Vacancy expired!
- Lead cross-functional teams to ensure studies are conducted one time, with quality and within budget
- Develop and maintain study timelines through collaboration with internal and external stakeholders; ensure timelines remain on track through ongoing communication, collaboration and risk-mitigation strategies
- Drive study start-up activities, including site and vendor identification, feasibility and selection
- Effectively model and manage patient enrollment forecasts; implement risk mitigation strategies to ensure enrollment remains on track
- Develop oversight plans for outsourced services; oversee vendors, including CROs, third-party vendors and consultants to ensure the timeliness and quality of services performed
- Oversee the management of the electronic Trial Master File (TMF); ensure the TMF is created, maintained, monitored and closed out in accordance with the TMF plan and study timelines.
- Collaborate with medical research, data management, biostatistics, pharmacovigilance, and other functions to ensure data is processed in a timely manner for ongoing data review, interim analyses and final database lock.
- Contribute to the writing and review of clinical documents such as protocols, informed consents, investigator brochures, DSURs, monitoring plans and reports.
- At least five (8) years in trial management with a sponsor company managing various phases of clinical trials.
- BA or higher
- Experience overseeing vendors, including identification and mitigation of risks.
- Experience leading cross-functional teams and meetings.
Vacancy expired!