Associate Director, Clinical Data Management

Contact: Terra Parsons -

teamnt@penfieldsearch.com

No 3rd party candidates

Associate Director Clinical Data Management
Remote | Contract

We are partnering with a growing biotech organization seeking an Associate Director of Clinical Data Management to lead Phase III clinical programs, oversee CROs and vendors, and provide hands-on data management expertise. This person will lead the Clinical Data Management response to an upcoming inspection and mentor Data Managers while ensuring high-quality, timely, and inspection-ready data across assigned programs.

Key Responsibilities

• Lead clinical data management strategy and execution across assigned programs, from study startup through database lock and close-out, with accountability for program priorities, timelines, risks, and data quality.
• Provide program-level oversight of CROs and vendors, setting clear expectations, reviewing deliverables and performance, and resolving or escalating issues that affect timelines, quality, or compliance.
• Lead Clinical Data Management preparation and execution for an upcoming regulatory inspection, in partnership with Quality Assurance and other functions. Coordinate documentation, prepare team members, manage data management requests, and support inspection responses and follow-up actions.
• Serve as the Clinical Data Management subject matter expert during inspection activities, explaining study processes, data integrity controls, vendor oversight, and key decisions to inspectors as needed.
• Mentor and coach Data Managers on study ownership, CRO oversight, data review, issue resolution, and inspection readiness; provide technical guidance and review key deliverables.
• Partner with Clinical Operations, Biostatistics, Statistical Programming, Medical, Safety, and Quality Assurance to align program data strategies, review priorities, and resolve cross-functional issues.
• Oversee and contribute hands-on to Data Management Plans, eCRF design and completion guidelines, edit checks and query logic, User Acceptance Testing, data review plans, and data cleaning processes.
• Direct ongoing data review, query management, and safety and external data reconciliation to ensure data integrity, consistency, traceability, and readiness for database lock.
• Identify program-level data risks early, recommend practical mitigation plans, and communicate status and decisions clearly to stakeholders.
• Drive fit-for-purpose SOPs, data standards, reporting enhancements, and process improvements that strengthen consistency and inspection readiness in a growing biotech environment.

Qualifications

• Bachelor’s degree in a scientific, technical, or clinical discipline; an advanced degree is a plus.
  Typically 8–10+ years of clinical data management experience within biotechnology, pharmaceutical, or CRO environments, including program leadership and substantial CRO/vendor oversight.
• Regulatory inspection experience is required. Candidates with extensive, hands-on inspection readiness experience may also be considered. Direct interaction with inspectors, including presenting or explaining Clinical Data Management processes and responding to questions, is strongly preferred.
• Demonstrated ability to lead Clinical Data Management inspection activities, coordinate documentation and responses, and maintain inspection-ready processes and records.
• Experience leading data management across programs or multiple studies, with ownership of timelines, priorities, risks, and cross-functional communication.
• Experience mentoring and developing Data Managers and providing technical leadership to internal and external teams.
• Strong Phase III clinical trial experience, including oversight of complex data cleaning, reconciliation, and database lock activities; CNS experience is a plus.
• Strong hands-on experience reviewing and interrogating clinical trial data and overseeing activities from startup through database lock.
• Experience with EDC systems such as Medidata Rave, Oracle, or Veeva.
• Working knowledge of CDISC standards, including SDTM and downstream ADaM usage, and clinical data dictionaries including MedDRA and WHODrug.
• Sound knowledge of applicable GCP and regulatory expectations for clinical data management, data integrity, documentation, and vendor oversight.
• Strong critical thinking, problem-solving, and communication skills, with the ability to work independently, influence cross-functional partners, and make practical recommendations.
• Resourceful, proactive, detail-oriented, and comfortable balancing strategic leadership with hands-on execution in a dynamic biotech environment.