<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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6Ko5nhQss7

Senior Manager, Clinical Trial Transparency & Disclosure (Remote)

<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&nbsp;<a href="http://www.mmsholdings.com&nbsp;or" target="_blank">www.mmsholdings.com&nbsp;or</a> follow MMS on&nbsp;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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cTExMoQFX9

<h3>Job Description</h3>
Job DescriptionThe Clinical Trial Manager (CTM) oversees the planning, implementation and management of clinical trials to ensure they are conducted efficiently, ethically, and in compliance with regulatory guidelines. The CTM plays a critical role in coordinating cross functional teams, maintaining budgets, timelines, and quality standards, and ensuring the successful execution of clinical studies. Duties and Responsibilities (Responsibilities include but are not limited to): Study Planning and Execution:
<ul>
<li>Lead the design and implementation of clinical trial protocols, including site selection, patient recruitment strategies, and timeline development.</li>
<li>Contributing to the development of study protocols, protocol amendments, study manuals, Informed Consent Forms (ICFs), Case Report Forms (CRFs), Investigator Brochures (IBs) and other study-related documents as require</li>
<li>Oversee implementation and maintenance of Trial Master File for inspection readiness</li>
</ul>
Project Management:
<ul>
<li>Manage all aspects of clinical trial operations, ensuring adherence to timelines, budgets, and regulatory requirements.</li>
<li>Participate in the identification, evaluation, selection, and oversight of clinical trial sites in collaboration with the Clinical Research Organization (CRO)</li>
<li>Manage external vendors with oversight of activities</li>
<li>Review invoices and track study budget according to the forecast, working closely with finance and clinical business operations</li>
</ul>
Team Leadership:
<ul>
<li>Collaborate with cross-functional teams including clinical research associates, data managers, and regulatory affairs to ensure successful trial execution.</li>
</ul>
Site Management:
<ul>
<li>Establish and maintain strong relationships with clinical trial sites. Provide ongoing support and oversight to ensure compliance with protocol and regulatory standards.</li>
</ul>
Data Integrity and Compliance:
<ul>
<li>Monitor trial progress, ensuring accurate data collection, timely reporting, and adherence to Good Clinical Practice (GCP) guidelines.</li>
</ul>
Risk Management:
<ul>
<li>&nbsp;Identify potential study risks and develop mitigation strategies to ensure successful trial outcomes.</li>
</ul>
Communication:
<ul>
<li>Prepare and present updates to stakeholders, including internal teams and external partners. Facilitate regular meetings to discuss study progress and address challenges.</li>
</ul>
Requirements:
<ul>
<li>B.S. degree with minimum 6-8+ years of experience managing clinical trials in biotech, pharmaceutical</li>
<li>Strong clinical study conduct experience from start-up through close-out, with global trial and CRO management experience</li>
<li>Experience with phase II, III study oversight and management</li>
<li>Experience with timeline management</li>
<li>Strong leadership, effective decision making, and problem-solving skills required</li>
<li>Document reviews in relevant systems with a focus on inspection readiness</li>
<li>Working knowledge of relevant GCPs and FDA, EMA and MHRA regulations</li>
<li>Demonstrated experience using various EDC, CTMS and eTMF (Veeva, Agatha) systems. Experience with operational financial tracking systems a plus</li>
<li>Demonstrated proficiency using MS Office applications, including MS Word, Excel, PowerPoint</li>
<li>Experience using Smartsheet</li>
<li>Ability to work effectively with minimal supervision and multi-task activities to effectively manage deliverables across all trials</li>
<li>Excellent written and verbal communication skills</li>
</ul>
Working Environment and Travel: Generally accepted office working conditions Travel up to 25% - ability to travel domestically and internationally Prefer candidates located in Central or Eastern Time Zones Physical Requirements:&nbsp; While performing the duties of this job, the employee is regularly required to walk, stand and sit. The employee will be able to use a computer for extended periods at any given time. The employee must regularly lift and/or move up to 10 pounds. ADA:&nbsp; The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990. SAB Bio is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. SAB Bio is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status.&nbsp;EOE/AA/Vets&nbsp; #LI-Remote &nbsp;
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crs8JlJXoZ

Clinical Trial Manager, Immunology

<h3>Job Description</h3>
Job Description
We are looking for an Associate Director of Clinical Trial Operations to join our team!
APPLY DIRECTLY at <a href="https://cpcclinicalresearch.org/careers/" target="_blank">https://cpcclinicalresearch.org/careers/</a> 
Are you a self-driven leader who can provide excellent leadership and oversight to the Operations team while promoting team effort and accountability? Can you quickly respond to unexpected changes and make sound decisions? Someone who is able to see the bigger picture without losing sight of the day-to-day tasks? If so, keep reading!
This role is ideal for an individual who can motivate cross-functional teams to collaboratively work together to produce the best quality outcome and foster positive relationships.
Responsibilities:
Strategic Input 
<ul>
<li>Support the Director of Operations and Executive Director in defining and carrying forward strategic objectives at the organizational level.</li>
<li>Support the development and implementation of annual goals and performance metrics for the CPC Operations teams (Clinical Operations, Site Operations, and Endpoint &amp; Specialty Services [ESS]) in collaboration with functional area leaders and the Leadership Committee.</li>
<li>Ensure proactive assessment and identification of project issues by functional area leaders and support teams in developing and implementing risk mitigation strategies.</li>
</ul>
Leadership and Management 
<ul>
<li>Provide oversight, management, and leadership for Operations.</li>
<li>Supervise, coach, and mentor team members, setting clear job expectations, assessing training needs, and ensuring team members receive necessary training.</li>
</ul>
Quality and Compliance 
<ul>
<li>Oversee the quality, accuracy, and timeliness of deliverables from the Operations teams.</li>
<li>Ensure CPC Operations teams’ compliance with applicable policies, standard operating procedures (SOPs), work instructions (WIs), and relevant regulations and guidelines.</li>
<li>Review, and approve applicable policies, SOPs, and WIs. Work closely with team members to create and improve these documents.</li>
</ul>
Project Management 
<ul>
<li>Function as an Executive Clinical Operations Manager or Project Manager for projects, as needed.</li>
<li>Provide mentoring, support, and backup for all relevant project activities.</li>
<li>Provide regular updates to supervisors on staff, key performance indicators, timelines, and deliverables.</li>
<li>Work with the team to identify and implement best practices for optimizing performance and increasing efficiencies.</li>
</ul>
Resource Allocation
<ul>
<li>Ensure appropriate resourcing and personnel allocation for evolving business and project needs within Operations.</li>
</ul>
Business Development 
<ul>
<li>Assist Business Development with benchmarking for budgets and development of proposals and service agreements.</li>
</ul>
Executive Management
<ul>
<li>Support the Director of Operations, Director of Informatics, Biostatistics and Data Management and Leadership Committee to ensure optimal procurement, implementation, and adoption of systems used to support the CPC Operations team; identify and support system owners.</li>
<li>Oversee the accurate and timely recognition of project specific revenue; ensure accurate revenue forecasting for all assigned projects.</li>
</ul>
Perform additional activities as required.
Qualifications:
<ul>
<li>BA/BS in a scientific field. Advanced degree preferred.</li>
<li>A minimum of 10 years of experience clinical research (or equivalent) experience</li>
<li>A minimum of 5 years in clinical trial management (or equivalent) experience</li>
<li>A minimum of 3 years of supervisory experience</li>
<li>Thorough knowledge of Good Clinical Practice guidelines and applicable FDA and ICH regulations for conducting clinical drug trials</li>
<li>Proficiency in MS Office including Project, PowerPoint, Word, and Excel</li>
<li>Excellent interpersonal communication skills</li>
<li>Strong analytical and reasoning skills</li>
<li>Ability to work as a member of a team and to organize, instruct, and supervise staff while promoting group effort and achievement</li>
<li>Ability to manage conflicts and resolve problems effectively</li>
<li>Commitment to accountability and passion for the organization's mission, vision, and values</li>
<li>Ability and willingness to travel up to 15%</li>
</ul>
Targeted Compensation: $125,000 - $140,000 annually
Deadline to Apply: July 1, 2025
Company DescriptionAbout 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 35 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: * Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.) * Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately) * 11 paid holidays * 15 - 25 vacation days based on years of service * Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours) * Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics) * Flexible and remote work schedules available for certain positions Visit our web site to learn more about us and values we embrace: <a href="https://cpcclinicalresearch.org/" target="_blank">https://cpcclinicalresearch.org/</a>. 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>. 
<h3>Company Description</h3>
About CPC:\r\nCPC 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 35 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. \r\n\r\nCPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials.\r\n\r\nCPC 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> \r\n\r\nCPC offers:\r\n* Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)\r\n* Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)\r\n* 11 paid holidays\r\n* 15 - 25 vacation days based on years of service\r\n* Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours) \r\n* Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)\r\n* Flexible and remote work schedules available for certain positions\r\n\r\nVisit our web site to learn more about us and values we embrace: <a href="https://cpcclinicalresearch.org/" target="_blank">https://cpcclinicalresearch.org/</a>.\r\n\r\nAn Equal Opportunity Employer\r\nCPC 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.\r\n\r\nApplicants 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>.

Associate Director, Clinical Trial Operations - remote

<h3>Job Description</h3>
Job DescriptionSalary: $72,000 - $90,000 
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: August 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 35 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: $81,000 - $120,000 
Clinical Trial Project Manager - United States of America
Clinaxel is part of a group of Animal Health Contract Research Organizations servicing the global animal health industry.
 
We're actively seeking a North American basedClinical Trial Project Managerto join our expanding field clinical trials team. This role provides the flexibility to work remotely, with occasional office visits required. 
 
This position presents an exciting opportunity for professional growth and development in the Animal Health industry. 
Primary Job Purpose
Coordinate Field Clinical Trials (FCT) processes and resources, including data management, Monitors, QA support, legal, finance teams, study Investigators, laboratories, and couriers.
 
Manage communication with the Sponsor and ensure FCT's quality and timely completion per company SOPs, policies, practices, and Sponsor's expectations. 
Job Specific Duties and Responsibilities
<ul>
<li>Coordinate FCT across all their phases (e.g., feasibility assessment, quotation, set up, live phase, close-out, reporting, and study master file compilation), liaise with the responsible team members for the services performed within the group, and manage the relationship with external partners and vendors.</li>
<li>Ensure projects complete their life cycle and deliverables meet the agreed timelines, quality, and cost.</li>
<li>Report to management and Sponsors on the status of projects, including budgets and timelines, through the implementation and coordination of regular project review meetings.</li>
<li>Proactively identify risks that might jeopardize projects, e.g., technical feasibility, availability of resources, timely execution, budget constraints, etc.</li>
<li>Develop and maintain project management tools, including but not limited to Gantt charts, project budgets, forecasts, etc.</li>
<li>Liaise and coordinate with different departments, partner companies, and external partners to ensure that necessary resources are available to perform the required function at the planned time to achieve the project outcomes.</li>
<li>Serve as primary project contact with Sponsors to ensure that communication and reporting schedules are followed.</li>
<li>Develop site training materials including study specific materials and GCP materials.</li>
<li>Mentor and train fellow team members on FCT management.</li>
<li>Promote the organization's capabilities and values internally and externally.</li>
<li>Fulfil Monitor responsibilities within GCP and non-GCP studies, where applicable.</li>
<li>Contributing to study-level risk assessments.</li>
<li>Identifying and resolving issues at a global level.</li>
<li>Leading global study-level documentation and required tool and systems set-up.</li>
</ul>
Qualification, Training and Experience Requirements
<ul>
<li>DVM or related Life Sciences degree, accompanied by a minimum of five years of experience in Field Clinical Trials (FCT) and Project Management.</li>
<li>Ideal candidates should demonstrate industry awareness, including expertise in the pharmaceutical sector, familiarity with FDA/CVM, USDA/CVB, EMA, VICH Guidelines, Clinical Field Trials, and data quality requirements.</li>
</ul>
Important Note to Applicants
This is a remote position with potential for regular travel.
Please be aware that Internet Explorer is not compatible with BambooHire.
The Company complies with local and international data protection and privacy legislation. This includes transparency in the processing of personal information processed about job applicants during the recruitment process. By applying for this position, applicants agree to the processing of their personal data in accordance with our recruitment procedure and Privacy Notice available from our website.
As part of the hiring process, candidates need to willingly take part in personality and behaviour assessments to determine a good fit for the job role. These assessments assist with evaluation of candidates in a fair and thorough manner. All information gathered are kept private and only used to assess suitability for the job role.The Company may perform criminal and/or other relevant checks (as is relevant to the position) on all applicants applying for this position.

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