Senior Clinical Project Manager
| Company | Recursion Pharmaceuticals |
|---|---|
| Location | Salt Lake City, UT, USA, New York, NY, USA |
| Salary | $168000 – $204800 |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior, Expert or higher |
Requirements
- Bachelor’s degree in a scientific or healthcare-related field
- 7+ years of experience in a clinical operations role in the biopharmaceutical industry, with at least 3+ years experience in a clinical project management role within a biotech organization required
- Early phase (Phase 1, 2) oncology experience at a biotech/Sponsor is required
- Demonstrated experience organizing and leading clinical study teams
- Demonstrated track-record of efficient and effective clinical trial planning and execution, including risk management and mitigation strategies
- Experience in vendor and CRO selection, management, and oversight
- Experience managing and tracking study budgets and financials with participation and involvement with invoice and contract review and approvals
- Experience working closely with data management and clinical teams to set up study systems and ensure quality data collection through monitoring, cleaning and analysis
- Excellent working knowledge of FDA, ICH, GCP regulations and guidelines
- Willingness and ability to travel to sites, conferences and Recursion offices as needed
Responsibilities
- Lead all aspects of clinical trial execution for one or more programs from IND through proof-of-concept and pivotal studies
- Plan and oversee implementation, coordination, and execution of global clinical trials including, but not limited to, oversight of study budgets, financial reporting, and forecasting in collaboration with Clinical Outsourcing
- Develop and maintain strong relationships with cross-functional study teams, CROs, clinical investigators, and clinical trial stakeholders
- Manage clinical trial operations and lead study teams, including CROs and vendors, and reporting of start-up, conduct, and close-out activities
- Ensure compliance with study protocol and applicable Standard Operating Procedures (SOP), Good Clinical Practices (GCP), ICH and local regulations
Preferred Qualifications
- Preferred Skills: proficiency managing timelines, tasks, milestones working in SmartSheet or similar project management software
- Preferred: CRF development and IRT build experience, knowledge of data listings used for monitoring and cleaning, contribution to data management related plans and specifications