients. This is a full-time, work from home contract opportunity with potential to extend. If you are passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust&nbsp;The Experts at Hiring Experts. \n&nbsp;\n
<ul>\n\t
<li>Location: This position is fully remote\n\t</li>
<li>Contract Length: 6+ months with potential to extend\n\t</li>
<li>Hours: Monday through Friday 8:30am-5:30pm ET\n\t</li>
<li>Pay: Hourly W-2, $42.96 - $47.73\n</li>
</ul>
\n \nSummarized Purpose: \nProvides administrative and technical support to the Project Team as a study lead, acting as a cross functional liaison. Coordinates and facilitates project activities and oversees administration on assigned projects. Acts as support during the onboarding phase. Provides training to new staff and identifies new training requirements. Supports creation, implementation and change management for departmental and cross-functional process improvement/enhancement initiatives. Aids the development of the critical path for site activation within assigned projects in support of rapid site activation. Serves as a point of escalation for project teams. \n \nEssential Functions:\n\n
<ul>\n\t
<li>According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial activities as detailed on the task matrix.\n\t</li>
<li>Uses critical thinking to ensure tasks are proactively scheduled and fulfilled in line with project team needs.\n\t</li>
<li>Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system(s).\n\t</li>
<li>Ensures allocated tasks are performed on time, within budget and to a high-quality standard.\n\t</li>
<li>Proactively communicates any risks to project leads and line manager as appropriate.\n\t</li>
<li>Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers, including, but not limited to, study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients, and tracking of project level activity plans in appropriate system(s). Ensures (e)TMF is up to date by following file review schedules and documents findings in appropriate system(s).\n\t</li>
<li>Supports RBM activities.\n\t</li>
<li>Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.\n\t</li>
<li>Supports scheduling and organization of client and/or internal meetings with completion of related meeting minutes.\n\t</li>
<li>Reviews and tracks local regulatory documents. Supports project team to ensure audit readiness, (i.e. (e)TMF) and contributes to internal, regulatory and client audit responses as needed.\n\t</li>
<li>Transmits documents to clients and centralized IRB/IEC.\n\t</li>
<li>Analyzes and reconciles study metrics and findings reports.\n\t</li>
<li>Assists with clarification and resolution of findings related to site documentation.\n\t</li>
<li>Maintains vendor trackers.\n\t</li>
<li>Assists with coordination, compilation, and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.\n\t</li>
<li>Assists with study-specific translation materials and translation QC upon request.\n\t</li>
<li>Provides system support (i.e., Activate &amp; eTMF) and ensures system databases are always current.\n\t</li>
<li>Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.\n\t</li>
<li>Liaises locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy.\n\t</li>
<li>Ensures that trial status information relating to activities are accurately maintained in the database and is always current.\n\t</li>
<li>Where applicable, develops and maintains relationship with client local affiliates.\n\t</li>
<li>Champions the inclusion of Strategic Collaboration sites into the process.\n\t</li>
<li>Where applicable, conduct on-site feasibility visits (Asia Pac only).\n\t</li>
<li>Train new personnel on processes and systems.\n\t</li>
<li>Contributes to discussions with teammates in other regions to support a collaborative network with consistent processes and sharing of best practices.\n\t</li>
<li>Expands therapeutic knowledge and expertise.\n\t</li>
<li>Attends Kick off Meeting and take notes, when required.\n\t</li>
<li>Provides training to other functional team members, Investigators and/or clients as requested.\n\t</li>
<li>Serves as an alliance-level lead, handling client integration and (e)TMF activities.\n\t</li>
<li>Provides technical and administrative support and coordination for projects in collaboration with relevant internal departments and team members to support the achievement of project target cycle times for site activations.\n\t</li>
<li>Assists with the negotiation and finalization of site agreements, budgets, and essential documents with study sites in accordance with local/accepted process.\n\t</li>
<li>Complies with established negotiation parameters, authority approval, contractual process and client expectations as developed and approved.\n\t</li>
<li>Works directly with site(s) to obtain documents related to site selection.\n\t</li>
<li>Assists with the preparation of regulatory compliance review packages, as applicable, which may include working directly with sites.\n\t</li>
<li>Assists in developing country or site-specific documents.\n\t</li>
<li>Provides support as needed to help with the coordination with internal functional departments to ensure site start-up activities within the site activation critical path are aligned.\n\t</li>
<li>Develops site list, including research from internal and external sources to ensure the site list is reflective of the defined site profile.\n\t</li>
<li>Ensure current investigator and site staff contact details are appropriately maintained in PPDsystems.\n\t</li>
<li>Completes the ‘Site Interest Plan’ in CTMS and collection and delivery of associated documents from investigators and site personnel. Document in real time all communication, attempts and follow up associated with site contact and survey responses.\n\t</li>
<li>Supports the review of survey data to ensure responses are logical, complete, and reflective of the question asked.\n\t</li>
<li>Works in collaboration with teammates to achieve targeted response goals for assigned projects.\n\t</li>
<li>Communicate with the team and appropriate clinical personnel regarding site issues and risks.\n\t</li>
<li>Ensures an efficient, effective plan is in place for site contact and follow up.\n\t</li>
<li>Ensure compliance with the plan and escalate concerns/non-compliance to management.\n\t</li>
<li>Acts as the local expert regarding site capacity and experience. Work with key local personnel to gather knowledge base and recommend additional sites.\n\t</li>
<li>Harnesses this knowledge base when performing local tiering of sites.\n\t</li>
<li>Conducts phone interviews, scripted or non-scripted, with physicians and other site personnel to discuss standard of care and obtain protocol-level input to support trial optimization projects.\n\t</li>
<li>Liaises with Global Investigator Services to resolve investigator queries in real time and maintain ‘accounts and contact’ information.\n\t</li>
<li>Contributes to the development and roll-out of global strategic feasibility processes and best practices.\n\t</li>
<li>Utilizes local knowledge to input into the identification and development of new sites within the local market.\n\t</li>
<li>Serves as a subject matter expert on feasibility survey tools and provides input on the development of future systems/releases.\n</li>
</ul>
\nEducation and Experience:\n\n
<ul>\n\t
<li>Preferring clinical research site management experience\n\t</li>
<li>High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.\n\t
<ul>\n\t\t
<li>Bachelor's degree preferred.\n\t</li>
</ul>
\n\t\n\t</li>
<li>Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 6 years).\n</li>
</ul>
\nKnowledge, Skills and Abilities:\n\n
<ul>\n\t
<li>Ability to work in a team or independently as required\n\t</li>
<li>Excellent organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively\n\t</li>
<li>Excellent ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency\n\t</li>
<li>Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines\n\t</li>
<li>Demonstrated ability to attain and maintain a good working knowledge of applicable Country\n\t</li>
<li>Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all nonclinical/clinical aspects of project implementation, execution, and closeout\n\t</li>
<li>Excellent English language and grammar skills and proficient local language skills as needed\n\t</li>
<li>Effective presentation skills\n\t</li>
<li>Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain\n\t</li>
<li>Knowledge and master all clinical trial database systems\n\t</li>
<li>Ability to successfully complete the organization’s clinical training program\n\t</li>
<li>Self-motivated, positive attitude and strong interpersonal skills\n\t</li>
<li>Ability to use problem-solving techniques applicable to constantly changing environment\n\t</li>
<li>Ability to provide constructive feedback and suggest improvements to department processes\n\t</li>
<li>Effective oral and written communication skills, with the ability to communicate effectively with medical personnel\n\t</li>
<li>Good negotiation skills\n\t</li>
<li>Basic medical/therapeutic area and medical terminology knowledge\n\t</li>
<li>Basic knowledge of local health systems\n\t</li>
<li>Excellent customer focus\n\t</li>
<li>Ability to work in a matrix environment\n\t</li>
<li>A proven relationship builder\n\t</li>
<li>An independent thinker\n\t</li>
<li>Ability to manage risk and perform risk escalation appropriately\n</li>
</ul>
 \n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\tAs part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community. 
Why Kelly® Science &amp; Clinical? 
 Kelly Science &amp; Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.\n\t\t\t \n\t\t\t \n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t
About Kelly
 Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year. Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. \n\t\t\t \n\t\t\t

Principal Clinical Trial Coordinator

<h3>Job Description</h3>
Job DescriptionSalary: 
Reporting to the Head of Clinical Operations, the Clinical Trial Lead (CTL) will lead and direct execution of clinical studies across multiple clinical programs. They will be responsible for overseeing the coordination, management, and operational aspects of assigned clinical studies to secure the successful completion of projects within prescribed time frame and funding parameters. The successful candidate will be responsible for the planning, implementation and conduct of clinical trials, or responsible for being the operational lead for a product and associated development program. 
The Sr. CTL will oversee some or all elements of clinical studies with oversight. The successful candidate will have solid knowledge of the processes involving clinical studies, a broad understanding of essential study documentation, be highly adaptable, solutions oriented, and can prioritize and manage timelines and key deliverables.
The Associate Director will additionally be expected to provide leadership within the Clinical Operations department and make recommendations with regards to the strategic aspects of clinical programs. They will work cross-functionally to identify and evaluate issues in the programs, interprets data on complex issues, make good business decisions and suggest and implement solutions. The Associate Director, with support from the Head of Clinical Operations, will be accountable for ensuring that all project deliverables meet the corporate and department expectations.
Responsibilities (Sr. CTL)
<ul>
<li> Participates in the internal cross-functional study team(s); Serve as key contact to other groups outside of Clinical Operations involved and contributing to the operational aspects of clinical trials</li>
<li> Participate in the selection and management of contract research organizations (CROs) and other outside vendors to support clinical studies</li>
<li> Manages external vendors, including CROs, central laboratories, and other external service providers, as necessary, from study start-up through final clinical study report</li>
<li> Assists in the preparation and review of the Protocol, Informed Consent, Case Report Forms and associated completion guidelines, and other study documents</li>
<li> Manages study timelines, budgets, and quality metrics in accordance with corporate objectives and goals</li>
<li> Lead and oversee study activities from study startup through closeout</li>
<li> Participate in the preparation and negotiation of clinical site and assigned CRO budgets and track variances</li>
<li> Adheres to standards and processes in compliance with applicable GCP/ICH guidelines and other regulatory requirements </li>
<li> Develops and maintains relationships with investigators and site personnel to support clinical study activities, including subject recruitment, and ensures protocol and regulatory compliance</li>
<li> Communicates study trends, issues, mitigation plans, and lessons learned to management</li>
<li> Manages study-related quality metrics </li>
<li> Manages multiple initiatives and shifts priorities within a small company environment</li>
<li> Provide routine updates to project team on study status/issues</li>
</ul>
Responsibilities (Associate Director)
<ul>
<li> Participate as a member of the Clinical Operations team involved in defining the strategic direction of the clinical development path for various trials </li>
<li> Manage internal clinical program staff and CROs, ensuring GCP compliance, proper training and staff development as appropriate </li>
<li> Lead clinical operations activities and process improvement initiatives; is the key individual to communicate updates to all team members involved </li>
<li> Keep up to date with industry practice and communicates key message back to team and provides recommendations accordingly </li>
<li> Able to present at departmental and interdepartmental meetings</li>
<li> Actively participate in the departmental goal setting and ensures individual goals align with the overall corporate goals</li>
<li> Be able to lead direct reports, and oversee the work of others including mentoring of staff on all assigned projects</li>
</ul>
Qualifications
<ul>
<li> Bachelors Degree.</li>
<li> CTL: 4-6 years of experience in clinical development.</li>
<li> AD: 6-8 years of experience in clinical development</li>
<li> Prior employment at a biotech in similar role preferred.</li>
<li> Experience managing complex schedules and priorities in dynamic environments.</li>
<li> Ability to influence others and work independently and in a team environment.</li>
<li> Driven and self-motivated with the ability to lead and facilitate priorities and activities across internal and external cross functional teams.</li>
<li> Agility, to quickly adjust and navigate shifting priorities, demands and timelines.</li>
<li> Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.</li>
<li> Excellent computer skills (Microsoft Office Word, Excel, Outlook) required.</li>
<li> Remote/Hybrid</li>
</ul>

Sr. Manager/ AD, Clinical Trial Lead

<h3>Job Description</h3>
Job DescriptionCompany Description 
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at&nbsp;<a href="http://www.abbvie.com" target="_blank">www.abbvie.com</a>. Follow @abbvie on&nbsp;X,&nbsp;Facebook,&nbsp;Instagram,&nbsp;YouTube,&nbsp;LinkedIn&nbsp;and&nbsp;Tik Tok.
Job Description 
AbbVie Data Science is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is key to ensuring successful delivery against the program and maintaining best in industry resources.
 Responsibilities:&nbsp;
<ul>
<li>Manage multiple TA</li>
<li>Manage technology evaluations and implementations for performance improvement and cost reduction.</li>
<li>Creates and sustains an environment that attracts, develops and retains strong talent.</li>
<li>Practice continuous improvement of processes and technology usage.</li>
<li>Acts as subject matter expert and process owner.</li>
<li>Supervises and allocates internal and external resources within the Therapeutic Area.</li>
<li>Ensure all performance assessment responsibilities are achieved for direct reports. Provide training and feedback, resolve personnel issues, and manage talent retention for assigned staff.</li>
<li>Responsible for the performance management of staff; supporting team in building and maintaining a high performing team, recruitment, onboarding, resource assignment, and development opportunities for staff within responsibility.</li>
<li>Manage cross functional initiatives.</li>
<li>Provides strategic direction, advice and guidance to staff in relation to operations responsibilities andactivities; promotes best practice; ensures objectives are successfully met.</li>
</ul>
*This is a US remote position&nbsp;
Qualifications 
<ul>
<li>Bachelor’s degree in management information systems, computer science, life sciences or equivalent.</li>
<li>Master’s preferred.</li>
<li>Must have 8+ years of experience with clinical database design, data loading, and database modeling concepts or 9+ years of experience in a similar technical or clinical development environment.</li>
<li>Demonstrated intermediate SAS and/or SQL programming skills and expert knowledge of database concepts.</li>
<li>In-depth knowledge of CDASH and SDTM Standards In-depth understanding of clinical trial processes</li>
<li>Demonstrated ability to influence others without direct authority. Demonstrated performance as a key contributor to initiatives and advancement of the organization. Demonstrated ability to successfully coach/mentor in a matrix environment Demonstrated effective communication skills Demonstrated effective analytical skills</li>
</ul>
 Additional Information 
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or&nbsp;local law:&nbsp;​
<ul>
<li>
The compensation range described below is the range of possible base pay compensation that the Company&nbsp;believes in&nbsp;good faith it will pay for this role at the time&nbsp;of this posting based on the job grade for this position.&nbsp;Individual&nbsp;compensation paid within this range will depend on many factors including geographic location, and&nbsp;we&nbsp;may ultimately&nbsp;pay more or less than the posted range. This range may be modified in the&nbsp;future. ​
</li>
<li>
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),&nbsp;medical/dental/vision&nbsp;insurance and 401(k) to eligible&nbsp;employees.​
</li>
<li>
This job is eligible to participate in our short-term incentive&nbsp;programs.&nbsp;​
</li>
<li>
This job is eligible to participate in our long-term incentive&nbsp;programs​
</li>
</ul>
​
Note: No amount of pay&nbsp;is considered to be&nbsp;wages or compensation until such amount is earned, vested, and&nbsp;determinable.&nbsp;The amount and availability of any bonus,&nbsp;commission, incentive, benefits, or any other form of&nbsp;compensation and benefits&nbsp;that are allocable to a particular employee remains in the Company's sole and&nbsp;absolute&nbsp;discretion unless and until paid and&nbsp;may be modified at the Company’s sole and absolute discretion, consistent with&nbsp;applicable law.&nbsp;
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.&nbsp;
US &amp; Puerto Rico only - to learn more, visit&nbsp;<a href="https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html" target="_blank">https://www.abbvie.com/join-us/equal-employment-opportunity-employer.ht…</a>
US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
<a href="https://www.abbvie.com/join-us/reasonable-accommodations.html" target="_blank">https://www.abbvie.com/join-us/reasonable-accommodations.html</a>

Senior Manager, Clinical Data Systems (REMOTE)

<h3>Job Description</h3>
Job DescriptionCompany Description 
Glycomine is a small clinical stage bio tech company committed to developing therapeutics for&nbsp; congenital disorders of glycosylation (CDG), serious rare diseases for which the vast majority of which do not have any disease-modifying treatment options available.&nbsp;Many of these diseases are driven by a genetic mutation that disrupts the function of an important enzyme. Glycomine’s lead clinical program in PMM2-CDG aims to deliver a substrate to bypass the enzymatic problem.&nbsp;
Our team has a special dedication to find solutions to the significant unmet medical need experienced by patients and families with rare diseases. We come from many disciplines and bring multiple viewpoints and broad expertise to our mission. We are driven by the imperative and the opportunity to develop therapies that can provide meaningful improvements in the quality of life for patients, caregivers, and families.
Job Description 
The Senior Clinical Project Manager/Clinical Project Manager is a team-player role responsible for supporting aspects of clinical operations for our programs. This individual possesses clinical operations expertise with a track record of success, working with peers and stakeholders across multiple disciplines to drive a key program with multiple studies and indications through all phases of clinical trials (Phase I-III). The Senior Clinical Project Manager/Clinical Project Manager is a role in the Clinical Development organization who knows how to work closely with vendors and clinical sites.
As a Senior Clinical Project Manager/Clinical Project Manager at Glycomine, you will play a pivotal role in driving the success of critical clinical programs. You'll provide support and experience to the program and members of our Clinical Development team to ensure the seamless execution of clinical trials. In this role, you'll collaborate across diverse functions, support key initiatives, and promote timely, on-budget trial completion that adheres to the highest quality standards.
You will be a member of a team that is responsible for the planning, implementation, execution, and management of clinical studies by overseeing day-to-day operations and directly managing and working with outside Clinical Research Organizations (CROs), clinical sites and their teams, and third-party vendors. You will thrive in a fast-paced, innovative environment, while remaining flexible, proactive, resourceful, and efficient. The ability to analyze complex issues to quickly develop relevant and realistic plans and recommendations for implementation is essential. Also necessary are excellent matrix management skills, written and verbal communication skills, attention to detail, and knowledge of quality obligations.
This is a remote based position ideally located in east coast time zone. Responsibilities include, but are not limited to the following:
<ul>
<li>Prepare or review site feasibility reports and support the study team in site selection.</li>
<li>Ensure efficient and through study start-up, by overseeing the CRO and vendors and working closely with relevant team members involved in study set up (CMC, Reg, etc). Ensure timeline collection of all start-up documents (example ethics documents for submission), site Clinical Trial Agreements and start up activities are performed prior to each site activation.</li>
<li>Work closely with the Director of Clinical Operations to review the study timelines and milestones are being met.</li>
<li>Manage the scope of work, change notifications, contract modification, site trial agreements, and other necessary budgetary information for clinical trial operations</li>
<li>Review site visits per Oversight Plan and conduct study oversights as needed.</li>
<li>Be responsible for oversight activities of vendors (example CRO, lab vendors, etc)</li>
<li>Assist in the preparation and implementation of study plans (example Monitoring Plan, Oversight Plan, etc).</li>
<li>Collaborate cross functionally with internal teams, including Clinical Development, Regulatory Affairs, Translational Medicine and Program Leadership to ensure alignment on clinical trial objectives and milestones</li>
<li>Serve as a point of contact for CROs and vendors, overseeing their performance and ensuring adherence to contractual agreements, timelines and quality standards</li>
<li>Ensure compliance with regulatory requirements, ICH-GCP requirements, and company SOPs throughout all stages of clinical trial conduct</li>
<li>Oversee the collection, analysis and interpretation of clinical trial data, working closely with Clinical Development, Biostatistics and Data Management teams to ensure data accuracy and integrity</li>
<li>Contribute, if needed, to the preparation and review of clinical study documents including the Investigator Brochure, Investigational New Drug Applications (IND), study protocols, clinical study reports, applicable sections of New Drug Applications (NDA) and or Marketing Authorization Application (MAA), updates to the IND, NDA and other safety reports.</li>
<li>Forge strong relationships with investigators, site staff, and CROs, effectively communicating study concepts while overseeing operational strategies for achieving program goals.</li>
<li>&nbsp;Contribute in review of operational risk management strategies</li>
<li>&nbsp;Part of the team who oversee the timely capture, reporting, and evaluation of adverse events and product safety issues.</li>
<li>Oversee clinical and regulatory files, including the essential Trial Master File (TMF).</li>
<li>Work cross-functionally to support the relevant and timely exchange of information and materials to support clinical trial deliverables</li>
<li>Be part of the team that manages clinical trials from start-up through close-out to ensure that both internal and external deliverables are on time and on budget while collaborating across functional areas</li>
<li>Proactively manage clinical trial outsourced partners, including identification of risk, to ensure trial deliverables and performance goals are met</li>
<li>Maintain partnerships through positive relationships with CRO counterparts; proactively review and identify potential issues or problems with the sites and communicate/escalate to clinical leadership</li>
<li>Collaborate with CROs to keep the clinical study database current, accurate, and routinely cleaned</li>
<li>Support and manage oversight activities of all necessary vendors to ensure a high level of operational excellence is maintained</li>
</ul>
Qualifications 
Qualifications:
<ul>
<li>BA/BS preferably in a health-related field; preferred MA/MS degree in biological, life science, nursing or related field but not required.</li>
<li>At least 5 years of experience in clinical operations within the pharmaceutical or biotechnology industry.</li>
<li>Strong experience in managing and developing relationships with contract research organizations (CROs).</li>
<li>Demonstrated excellence in managing clinical trials and a solid understanding of the trial processes.</li>
<li>Proven track record of success and a history of innovative program and trial execution to ensure study progress, timelines, data integrity, and compliance with health authority requirements.</li>
<li>Domain expertise in drug development, with a preference for experience in early-stage clinical trials.</li>
<li>Strong vendor and project management skills are critical.</li>
<li>Ability to manage multiple competing priorities and adapt to changes.</li>
<li>Strong communication, interpersonal, and problem solving skills.</li>
<li>Must be comfortable working in a fast-paced environment.</li>
<li>Global studies (multiple countries and sites) experience required.</li>
<li>Previous experience in the pediatric trials and rare disease is an asset.</li>
<li>Able to work in a team and within a multi-disciplinary environment.</li>
<li>Strong working knowledge of GCP/ICH and other applicable regulations/guidelines, required</li>
<li>Proactive approach</li>
<li>Languages: Strong written and verbal English required.</li>
<li>Travel Requirements: Domestic or internation travel may be required. The position is remote based, though travel will be necessary prerequisite in order to support the program.</li>
</ul>
 Additional Information 
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194 Remote Clinical Trial Manager Jobs