Remote Study Start-Up Manager
- New York, NY
The Study Start-Up Manager will own key deliverables on the clients late-stage clinical trials and serve as a primary point of contact interfacing between functional groups, investigator sites and vendors. The Associate Director, Clinical Operations will report to the Head of Clinical Operations.
- Under direct supervision of the Head of Clinical Operations, manage the start-up and execution of clinical trials
- Assist with creating/issuing RFPs and selection and start-up of study vendors (central labs, study supplies, central readers, safety database, licensure for PROs, etc.)
- Manage vendor relationships to ensure appropriate scope of work and oversight to achieve study start-up milestones within agreed upon timelines, budget and quality parameters
- Contribute to the development, review and approval of study documents, study plans and budgets.
- Work closely with all functional area leads on development and review of vendor clinical documents, systems builds and study plans (Project Management Plan, Clinical Study Plan, Case Report Forms, Data Management Plan, EDC and IXRS builds, etc.)
- Assist with the preparation and review of required study and regulatory documentation, e.g., master and country-specific informed consents, Monitoring Plan, Pharmacy Manual, investigator site contracts and budgets
- >5 years of clinical research experience, at least 3 of which should be in a leading role accountable for the planning and execution of global clinical trials
- Bachelor’s degree or higher in a discipline related to clinical practice/health care, life sciences, or drug development
- Experience in a small biotech or working on a small cross-functional team preferred
- Phase 3 and global trial experience preferred
- Hands-on, roll-up-your-sleeves approach, with a high sense of urgency and drive to achieve study milestones in a fast-paced environment
Thursday, September 30, 2021