Associate Director, Clinical Data Management

The role

The Associate Director, Clinical Data Management leads clinical data management activities across clinical programs. This person oversees CRO performance, database design, and data cleaning from study start-up through database lock.

What you will do

• Oversee development and review of data management study documents
• Oversee EDC and clinical data systems build, testing, and database lock
• Monitor clinical data quality, study metrics, and KPIs
• Communicate study status and risks to cross-functional study teams
• Ensure compliance with ICH E6(R3) GCP, 21 CFR, and global regulatory requirements
• Contribute to process improvement initiatives and SOP development
• Support preparation for regulatory inspections and audits
• Maintain documentation in the Trial Master File

Required qualifications

• Bachelor’s degree in Life Sciences, Health Sciences, Computer Science, or a related discipline, or equivalent education and experience
• Minimum of 7 years of progressive experience in clinical data management within the pharmaceutical, biotechnology, or CRO industry
• Proven experience managing CDM activities across all phases of clinical development (Phase I–III)
• Prior experience managing CRO relationships and overseeing outsourced CDM activities
• Proficiency with EDC platforms (e.g., Medidata Rave, Veeva Vault EDC)
• Proficiency with CDISC (CDASH/SDTM/ADaM) standards
• Working knowledge of data cleaning, query management, and database lock processes
• Proficiency in medical coding dictionaries (MedDRA, WHO Drug) and coding conventions
• Familiarity with centralized data review methodologies and risk-based monitoring (RBM) approaches
• Ability to lead cross-functional study teams and manage CRO performance
• Strong written and verbal communication
• Ability to present data management status and risks to program leadership

Nice to have

• Experience in immunology or autoimmune therapeutic areas

Benefits

• Competitive health and wellness coverage
• Paid time off
• Public holidays
• Additional leave entitlements in accordance with local requirements
• Flexible work arrangements / hybrid schedule

About the company

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases.