Job Description
Recursion Pharmaceuticals is seeking an Associate Director of Clinical Data Management to lead and oversee end-to-end Clinical Data Management activities on assigned studies and programs. The Associate Director 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 be responsible for leading and delivering initiatives for CDM within the Biometrics group and will collaborate with cross-functional groups within the Clinical Development organization and larger Data Science teams at Recursion.
- Lead End to End Data Management activities.
- Manage outsourced studies and lead DM and external vendor oversight activities and deliverables.
- Represent Data Management function in Clinical Study Meetings.
- Work 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.
- Lead/Oversee the creation and maintenance of Data Management documents.
- Coordinate with vendors to guarantee that data collection is compatible with clinical databases and meets SDTM requirements.
- 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.
- Support the development of Clinical Data Management Standard Operating Procedures and Work Instructions.
- Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and CDM guidance documents.
- Bachelor’s degree in science, math or computer science
- 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.
- Annual bonus and equity compensation
- Comprehensive benefits package
- Relocation support