Director, Clinical Data Management Consultant (Basking Ridge)

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.