Associate Director, Clinical Quality Assurance (GCP)
Job Description
As a Clinical Operations Manager at Recursion, you will be an essential member of the Recursion Development Team. The Development Team is an empowered, execution-minded group of drug development professionals responsible for translating Recursion's innovative science to patients through clinical development activities. In this role, you will contribute to the planning and execution of one or more of Recursion’s clinical stage studies in an exciting startup environment. You will be joining a dynamic team of six and looking to grow considerably in 2023. You will make a significant day-to-day impact and be responsible for driving functional deliverables.
Responsibilities
- Lead the execution of clinical studies across diverse therapeutic areas to deliver transformative new medicines to patients
- Develop and maintain strong relationships with CROs, clinical investigators and clinical site staff
- Manage clinical operations, including CROs and reporting of start-up, conduct and close-out activities as well as diverse internal and external stakeholders relationships
- Ensure compliance with study protocol and applicable Standard Operating Procedures (SOP), Good Clinical Practices (GCP), ICHs and local regulations
- Plan and oversee project budgets, financial reporting and forecasting
Job Requirements
- Bachelor’s degree
- Interventional early phase oncology (Phase 1 and/or Phase 2) experience at a Sponsor or CRO is required
- 6+ years of experience in a clinical operations role in the biopharmaceutical industry, with at least 2+ years experience in a study manager role
Preferred: Rare disease and/or oncology experience and understanding of the patient journey in these unique patient populations. Experience at a small or midsize biotech
- Demonstrated experience organizing and leading clinical study teams
Preferred Skills: proficiency working in SmartSheet or similar project management software
- Demonstrated experience planning, initiating, conducting, and closing out phase 1 - 3 studies
- Experience in vendor and CRO selection,management, and oversight
- Experience working closely with data management and clinical teams to set up study systems and ensure quality data collection through monitoring, cleaning and analysis (phase 1-3)
Preferred: CRF development and IRT build experience, knowledge of data listings used for monitoring and cleaning, contribution to data management related plans and specification
- Strong working knowledge of FDA & ICH GCP regulations and guidelines
- Willingness and ability to travel to sites, conferences and Recursion Headquarters is required
