Director, Clinical Data Management Consultant

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. #J-18808-Ljbffr Kaye/Bassman International