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Clinical Trial Oversight Manager
2 months ago
Position Overview
The Senior Clinical Operations Associate will collaborate closely with the Head of Clinical Operations to facilitate the effective management and oversight of clinical trials. This role involves ensuring the integrity of trial execution and data collection while working in partnership with key study sites and investigators. The Senior Associate will also engage with various departments, including Clinical Development, Supply Chain, Regulatory Affairs, and Project Management, to promote cross-functional synergy.
Key Responsibilities
- Oversee all facets of clinical trials to guarantee timely completion, adherence to budgetary constraints, and compliance with established SOPs, FDA regulations, and ICH/GCP standards.
- Manage critical study parameters such as initiation activities, participant enrollment, site oversight, data collection, and analysis, while proactively addressing challenges within the clinical team.
- Draft and evaluate essential documents including informed consent forms, case report forms, and study manuals.
- Assist in the selection and management of clinical study sites, ensuring alignment with project goals.
- Evaluate and oversee CROs and other vendors, including contract negotiation and budget management.
- Contribute to project objectives and ensure alignment with timelines and deliverables.
- Provide regular updates to the cross-functional operations team regarding study progress.
- Analyze issues related to investigational sites and CROs, developing actionable plans for resolution.
- Support the creation of study-specific tools and manuals to enhance data quality and standardization.
- Facilitate training for new team members on study protocols as necessary.
- Track and maintain study metrics, providing updates to the team.
- Act as the primary sponsor contact for study sites.
- Engage in the analysis and reporting of safety and patient care issues, as well as study design and conduct challenges.
- Review and negotiate contracts and budgets with clinical study sites.
- Coordinate and present at Investigator Meetings and CRO Training sessions as required.
- Participate in site qualification, initiation, monitoring, and close-out visits, including oversight of CRO site monitors.
- Support internal and regulatory audits of clinical trial sites and vendors, assisting in the resolution of audit findings.
Qualifications and Experience
- Bachelor's degree in a scientific or health-related discipline.
- A minimum of 2 years of experience as a Clinical Research Associate in a biopharmaceutical organization or CRO.
- Prior experience with oncology clinical trials is highly desirable.
- Experience in early development trials is an advantage.
- Expertise in radiopharmaceuticals is a significant plus.
Essential Skills
- In-depth knowledge of FDA regulatory requirements and ICH/GCP guidelines.
- Proven ability to implement, monitor, and manage clinical trials from initiation to completion.
- Strong organizational skills with the capacity to prioritize and manage multiple tasks.
- Excellent verbal and written communication abilities.
- Demonstrated problem-solving and negotiation skills.
- Ability to work collaboratively as part of a team.
- Willingness to travel as project needs dictate.
- Proficient in Microsoft Office Suite and clinical trial databases.
