Associate Director of Clinical Data Management
Posted 2 months ago Expired
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Lead and oversee end-to-end clinical data management activities for assigned studies and programs, managing third party data sources and serving as a subject matter expert. Drive initiatives for Clinical Data Management within the Biometrics group, collaborating cross-functionally and ensuring compliance with regulatory guidelines.
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
- Represent Data Management function in Clinical Study Meetings, ensuring proactive alignment of expectations between the CRO and Recursion regarding all data-related deliverables
- Work with CRO and Recursion functional groups to complete EDC set up, database migrations /UAT and other systems such as IRT, ePRO
- 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/Oversee the creation and maintenance of Data Management documents including, but not limited to, CDMP, CCG’s, Data Review Plans
- 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
Requirements
- 12+ years’ experience in the biopharmaceutical industry
- Experience managing external data and 3rd party vendors
- 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
Qualifications
- Bachelor’s degree in science, math or computer science
- 12+ years’ experience in the biopharmaceutical industry
Skills
* Required skills
Benefits
About BioSpace
Lilly is a global healthcare leader headquartered in Indianapolis, Indiana, specializing in discovering and bringing life-changing medicines to patients worldwide. They are investing over $1 billion to create a new state-of-the-art manufacturing site in Concord, NC, focusing on parenteral medication...