Clinical Trial Manager
Location: Emeryville, CA
Department: Clinical Development - Fintepla
The Clinical Trial Manager (CTM) is responsible for the day to day management of clinical trials, vendors, and clinical trial sites. This position will work closely with cross-functional teams to ensure that clinical trials are conducted in a manner compliant with SOPs, ICH/GCP Country specific regulatory guidelines, company goals, timelines and budgets. This position is responsible for ensuring achievement of his/her own project goals and objectives. This person is a capable manager with the ability to perform and manage the duties and functions necessary to deliver a quality study on time and within budget.
- Participates in CRO/vendor selection process for outsourced
- Oversees vendor activities to include reviewing monitor visit reports, participating in vendor meetings, supporting development/management of vendor oversight plans/trackers, identifying and mitigating/escalating issues/risks as appropriate.
- May be a point of responsibility for oversight of CRO and additional vendors.
- Manages/oversees site start up, subject recruitment, enrollment, study management, monitoring, site management, clinical trial master files, and data clean
- Participates in CRF design, project plans and clinical report
- Proactively identifies potential study issues/risks and recommends/implements
- Supports the management of study related activities including timelines, study visits, site selection, site initiation, site management, study drug management, closeout activities, development/management of trackers, data sharing forums.
- Assists in the development/review and approves regulatory and other required study documents for GCP compliance for US, EU and other parts of the
- Manages ongoing communication of operation issues and provide accurate progress reports on assigned activities to study
- May be responsible for managing/overseeing site and/or vendor budget
- Participates in/manages quality data cleaning activities such as data listing reviews, TMF reviews.
- Participates in/facilitates project team discussions/meetings.
- Leads and/or participates in quality improvement and process improvement initiatives.
- Other duties as assigned.
- Manages ambiguity
- Action oriented
- Plans and aligns
- Bachelors degree or equivalent required (scientific or healthcare discipline preferred)
- 5+ years study management (or equivalent) experience in clinical and drug development
- Experienced in managing CROs, specialty labs and outside vendors
- Experience in start-up, data cleaning, and close out
- Working knowledge of ICH GCP guidelines
- Excellent planning and organizational skills
- High level of initiative and ability to work independently
- Excellent written and verbal communication skills
- Possess excellent interpersonal skills
- Proficiency with MS Word, Excel, Outlook, Project and PowerPoint
- Demonstrated creativity and innovation to support projects and initiatives
- Attention to detail
- Knowledge of EU Country regulations and experience developing EU country specific informed consents
Special Working Conditions
- Ability to travel as required