What are the responsibilities and job description for the Director, Clinical Data Management Consultant position at Kaye/Bassman International?
Duration: 6-12 Month Contract with Potential for Full-Time Conversion
Full-Time Contract Role: (40 hours/week)
I am currently leading a search for an experienced Director-level Clinical Data Management Consultant to support a growing biotech with an innovative, late-stage pipeline.
This role will play a critical part in strengthening internal data management capabilities while collaborating with Clinical Operations, Biostatistics, Pharmacovigilance, Regulatory, and external CRO partners to support ongoing and future clinical studies.
Key Responsibilities:
- Lead EDC build and CRF implementation in Medidata Rave (internalizing core data collection from CRO).
- Oversee SDTM configuration and formatting aligned with annotated CRFs and regulatory data specifications.
- Standardize study monitoring reports and data management metrics directly from EDC.
- Support the integration of pharmacovigilance data streams for signal detection and regulatory needs.
- Provide global CRO oversight of data management activities.
- Manage database lifecycle (freeze, lock, archiving) across active and prospective studies.
- Development of data pipelines for prospective studies (European Safety Study and confirmatory study in 1-3 indications).
Qualifications:
- Director-level expertise in global clinical Data Management.
- Strong hands-on experience with Electronic Data Capture (EDC) systems, particularly Medidata Rave.
- Deep expertise in Electronic Data Capture systems.
- Advanced CDISC SDTM and ADaM knowledge.
- SAS proficiency; JMP, R, or Python a plus.
- ePRO experience.
- French fluency (verbal and written) is highly preferred.