Senior Manager, Clinical Data Management

Responsibilities

• Lead Data Management activities across assigned clinical studies and programs
• Serve as the primary sponsor-side Data Management lead and key point of contact for CROs and vendors
• Oversee the development and review of Data Management Plans (DMPs), CRFs/eCRFs, and edit check specifications
• Facilitate User Acceptance Testing (UAT) for database builds and migrations
• Monitor vendor performance, timelines, and quality metrics
• Ensure data integrity, traceability, and compliance with ICH-GCP and regulatory requirements
• Partner with Clinical Operations, Biostatistics, and Regulatory Affairs to drive study success

Requirements

• Bachelor's degree in Life Sciences, Health Sciences, Computer Science, or a related field
• 8+ years of progressive Clinical Data Management experience in biotech, pharma, or CRO
• 3+ years of experience as a Data Management Lead overseeing outsourced clinical trials
• Proficiency with Medidata Rave EDC
• Working knowledge of CDISC standards (SDTM and CDASH)
• Experience supporting regulatory inspections and audits

Preferred Qualifications

• Experience in CNS, psychiatry, or neuroscience therapeutic areas
• Experience with ePRO/eCOA, IRT/RTSM, and laboratory integrations
• Medidata Rave certification
• Experience with data visualization tools like Spotfire, Power BI, or Tableau
• Knowledge of data programming tools such as SQL, R, or Python
• Experience supporting NDA, BLA, or MAA regulatory submissions

About the Company

Definium Therapeutics is a late-stage clinical biopharmaceutical company dedicated to forging a new era of psychiatry by applying scientific rigor to psychedelics to develop accessible treatments for mental health disorders.