Associate Director, Clinical Data Management

About the role

The Associate Director, Clinical Data Management leads data management activities across multiple clinical programs, ensuring high‑quality, audit‑ready data for regulatory submissions. This remote position collaborates closely with cross‑functional teams and external vendors to meet study milestones and inspection‑readiness standards.

Key responsibilities

• Oversee development and review of data management plans, CRF/eCRF designs, validation plans, and data cleaning strategies.
• Manage EDC system builds, user acceptance testing, database releases, interim snapshots, and lock activities.
• Monitor data quality, KPIs, discrepancy management, medical coding, and reconciliation of external data sources.
• Ensure compliance with ICH GCP, 21 CFR Parts 11/312, GDPR, HIPAA, and other regulatory requirements.

Required profile

• Bachelor’s degree in Life Sciences, Health Sciences, Computer Science, or related field.
• Minimum 7 years of progressive clinical data management experience in pharma/biotech/CRO.
• Experience managing CDM across Phase I‑III trials, including late‑stage and registration studies.
• Proven ability to lead cross‑functional teams and manage CRO relationships without direct authority.

Required skills

• Proficiency with EDC platforms such as Medidata Rave and Veeva Vault EDC.
• Strong knowledge of CDISC standards (CDASH, SDTM, ADaM).
• Expertise in medical coding dictionaries (MedDRA, WHO Drug).
• Hands‑on experience with data cleaning, query management, database lock processes, and risk‑based monitoring.

What we offer

• Competitive salary range $181,000 – $235,000 USD.
• Potential discretionary annual bonus and long‑term equity awards.
• Comprehensive benefits package tailored to local regulations, including health coverage and flexible work arrangements.