Associate Director, Clinical Data Management

About the role

Beeline Medicines is seeking an Associate Director to lead Clinical Data Management across one or more clinical programs. The role ensures timely delivery of high‑quality, audit‑ready trial data to support regulatory submissions and development timelines.

Key responsibilities

• Develop and review data management study documents, including Data Management Plans, CRF/eCRF design specifications, validation plans, and data cleaning plans.
• Oversee EDC and other clinical data system builds, user acceptance testing, database releases, mid‑study updates, interim snapshots and database lock activities.
• Monitor data quality, study metrics and KPIs, managing discrepancy resolution, medical coding (MedDRA, WHO Drug) and reconciliation of external data sources such as central labs, eCOA and safety data.
• Manage CRO and vendor performance, ensuring alignment with study milestones and inspection‑readiness standards.
• Partner with Biostatistics, Statistical Programming, Clinical Operations, Clinical Development, Pharmacovigilance and Quality teams to synchronize deliverables.

Required profile

• Proven experience leading clinical data management for multiple clinical programs.
• Strong ability to oversee CRO and vendor activities and ensure data integrity.
• Demonstrated collaboration with cross‑functional teams including Biostatistics, Clinical Operations and Pharmacovigilance.
• Experience delivering audit‑ready data for regulatory submissions.

Required skills

• Electronic Data Capture (EDC) systems
• CRF/eCRF design and specification
• Data validation and cleaning methodologies
• Medical coding using MedDRA and WHO Drug dictionaries
• Data reconciliation from central labs, eCOA and safety databases
• User Acceptance Testing (UAT) and database release management