Overview
The Senior Clinical Data Manager will oversee the end-to-end clinical data strategy for clinical trials, ensuring quality and compliance through effective vendor management and cross-functional collaboration. Working closely with teams in Biostatistics, Data Science, and Clinical Operations, the manager will leverage modern electronic data capture (EDC) platforms to enhance data innovation across studies. This is a six-month contract role offering a flexible working arrangement of two to three days a week on-site.
Responsibilities
- Lead the entire data lifecycle from CRF/database design to database lock.
- Oversee third-party data vendors and manage Data Transfer Agreements (DTAs).
- Collaborate with Biostatistics, Data Science, and Clinical Operations teams.
- Implement risk-based monitoring and standardize data flows according to CDISC/SDTM standards.
Requirements
- Minimum of 5 years experience in Clinical Data Management or 3+ years with a Master’s degree.
- Hands-on experience with EDC platforms such as Medidata RAVE or InForm.
- Strong understanding of non-CRF data streams, including ePRO, IRT, and labs.
- Experience in vendor management and oversight.
- Basic coding skills in SAS, R, or Python is a plus.