Clash
of Jobs
Browse All Jobs
Job Description
Recursion Pharmaceuticals is seeking a Manager of Clinical Data Management to lead and oversee end-to-end Clinical Data Management activities on assigned studies and programs. The Manager will play a critical role in the management of all 3rd party data sources and serve as a Subject Matter Expert (SME) for Data Management. They will collaborate on clinical development initiatives with cross-functional groups within the larger Data Science teams at Recursion.
Responsibilities:
- Lead End to End Data Management activities with hands on ability to manage outsourced studies and lead DM and external vendor oversight activities and deliverables.
- Proficiency in project management leading 2-3 outsourced programs, simultaneously.
- Represent Data Management function in Clinical Study Meetings, ensuring proactive alignment of expectations between the CRO and Recursion regarding all data-related deliverables.
- Works with CRO and Recursion functional groups to complete EDC set up and other systems such as IRT, ePRO etc.,
- Establish Vendor Oversight Plans for all studies and responsible for Vendor Data Quality Reviews and Oversight.
- Serve as a SME for various operational activities and DM processes like EDC, External data standardization, Collection, and Processing.
- Lead the efforts with Biometrics and Clin Dev organizations for creation and standardization of CRF’s Data Review Plans etc.
- Leads/Oversee the creation and maintenance of Data Management documents including, but not limited to, CDMP, CCG’s, Data Review Plans, edit checks, Listing review checks, Data Integrations specs, Data Transfer Specs, External Data Reconciliation plans, SAE Reconciliation Guidelines, Coding Guidelines, Database Lock, Checklists and Plans.
- Accountable for coordination with other functional groups for submission related activities.
- Manage strategic input into the design of data flow across EDC and non-EDC data sources across vendor networks.
- Ensure Filing, archival and inspection readiness of all Data Management Trial Master File (TMF) activities.
- Review and manage external Data Management Budgets, ensure accuracy, and understand trends to support Budget planning and forecasting.
Requirements:
- Bachelor’s degree in science, math or computer science
- 8 - 12+ years’ experience in the biopharmaceutical industry.
- Experience managing external data and 3rd party vendors is a must.
- Strong knowledge of regulations and guidelines that apply to the conduct of clinical trials
- Excellent written and verbal communication skills and ability to work collaboratively as a part of a team
Recursion offers:
- This position can be based at any of our offices in Salt Lake City / New York City / Toronto / London / Oxford.
- Hybrid work environment
- Relocation support can be provided for this role.
- Annual bonus and equity compensation
- Comprehensive benefits package
