<h3>Job Description</h3>
Job DescriptionSalary: $62,000 - $77,000 
We are looking for an experienced Clinical Operations Manager I to join our team! 
 
Are you well organized, but 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!
This role is ideal for an individual who can motivate teams to do great work collaboratively in order to produce the best quality outcomes possible.
In this position you will:
<ul>
<li>Manage site identification and evaluation.</li>
<li>Develop or review essential study documents including protocols, case report forms (CRFs), source documents, project management plans, monitoring plans, reference tools, and study manuals.</li>
<li>Review site regulatory documents for compliance with CPC Standard Operating Procedures (SOPs) and applicable laws, regulations, and guidelines and to facilitate approval of investigational product release. </li>
<li>Prepare central IRB submissions and resolve IRB issues.</li>
<li>Manage site enrollment and study subject tracking and payments.</li>
<li>Assist with the monitoring of project deliverables and project timelines.</li>
<li>Develop and distribute project documents (e.g. safety reports, lab reports, deviations reports, monitoring reports, follow-up letters, meeting minutes, newsletters, and regulatory documents)</li>
<li>Identify project-specific training for team members and notify appropriate designee to ensure completion and filing of training documentation.</li>
<li>Provide investigational product or device tracking and disposition as required by project.</li>
<li>Develop and manage site and vendor contracts including investigational product (IP) supply, interactive voice/web response system, electronic data capture system, core labs and other applicable clinical services. </li>
<li>Track and approve vendor payments.</li>
<li>Manage multidisciplinary project team members in relation to their role on assigned projects. Proactively identify issues and discuss resolutions with applicable department heads, project team, CPC executives and/or the sponsor. Track implementation of resolution through to completion and efficacy checks.</li>
<li>Ensure that the overall quality of project services and deliverables is maintained.</li>
<li>Provide status reports on all projects.</li>
<li>Participate in both onsite and offsite investigator meetings and training sessions.</li>
<li>Escalate budget, proposals and change orders discussions to Business Development.</li>
<li>Assist Business Development with benchmarking for budgets and development of sponsor proposals and service agreements.</li>
<li>Ensure both CPC and sponsor are aware of and in agreement on any change in project scope that has a financial or resource impact. Routinely advise management regarding the overall project status.</li>
<li>Provide Head of Trial Master File scope of services to enable him/her to establish and maintain Trial Master Files (TMFs) and project document files, both electronic and paper. </li>
<li>Schedule project team meetings and prepare meeting agendas and minutes as needed.</li>
<li>Perform other non-project related general administrative tasks such as filing, copying, faxing and shipping for assigned projects. </li>
<li>Cross-train within the project team, as needed. </li>
<li>Define and monitor Endpoint and Specialty Services scope, timelines and deliverables from project initiation to closeout with assistance from study assigned Clinical Operations Manager and the Head of Endpoint and Specialty Services.</li>
<li>Provide timely feedback on the progress of project assignments; help assess project issues and propose resolutions to the CPC project lead.</li>
<li>Manage contracted deliverables for external committees (e.g. data safety monitoring boards, clinical endpoint committees), including but not limited to meeting scheduling, generation of meeting minutes and distribution of meeting materials.</li>
<li>Oversee SAE process and assure execution of safety plans.</li>
<li>Accurately track receipt, entry, upload and the processing of photos, acetate tracings, and other source documents submitted from sites. </li>
<li>Contact appropriate individuals (e.g., study site staff or study site Clinical Research Associate) regarding incomplete, inaccurate, or missing photos, acetate tracings, and other Endpoint and Specialty Services Core Lab documents as required by the project.</li>
<li>Oversee timely and accurate entry and cleaning of data for all study databases; maintain and file data management documentation as required.</li>
<li>Manage the acquisition and supply of project specific materials to study sites.</li>
<li>Provide feedback to study sites on tracing and quality issues, as required by project.</li>
<li>Manage and conduct Endpoint and Specialty Services CPC Core Lab activities. </li>
</ul>
Heres what you will need to bring to the table:
<ul>
<li>Nursing degree or BA/BS in a scientific field (or equivalent knowledge/experience)</li>
<li>3 years of experience in a clinical research setting (required) or 1 year of experience as a Research Assistant (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>Experience with clinical site startup preferred.</li>
<li>Proficiency in Microsoft Office, particularly Outlook, Word and Excel.</li>
<li>Excellent communication and organizational skills. </li>
<li>Great attention to detail. </li>
<li>Ability to interact with multiple individuals with varied skill sets in a positive, collaborative and educational manner.</li>
<li>Ability to adapt quickly to new situations, manage conflicts and resolve problems effectively.</li>
<li>Willingness to travel up to 25%.</li>
</ul>
Note:Viable applicants will be required to pass a background and education verification check.
 
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> 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 Operations Manager I

<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;Twitter,&nbsp;Facebook,&nbsp;Instagram,&nbsp;YouTube&nbsp;and&nbsp;LinkedIn.&nbsp;
Job Description 
AbbVie Clinical Data Strategy and Operations is the best-in-class team within its cross-industry peer group. We are 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 a key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences.&nbsp;&nbsp;&nbsp;
Responsibilities:
<ul>
<li>Develop a deep understanding of the capabilities and data flow for clinical technologies</li>
<li>Support the delivery of clinical technologies for a given program or therapeutic area</li>
<li>Track and analyze system timelines and metrics to ensure adherence to project plans, identify and mitigate potential risks and assess performance</li>
<li>Develop actionable reports and presentations for stakeholders and senior leadership to inform decision-making and project adjustments</li>
<li>Collaborate with internal and external stakeholders, including system leads, data management team, clinical teams and vendors</li>
<li>Contribute the strategic development of clinical technology initiatives and lead the implementation as the tech project manager</li>
<li>Maintain technical knowledge of the clinical data systems (EDC, IRT, eCOA, CDR and Imaging) and understand how the capability contributes to the submission data flow and overall DSS technology strategy</li>
<li>Mentor Clinical Data Strategy and Operations Associates</li>
<li>Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards</li>
<li>Act as the clinical data systems SME during regulatory inspections and internal quality audits</li>
</ul>
The preferred location for this role is AbbVie's Lake County, Illinois office on a hybrid onsite schedule; however, we are open to candidates working remotely within the United States.
Qualifications 
<ul>
<li>Bachelor’s degree in business, management information systems, computer science, life sciences, engineering or equivalent. Master’s preferred.</li>
<li>4+ years of pharmaceutical, clinical research, data management, health care technology experience or 6+ years of broader technology experience.</li>
<li>Familiar with clinical trial process and clinical technology.</li>
<li>Demonstrated knowledge of SAS and/or SQL programming skills and knowledge of database concepts.</li>
<li>Familiar with CDASH and SDTM Standards.</li>
<li>Demonstrated leadership traits and ability to influence without authority.</li>
<li>Demonstrated effective communication skills.</li>
<li>Demonstrated effective problem-solving and analytical skills.</li>
</ul>
 Additional Information 
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:&nbsp;​
​
<ul>
<li>
The compensation range described below is the range of possible base pay compensation that the Company believes in&nbsp;good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual&nbsp;compensation paid within this range will depend on many factors including geographic location, and we may ultimately&nbsp;pay more or less than the posted range. This range may be modified in the future.​
</li>
<li>
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision&nbsp;insurance and 401(k) to eligible employees.​
</li>
<li>
This job is eligible to participate in our short-term incentive programs.&nbsp;​
</li>
</ul>
​
Note: No amount of pay&nbsp;is considered to be&nbsp;wages or compensation until such amount is earned, vested, and determinable.&nbsp;The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits&nbsp;that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and&nbsp;may be modified at the Company’s sole and absolute discretion, consistent with 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>

Clinical Data Systems Lead (Onsite or Remote)

<h3>Job Description</h3>
Job Description
Company introduction:
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, and has offices in New York City and San Francisco in the US. We focus on developing innovations that can improve the lives of those who are suffering with mental health challenges and who are not helped by current treatments. 
We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin (which has received breakthrough therapy designation from the FDA) is administered with psychological support. We are currently in phase 3 study for treatment-resistant depression (TRD), and phase 2 for both post-traumatic stress disorder and anorexia nervosa. Our vision is a world of mental wellbeing - Compass Pathways.
Job overview:
The Clinical Project Coordinator will be responsible for supporting the planning, coordination, and implementation of clinical research projects. They will also monitor and present project updates to relevant stakeholders, clients, or project team members.
Location: Remote on the East Coast, USA or Hybrid in our New York City office. 
Reports to: Manager, Clinical Project Coordination.
Roles and responsibilities Responsibilities include (but are not limited to): 
<ul>
<li>
Supports members of the Clinical Operations and Therapist Training team in the planning and conduct of cross-functional clinical research projects
</li>
<li>
Provides day-to-day operational support for all Compass Pathways clinical trials
</li>
<li>
Liaises with clinical trial sites to develop and implement creative solutions to address recruitment barriers/challenges
</li>
<li>
Works closely with external collaborators, including CROs and clinical vendors, to provide robust support to clinical trial sites
</li>
<li>
Monitors project deliverables and updates relevant stakeholders or team members on project progress, where appropriate
</li>
</ul>
Candidate Profile:
<ul>
<li>
Bachelor's Degree or equivalent experience
</li>
<li>
Experience in a clinical research setting, ICH and GCP
</li>
<li>
Excellent interpersonal, verbal and, written communication skills
</li>
<li>
Ability to manage multiple projects and tight deadlines
</li>
<li>
Working knowledge of the key elements of clinical trial operations
</li>
<li>
Experience in Pharma/Biotech, CRO and/or academic research is essential
</li>
<li>
An inquiring mind and great enthusiasm to work in an exciting and fast-moving environment
</li>
<li>
Aligned to our company mission and values of Compassionate, Bold, Rigorous and Inclusive
</li>
</ul>
【For NYC】Compensation Description (annually):
Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity.
【Base salary per annum】:$80,000—$100,000 USDBenefits &amp; Compensation:
For an overview of our benefits package and compensation information, please visit "Working at Compass". 
Equal opportunities: 
UK applicants
We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability.
US applicants
Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law.
Sponsorship:
Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying.
Data Privacy:
All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Clinical Project Coordinator

<h3>Job Description</h3>
Job DescriptionSalary: $72,000 - $95,000 
We are looking for an experienced Clinical Operations Manager II to join our team! 
 
Are you well organized, but 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!
This role serves as the primary point of contact for industry sponsored clinical trials, Endpoint and Specialty Services activities and also provides operational support for biostatistics and programming deliverables.
 
Remote candidates are welcome to apply.
In this position you will:
<ul>
<li>Oversee clinical operations management activities.</li>
<li>Define and monitor project scope, timelines and deliverables from project initiation to close-out.</li>
<li>Identify project-specific training for team members and notify appropriate designee to ensure completion and filing of training documentation.</li>
<li>Oversee trial-related activities.</li>
<li>Track and approve vendor payments.</li>
<li>Provide expert advice in the design, writing and/or review of all project-related essential documents including protocols, project management plans, case report forms, statistical analysis plans, project management plans, ICF templates, study procedure manuals, source documents, site newsletters, study reports, resource tools, essential documents, monitoring plans and report templates.</li>
<li>Develop and manage multidisciplinary project team members. Organize, plan for, and produce minutes for project team meetings.</li>
<li>Ensure the overall quality of project services and deliverables.</li>
<li>Provide necessary updates and reports to the sponsor as outlined by the contract.</li>
<li>Plan and oversee the execution of investigator meetings as contracted.</li>
<li>Work with the Business Development team on budgets, proposals and change orders.</li>
<li>Ensure both CPC and sponsor are aware of and in agreement on any change in project scope that has a financial or resource impact.</li>
<li>Provide Head of Trial Master File scope of services to enable him/her to establish and maintain Trial Master Files (TMFs) and project document files, both electronic and paper.</li>
<li>Adhere to local, federal and international regulations, guidelines and CPC Policies, Standard Operating Procedures (SOPs) and Work Instructions (WIs). Use appropriate discretion to proactively identify when there is a need to deviate from policies, procedures or plans and ensure deviations are appropriately documented.</li>
<li>Define and monitor Endpoint and Specialty Services scope, timelines and deliverables from project initiation to closeout with assistance from study assigned Clinical Operations Manager and the Head of Endpoint and Specialty Services.</li>
<li>Manage contracted deliverables for external committees (e.g. data safety monitoring boards, clinical endpoint committees), including but not limited to meeting scheduling, generation of meeting minutes and distribution of meeting materials.</li>
<li>Oversee SAE process and assure execution of safety plans.</li>
<li>Accurately track receipt, entry, upload and the processing of photos, acetate tracings, and other source documents submitted from sites.</li>
<li>Contact appropriate individuals (e.g., study site staff or study site Clinical Research Associate) regarding incomplete, inaccurate, or missing photos, acetate tracings, and other Endpoint and Specialty Services Core Lab documents as required by the project.</li>
<li>Oversee timely and accurate entry and cleaning of data for all study databases; maintain and file data management documentation as required.</li>
<li>Provide feedback to study sites on tracing and quality issues, as required by project.</li>
<li>Manage and conduct Endpoint and Specialty Services CPC Core Lab activities.</li>
<li>Provide operational support for the biostatistics and programming deliverables.</li>
</ul>
Heres what you will need to bring to the table:
<ul>
<li>Nursing or BA/BS in a scientific field (or equivalent knowledge/experience).</li>
<li>4 years of experience in a clinical research setting, preferably with at least 2 years of project/operations management experience in clinical research.</li>
<li>Demonstrated ability to adequately manage all facets of a clinical trial with minimal direction.</li>
<li>Thorough knowledge of the Good Clinical Practice guidelines and applicable FDA and ICH regulations for conducting clinical drug trials.</li>
<li>Proficiency in Microsoft Office, particularly Outlook, Word and Excel.</li>
<li>Excellent communication and organizational skills.</li>
<li>Great attention to detail.</li>
<li>Exemplary skills leading and managing multi-disciplinary teams in a clinical research setting.</li>
<li>Ability to organize, instruct and oversee project staff, while promoting group effort and achievement.</li>
<li>Ability to adapt quickly to new situations, manage conflicts and resolve problems effectively.</li>
<li>Willingness to travel 20-25%.</li>
</ul>
Note:Viable applicants will be required to pass a background and education verification check.
 
Targeted Compensation: $72,000 - $95,000 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

Clinical Operations Manager II

<h3>Job Description</h3>
Job DescriptionSalary: $72,000 - $95,000 
We are looking for an experienced Clinical Operations Manager II to join our team! 
 
Are you well organized, but 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!
This role serves as the primary point of contact for industry sponsored clinical trials, Endpoint and Specialty Services activities and also provides operational support for biostatistics and programming deliverables.
 
Remote candidates are welcome to apply.
In this position you will:
<ul>
<li> Oversee clinical operations management activities. </li>
<li> Define and monitor project scope, timelines and deliverables from project initiation to close-out.</li>
<li> Identify project-specific training for team members and notify appropriate designee to ensure completion and filing of training documentation.</li>
<li> Oversee trial-related activities.</li>
<li> Track and approve vendor payments.</li>
<li> Provide expert advice in the design, writing and/or review of all project-related essential documents including protocols, project management plans, case report forms, statistical analysis plans, project management plans, ICF templates, study procedure manuals, source documents, site newsletters, study reports, resource tools, essential documents, monitoring plans and report templates.</li>
<li> Develop and manage multidisciplinary project team members. Organize, plan for, and produce minutes for project team meetings.</li>
<li> Ensure the overall quality of project services and deliverables.</li>
<li> Provide necessary updates and reports to the sponsor as outlined by the contract.</li>
<li> Plan and oversee the execution of investigator meetings as contracted.</li>
<li> Work with the Business Development team on budgets, proposals and change orders.</li>
<li> Ensure both CPC and sponsor are aware of and in agreement on any change in project scope that has a financial or resource impact. </li>
<li> Provide Head of Trial Master File scope of services to enable him/her to establish and maintain Trial Master Files (TMFs) and project document files, both electronic and paper. </li>
<li> Adhere to local, federal and international regulations, guidelines and CPC Policies, Standard Operating Procedures (SOPs) and Work Instructions (WIs). Use appropriate discretion to proactively identify when there is a need to deviate from policies, procedures or plans and ensure deviations are appropriately documented.</li>
<li> Define and monitor Endpoint and Specialty Services scope, timelines and deliverables from project initiation to closeout with assistance from study assigned Clinical Operations Manager and the Head of Endpoint and Specialty Services.</li>
<li> Manage contracted deliverables for external committees (e.g. data safety monitoring boards, clinical endpoint committees), including but not limited to meeting scheduling, generation of meeting minutes and distribution of meeting materials.</li>
<li> Oversee SAE process and assure execution of safety plans.</li>
<li> Accurately track receipt, entry, upload and the processing of photos, acetate tracings, and other source documents submitted from sites. </li>
<li> Contact appropriate individuals (e.g., study site staff or study site Clinical Research Associate) regarding incomplete, inaccurate, or missing photos, acetate tracings, and other Endpoint and Specialty Services Core Lab documents as required by the project.</li>
<li> Oversee timely and accurate entry and cleaning of data for all study databases; maintain and file data management documentation as required.</li>
<li> Provide feedback to study sites on tracing and quality issues, as required by project.</li>
<li> Manage and conduct Endpoint and Specialty Services CPC Core Lab activities.</li>
<li> Provide operational support for the biostatistics and programming deliverables.</li>
</ul>
Heres what you will need to bring to the table:
<ul>
<li> Nursing or BA/BS in a scientific field (or equivalent knowledge/experience).</li>
<li> 4 years of experience in a clinical research setting, preferably with at least 2 years of project/operations management experience in clinical research.</li>
<li> Demonstrated ability to adequately manage all facets of a clinical trial with minimal direction.</li>
<li> Thorough knowledge of the Good Clinical Practice guidelines and applicable FDA and ICH regulations for conducting clinical drug trials.</li>
<li> Proficiency in Microsoft Office, particularly Outlook, Word and Excel.</li>
<li> Excellent communication and organizational skills.</li>
<li> Great attention to detail. </li>
</ul>
<ul>
<li>Exemplary skills leading and managing multi-disciplinary teams in a clinical research setting.</li>
<li>Ability to organize, instruct and oversee project staff, while promoting group effort and achievement.</li>
<li>Ability to adapt quickly to new situations, manage conflicts and resolve problems effectively.</li>
</ul>
<ul>
<li> Willingness to travel 20-25%.</li>
</ul>
Note:Viable applicants will be required to pass a background and education verification check.
 
Targeted Compensation: $72,000 - $95,000 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 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 
The Senior Manager, Clinical Data and Reporting Standards (CDARS) proactively participates in the development of data and reporting standards in support of AbbVie’s portfolio of clinical trials and ensures AbbVie’s conformance to CDISC standards and industry best practices. This role implements the strategy and framework for governance of standards as set by the Head and Associate Directors of CDARS, and actively engages in deployment of next generation process and technology.
Standards Development responsibilities include
<ul>
<li>Actively participating with a cross-functional team of subject matter experts to define one more of the following types of standards within the assigned therapeutic areas:
<ul>
<li>SDTM mapping</li>
<li>Data Collection</li>
<li>Data Review Rules</li>
</ul>
</li>
<li>Participating in a cross-functional team of subject matter experts to define one more of the following types of standards within the assigned therapeutic areas:
<ul>
<li>Study-level tables, listings, or figures</li>
<li>Product-level safety analysis displays</li>
<li>ADaM mapping and derivation</li>
</ul>
</li>
<li>Ensuring each standard is clearly defined, with appropriate documentation of relevant assumptions and decisions related to its use to support pipeline activities</li>
<li>Ensuring consistency across standard types (e.g. eCRF standards align with TLF standards, SDTM standards align with ADaM standards, etc.)</li>
<li>Develop training materials to the organization on the proper use of standards in pipeline activities</li>
<li>Communicate ongoing standard development activities across the organization</li>
</ul>
Pipeline responsibilities include
<ul>
<li>Create, review, and provide feedback on SDTM Mapping Specifications and Trial Design Domains</li>
<li>Providing feedback on CRF design and SDTM datasets to ensure data are collected and represented in a manner that support regulatory requirements to comply with CDISC standards (CDASH, SDTM and ADaM) and AbbVie standard extensions to CDISC</li>
<li>Oversee the creation of SDTM define.xml, annotated CRF and Clinical Study Data Reviewer’s Guides for both FDA and PMDA submissions</li>
<li>Consult on conformance issues for SDTM and/or ADaM and work with the study team to resolve the problem either by correcting the data or metadata, or by providing an appropriate explanation</li>
</ul>
Other responsibilities include:
<ul>
<li>Representing AbbVie’s interests in industry standards development projects</li>
<li>Staying current with industry standards such as CDISC, and the regulatory requirements related to their use</li>
<li>Identifying improvements to the processes and content of standards, and driving those improvements to completion</li>
<li>Mentor junior team members</li>
</ul>
Qualifications 
This is a remote opportunity that can be hired anywhere in the US&nbsp;
<ul>
<li>Experience leading development of standards for data collection, tabulation, analysis and/or reporting</li>
<li>Experience with SDTM is required</li>
<li>Experience with CDASH is highly recommended</li>
<li>Experience with ADaM, Analysis Results Metadata, or TLF standards is helpful</li>
<li>Active participation in CDISC teams preferred</li>
<li>Experience with preparing SDTM datasets and documentation for regulatory submissions</li>
</ul>
Education and experience requirements
<ul>
<li>MS with 9 years of relevant clinical research experience, or</li>
<li>BS with 11 years of relevant clinical research experience</li>
</ul>
 Additional Information 
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:&nbsp;​​
​​
<ul>
<li>
The compensation range described below is the range of possible base pay compensation that the Company believes in&nbsp;good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual&nbsp;compensation paid within this range will depend on many factors including geographic location, and we may ultimately&nbsp;pay more or less than the posted range. This range may be modified in the future.​​
</li>
<li>
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision&nbsp;insurance and 401(k) to eligible employees.​​
</li>
<li>
This job is eligible to participate in our short-term incentive programs.&nbsp;​​
</li>
</ul>
​​
Note: No amount of pay&nbsp;is considered to be&nbsp;wages or compensation until such amount is earned, vested, and determinable.&nbsp;The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits&nbsp;that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and&nbsp;may be modified at the Company’s sole and absolute discretion, consistent with 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, Data Standards (Remote)

<h3>Job Description</h3>
Job Description
 
As a pharmaceutical support industry leader, UBC is devoted to empowering health solutions for a better tomorrow. We take pride in improving patient outcomes and advancing healthcare. At UBC we provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation.
Embark on a rewarding career journey with UBC! Grow your career while making a meaningful impact on the world around you. UBC fosters a culture built on our Core Values being Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in an inclusive workplace that fosters creativity. 
If you are seeking a career that will challenge, inspire, and reward you, join us at UBC!
Brief Description: 
Patients are at the center of AbbVie’s business strategies. The Non-Clinical Supervisor is responsible for: the day-to-day operations of a team of associates in a call center and monitors productivity and performance standards. Plans and directs workflow and project assignments. Oversees call volume to ensure service standards are met. Conducts hiring, training, and evaluation of staff. Responsible for team’s adherence to corporate attendance and employment policies. Works with the Call Center Manager to develop policies, procedures and the business work plan for the team. Recognizes and recommends operational improvements. Supervises the daily activities of business support, technical support or production team at entry level and/or at non-exempt levels using established policies and procedures. Coordinates work with other supervisors. Work is reviewed for overall quality and efficiency. Ensures that daily tasks are completed on schedule following established procedures and schedules. Failure to achieve results might cause delays in work output. 
Specific job duties:
Responsible for implementing and maintaining the effectiveness of the program by:
<ul>
<li>Manage team of call center associates to promote a working team environment and ensure best practices are shared.</li>
<li>Works to develop employee’s skills, evaluates performance and provides feedback.</li>
<li>Oversees resolution of employee relations issues and performance standards, productivity and service standards.</li>
<li>Conducts hiring, training, and evaluation of staff.</li>
<li>Provide on-going coaching to each Customer Service Associate (CSA) on their team concerning quality, reliability, accountability and productivity.</li>
<li>Ensure service levels and performance guarantees are met.</li>
<li>Work with Call Center Manager to implement strategic business work plan goals.</li>
<li>Tracks and periodically reports progress to management.</li>
<li>Assist in development of Call Center programs and process improvements to enhance the level of internal and external customer service provided.</li>
<li>Serve as a point of escalation for calls requiring a higher degree of expertise or discretion to resolve customer issues and ensure timely resolution.</li>
<li>Backup platform team.</li>
<li>May take overflow calls.</li>
<li>Special projects as assigned.</li>
</ul>
Supervisory Responsibility: 
12 – 20 Direct Reports
Desired Skills and Qualifications:
<ul>
<li>BS/BA degree or 6 – 8 years of relevant business experience</li>
<li>Up to 2 years of experience in a customer service setting; prefer one year experience UBC call center; previous supervisory experience helpful</li>
<li>General PC knowledge including MS Office, Internet and email</li>
<li>Excellent phone oral and written communication skills</li>
<li>Demonstrated leadership skills including ability to effectively develop and assist team members, experience training and coaching less experienced staff with the patience to explain details and processes repeatedly</li>
<li>Advanced problem solving skills and the ability to work collaboratively with other departments to resolve complex issues with innovative solutions</li>
<li>Knowledge of UBC call center systems and platforms, UBC products/services very helpful; PBM and/or Managed Care industry preferred</li>
<li>Ability to adapt to a dynamic working environment and make independent decisions</li>
<li>Demonstrated ability to handle challenging customers in a professional manner</li>
</ul>
Benefits:
At UBC, employee growth and well-being are always at the forefront. We offer an extensive range of benefits to ensure that you have everything you need to thrive personally and professionally.
Here are some of the exciting perks UBC offers:
Remote opportunities
Competitive salaries
Growth opportunities for promotion
401K with company match*
Tuition reimbursement
Discretionary PTO (Paid Time Off)
Paid Holidays
Employee assistance programs
Medical, Dental, and vision coverage
HSA/FSA
Telemedicine (Virtual doctor appointments)
Wellness program
Adoption assistance
Short-term disability
Long term disability
Life insurance
Discount programs
UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state, or local protected class. We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.
 #LI-Remote

Call Center Supervisor (Non-Clinical)-AbbVie

<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 
The Clinical Operations Program Director is responsible to connect science and operations to bring clinical studies to life through the execution of one or more clinical research programs .The Clinical Operations Program Director serves as a strategic advocate for pipeline assets and provides operational reality to our scientific experiments via scientific expertise, strategic thinking, a global mindset and innovative solutions to address risks and challenges. The Clinical Operations Program Director also serves as a inspiring people leader responsible for developing a pipeline of talent for the Development Operations organization.
Responsibilities
Integral member of the Pipeline Commercialization Model’s Integrated Evidence Strategy Team and a strategic partner for the Asset Strategy Team and Development Review Committee whose remit is to maximize the value of our assets and portfolio for patients and AbbVie.
<ul>
<li>In alignment with the asset’s strategy and incorporating the science and the operations, develops the clinical operational strategy and is responsible for the execution of clinical studies/programs (e.g., generation of operational timelines, enrollment options, assessment of availability of the patient population, balancing complexity of trial designs vs speed)</li>
<li>Responsible for the programmatic evaluation of risks and mitigations to achieving the asset strategy. Identifies strategic options for the Asset Strategy Team to evaluate in the face of competing priorities, interests or unanticipated challenges.</li>
<li>Interacts with and influences all levels of management and cross-functional team members to achieve program objectives: primary scope of influence is within Development Operations, cross-functional colleagues who support clinical trial execution and the Development and Global Medical Affairs Therapeutic Area MDs/SDs.</li>
<li>Key contributor to the portfolio planning process including responsibility for the development of the costs, resource projections and timelines for the clinical development programs under consideration.</li>
<li>Reviews and provides clinical operations content to clinical and regulatory documents (e.g., INDs, IB, NDAs, BLAs, MAA, Regulatory Briefing Books)</li>
<li>Responsible for overall external budget management across their portfolio (programs can be 20-200 million dollars)</li>
<li>Leads large scoped, cross-functional innovation and process improvement initiatives with significant business impacts and ensures effective change management across the cross-functional areas that support clinical program execution.</li>
<li>Responsible for developing, managing, mentoring clinical operations (direct and indirect) staff to enable growth into leadership roles, including strategic leadership and direct supervision of 4 – 15 study manager(s) and up to 30 indirect staff, career development of clinical operations staff and creating an inclusive, innovative and learning environment where staff and studies/programs will succeed</li>
<li>Responsible for executing clinical programs in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures)</li>
</ul>
Qualifications 
<ul>
<li>Bachelor’s degree or equivalent is required, typically in nursing or scientific field. An Associate’s degree/R.N. or equivalent with relevant experience is acceptable.</li>
<li>Must have 12+ years of Pharma-related/ clinical research related experience (and/or applicable work experience)</li>
<li>10 years (and/or applicable work experience) in clinical research demonstrating a high level of core, technical, and leadership competencies through setting and driving study strategy and leading a global team in the management and completion of multiple clinical studies.</li>
<li>Experience in risk management, decision-making, strategic execution is critical to project and program success and ensuring pipeline decisions can be made on sound data.</li>
<li>Possesses good communication skills.</li>
<li>Demonstration of successful coaching, mentoring, and people management (remote management experience preferred).</li>
<li>Considered a subject matter expert in the application of standard business procedures (International Conference on Harmonization (ICH), Global Regulations, Ethics and Compliance).</li>
<li>Integral participation in initiatives or advancement of strategies for clinical operations.</li>
<li>Experience in successful study initiation through study completion, primary data analysis, and/or in multiple phases of studies (Phase l-3, 4).</li>
</ul>
Key Stakeholders&nbsp;
Global Regulations, SOPs, ICH
 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>

202 Remote Clinical Trial Manager Jobs