Principal responsibilities will include:
? Performs trial level oversight controls as described in the oversight plan, Quality Control (QC)
process and work instructions with minimal Data Delivery Lead (DDL) direction.
? Reviews clinical data management documents ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency. Ensures compliance with regulatory guidelines and the documentation matrix.
? Ensures real-time inspection readiness of all Data Delivery (DD) deliverables for the trial; Participate in Regulatory Agency and J&J internal audits as necessary.
? Plans and tracks content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival. Ensures deliverables are on time.
? Takes a leadership role with the assigned clinical working group(s) to ensure that DD and TA trial needs and deliverables are met.
? Identifies and communicates lessons learned, best practices and frequently asked questions at the trial level.
? Identifies and participates in process, system, and tool improvement initiatives within DD.
? Presents and trains at investigator and monitor meetings.
- A minimum of a BS/BA degree or professional experience equivalent.
- Minimum of 3 years Clinical Data Management experience.
- Experience with any of the following Therapeutic Areas preferred: Oncology, Neuroscience, Immunology, Cardiovascular, Metabolics, Infectious Diseases, Vaccines.
- Electronic Data Capture (Medidata RAVE, Inform) platforms preferred
- Experience in clinical drug development within the pharmaceutical industry or related industry.
- SAS experience is desired
- Vendor oversight experience is desired.
- Team leadership experience is desired.
- Project management experience is desired.
Requisition ID: 5498170707