Associate Director, Data Management

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Provide strategic direction and oversight for data management operations across various clinical programs, ensuring the delivery of high-quality, inspection-ready data.

• Lead and mentor data management personnel while promoting teamwork among internal teams and external collaborators, including CROs and vendors.

• Manage the complete data management lifecycle, which encompasses study initiation, database construction, data evaluation, and database locking.

• Facilitate vendor management, study implementation, and cross-functional collaboration to guarantee adherence to timelines, budgets, and quality standards.

• Develop and refine data management standards, SOPs, and procedures to ensure alignment with GCP, ICH, and regulatory guidelines.

• Offer strategic insights into resource allocation, budgeting, and ongoing improvement initiatives within the department.

⛳️ Requirements

• Bachelor’s degree (or higher) in life sciences, mathematics, or a related discipline.

• Over 10 years of clinical data management experience in biotech, pharmaceutical, or CRO settings.

• Proven experience managing multiple studies and/or programs, including vendor management.

• Prior experience in people management is highly preferred.

• Experience leading a Phase 3 trial and engaging with Health Authorities or readiness for such interactions.

• In-depth knowledge of GCP, ICH directives, FDA regulations, and clinical data standards.

• Familiarity with EDC systems (e.g., Veeva, Medidata RAVE) and CDISC standards (CDASH, SDTM, ADaM).

• Proficient in using data visualization and query tools.

• Strong leadership, strategic thinking, and problem-solving capabilities.

• Exceptional communication and cross-functional collaboration skills.

• Demonstrated ability to leverage AI tools in daily tasks; baseline proficiency is expected, and advanced or innovative applications of AI are highly valued.

🏝️ Benefits

• Annual target bonus

• Equity

• Comprehensive suite of competitive benefits aimed at supporting employees' overall well-being