Senior Clinical Project Manager

Recursion•Salt Lake City, UT

3d•Hybrid

About The Position

Recursion is seeking a highly motivated, skilled, and adaptable Senior Clinical Project Manager within its Clinical Operations team. This role will lead the conduct and execution of one or more clinical trials from study start-up to study closure with support or direction from an Associate Director/Director of Clinical Operations. The Senior Clinical Project Manager will lead all aspects of clinical trial execution for one or more programs from IND through proof-of-concept and pivotal studies. This includes planning and overseeing the implementation, coordination, and execution of global clinical trials, managing study budgets, financial reporting, and forecasting in collaboration with Clinical Outsourcing. The role also involves developing and maintaining strong relationships with cross-functional study teams, CROs, clinical investigators, and clinical trial stakeholders, as well as managing clinical trial operations and leading study teams, including CROs and vendors, and reporting on start-up, conduct, and close-out activities. Ensuring compliance with study protocol and applicable Standard Operating Procedures (SOP), Good Clinical Practices (GCP), ICH, and local regulations is also a key responsibility.

Requirements

Bachelor’s degree in a scientific or healthcare-related field
8+ years of experience in a clinical operations role in the biopharmaceutical industry
At least 3+ years experience in leading clinical trials and project management 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
Excellent working knowledge of FDA, ICH, GCP regulations and guidelines

Nice To Haves

Proficiency managing timelines, tasks, milestones working in SmartSheet or similar project management software
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
CRF development and IRT build experience
Knowledge of data listings used for monitoring and cleaning
Contribution to data management related plans and specifications

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