Clinical Operations Manager
2 days ago
CPC Clinical Research is seeking a highly skilled Clinical Operations Manager to oversee the day-to-day operations of our clinical trials. As a Clinical Operations Manager, you will be responsible for ensuring the overall quality of project services and deliverables, as well as developing and implementing systems to standardize and improve project management practices.
Key Responsibilities:- Work closely with the Head of Research and Community Health Operations and Head of Endpoint and Specialty Services to ensure overall quality of project services, proactive issue resolution, and development of systems to standardize and improve project management practices.
- Serve as a mentor to other Clinical Operations Managers, including providing guidance on what efforts and activities are required to ensure the overall quality of project services and deliverables.
- Oversee clinical operations management activities when delegated to a Clinical Trial Manager (CTM). For single-site or smaller multi-center studies in which these activities are not delegated to a CTM:
- Manage site identification, evaluation, initiation, contracting/budget negotiation, and site monitoring processes as required by contract.
- Identify the required regulatory documents for investigational product (IP) release and oversee documents collection.
- Prepare central IRB submissions; oversee site IRB approvals and ensure collection of all new or expiring Investigator regulatory documents after site activation.
- Oversee the development of project-specific essential documents for site oversight and development of site materials.
- Review and finalize monitoring visit reports and follow-up letters with Clinical Research Associates (CRAs).
- Work with CRAs on overall site management including identification, and resolution of site related compliance issues.
- Prepare study enrollment reports and review site issues with the project team.
- Manage and approve site payments as applicable.
- A Nursing or BA/BS in a scientific field (or equivalent knowledge/experience).
- 5 years of experience in a clinical research setting (required).
- 3 years of sponsor or CRO clinical research project/clinical operations management experience.
- Demonstrated ability to successfully execute all aspects of sponsor/CRO clinical trial management, as well as the ability to mentor and oversee the activities of other COMs.
- Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials.
- Proficiency in Microsoft Office, particularly Outlook, Word, and Excel.
- Excellent communication and organizational skills.
- Great attention to detail.
- Exemplary skills leading and managing multi-disciplinary teams in a clinical research setting.
- Ability to organize, instruct, and supervise staff, while promoting group effort and achievement.
- Ability to adapt quickly to new situations, manage conflicts, and resolve problems effectively.
- Willingness to travel 20-25%.
CPC Clinical Research offers a comprehensive benefits package, including medical, dental, vision, life, STD, LTD, and a matching 401(k) plan. We also offer 11 paid holidays, 15-25 vacation days based on years of service, and paid sick time. Our company culture values flexibility and remote work, with a focus on work-life balance.
CPC Clinical Research is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and respectful work environment that values diversity, equity, and inclusion.
Apply now to join our team and take the first step towards a rewarding career in clinical research
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