Clinical Data Director

Director Clinical Data Management
Job Title: Director Clinical Data Management
Job Location: Berkeley Heights, NJ Hybrid
Job Type: Full-Time / Permanent
Category: Clinical Development / Clinical Data Management

The Challenge
Our client, a global biopharmaceutical organization, is seeking an experienced Director of Clinical Data Management to provide strategic and operational leadership across clinical data management activities supporting drug development programs.
This is a leadership role that still requires a hands-on clinical data management mindset. The Director will oversee critical clinical studies, lead and mentor team members, manage CRO and vendor relationships, and ensure the quality, integrity and inspection readiness of clinical databases.
The successful candidate will have extensive pharmaceutical clinical data management experience and strong hands-on knowledge of Medidata RAVE, Veeva EDC, database development, data cleaning, reconciliation and database lock. This individual will also play an important role in improving data management processes, streamlining workflows, and developing or revising SOPs.
What You'll Do
Provide strategic and operational leadership for Clinical Data Management activities across complex clinical studies.
Take ownership of a large, business-critical clinical study while remaining actively involved in study execution.
Lead, coach and mentor direct reports and other Clinical Data Management professionals.
Oversee clinical database development, data cleaning, reconciliation, medical coding and database lock activities.
Lead development and execution of Data Management Plans and Data Review Plans.
Partner with Clinical Operations, Biostatistics, Statistical Programming, Medical and other clinical-development functions.
Provide oversight of CROs and external data-management vendors from study startup through database lock.
Oversee external data reconciliation, including laboratory, safety/SAE and other vendor data.
Support eCRF design and ensure clinical databases capture the appropriate information for downstream analysis.
Drive continuous improvement initiatives across Clinical Data Management processes and systems.
Develop, revise and implement SOPs, work instructions and best-practice documentation.
Identify opportunities to streamline clinical data systems, processes and workflows.
Support regulatory submissions and maintain audit and inspection readiness.
Evaluate and help select Clinical Data Management systems, technologies and external vendors.
Ensure compliance with applicable regulatory requirements and clinical data standards.
What You'll Bring
Bachelor's degree or higher in a scientific, healthcare or related discipline.
10+ years of progressively responsible Clinical Data Management experience within pharmaceutical, biotechnology, CRO or a related regulated environment.
Demonstrated experience leading clinical studies from startup through database lock.
Strong recent experience with Medidata RAVE and Veeva EDC.
Significant hands-on experience with clinical database builds and database development.
Previous experience managing, coaching and developing direct reports.
Ability and willingness to remain hands-on while operating at the Director level.
Strong CRO and clinical data vendor-management experience.
Strong understanding of EDC systems and related clinical-data technologies.
Knowledge of ICH, CDASH, CDISC, 21 CFR Part 11, FDA and other applicable regulatory requirements.
Experience supporting regulatory submissions, audits and inspections.
Demonstrated success improving processes, streamlining workflows and developing or updating SOPs.
Excellent communication, leadership, stakeholder-management and influencing skills.
Strong ability to operate within a fast-paced, cross-functional and matrixed environment.
Preferred Qualifications
5+ years of experience with Medidata RAVE, including EDC and related RAVE functionality.
Experience with IWRS, imaging, ePRO/eCOA and other clinical-data technologies.
Experience with data visualization/reporting tools such as Spotfire, J-Review or Business Objects.
Knowledge of GxP, Annex 11, GDPR and GAMP.
Experience applying risk-based approaches to clinical data management and process improvement.
Work Environment
Hybrid position based in Warren, NJ. Candidates should be available onsite every Wednesday, as well as Tuesday through Thursday approximately every six weeks for departmental meetings. Local New Jersey/tri-state candidates are strongly preferred; candidates elsewhere in the tri-state area may be considered if they can reliably meet the onsite requirements.
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