Associate Director, Data Manager

Role: Associate Director, Clinical Data Management, leading data activities for global early- and late-phase clinical trials in biopharma, with a focus on genetic medicines utilizing RNA editing platforms.

Responsibilities

• Oversee end-to-end data management from study start-up to database lock, including CRO/vendor oversight, database design, data cleaning, and ensuring regulatory compliance (GxP, 21 CFR Part 11, ICH, GCDMP).
• Collaborate with cross-functional teams (Clinical Development, Biostatistics, Regulatory, Operations) to ensure data quality, integrity, and audit readiness, contributing to regulatory submissions.
• Manage data system configurations, transfer protocols, and validation activities, with a strong emphasis on data quality, metrics, and inspection preparedness.

Qualifications

• Bachelor's in Life Sciences or related field;
• 8+ years in clinical data management, with experience managing CRO relationships and overseeing outsourced activities in Phase I-IV trials.
• Technical expertise in EDC platforms (e.g., Medidata Rave), data standards (CDISC), and familiarity with advanced data analytics, RBM, and AI-enabled tools.
• Strong communication, risk mitigation, and leadership skills in a fast-paced, innovative environment.

High-Value

Experience with complex, regulated clinical trials in genetic or nucleic acid-based therapeutics, with an emphasis on data quality, regulatory compliance, and cross-functional collaboration.