The Clinical Study Manager is responsible for the day to day management of global clinical trials and will manage the study management team, vendors, clinical monitors and clinical trial sites. The majority of time will be spent managing Phase III multinational, multicenter pediatric clinical trials, with some possible management of early phase development studies (phase I/II studies). This position will work closely with a cross-functional team based in the US and EU to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP Country specific regulatory guidelines, company goals, and budgets. This position is responsible for ensuring achievement of his/her own or others’ project goals and objectives. This person is a capable manager with the ability to perform or manage the duties and functions necessary to deliver a quality study on time and within budget.
- Participates in and facilitates CRO/vendor selection process for outsourced activities including the request for proposal (RFP) process.
- Point of responsibility for oversight of CRO managing clinical studies in the region. Oversees site start up, subject recruitment, enrollment, study management, monitoring, site management, clinical trial master files, and data clean up.
- Participation in CRF design, project plans and clinical report writing.
- Proactively identifies potential study issues/risks and recommends/implements solutions.
- Manage study related activities including timelines, study visits, site selection, site initiation, site management, study drug management and closeout activities.
- Develops reviews and approves regulatory and other required study documents for GCP compliance for US, EU and other parts of the world.
- Manage ongoing communication of operation issues and provide accurate progress reports on assigned activities to study team.
- Responsible for managing site and/or vendor budget activities.
- Contributes to projects that support wider organizational goals.
- Bachelors degree or equivalent required (scientific or healthcare discipline preferred)
- 7+ years study management experience in clinical and drug development
- Experience in managing CROs, specialty labs and outside vendors in global, multinational Phase 3 program
- Experience in Phase III study start-up, data cleaning, and close out in the United States and European countries
- Extensive experience in planning, risk mitigation, trial budgets, site selection, clinical supplies management, bio sample management, conduct and monitoring of clinical studies
- Working knowledge of ICH GCP guidelines
- Excellent planning and organizational skills
- High level of initiative and ability to work independently
- Experience overseeing and managing a Trial Master File (for phase I-IV)
- Experienced in managing early development phase clinical studies
- Demonstrated experience in pediatric epilepsy (CNS) or other therapeutic areas
- 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 with strong analytical and problem solving skills
- Knowledge of EU Country regulations and experience developing EU country specific informed consents
Special Working Conditions
- Ability to travel as required
Location/Region: Emeryville, CA (US - 94608)