Summary
- Serve as Clinical Data Management program lead for a new product, providing end-to-end data management leadership across clinical studies from start-up through database lock, submission support, and inspection readiness.
Responsibilities
- Lead individual studies and program-level data management strategy and execution.
- Develop/drive data management strategy (start-up planning, database build oversight, data review approach, risk management, database lock, submission readiness).
- Ensure high-quality, timely, decision-ready clinical trial data.
- Oversee CROs and data management vendors (expectations, accountability, quality/compliance, timeline adherence).
- Partner cross-functionally (Biostatistics, Statistical Programming, Clinical Ops, Medical Monitoring, Safety, Regulatory Affairs) on priorities and deliverables.
- Lead cross-functional data review; identify/escalate/resolve data issues, trends, risks, and quality concerns.
- Oversee/contribute to key documents (Data Management Plan, edit checks, validation/reconciliation plans, data transfer agreements, data review plans, database lock documentation).
- Travel ~10%; evening/weekend work may be required.
- Use AI to drive program/portfolio/functional performance.
Required Skills/Knowledge
- EDC systems: Medidata RAVE or Veeva.
- GCP, CDISC/CDASH, ICH guidelines, FDA regulations.
- Excellent communication; strong analytical/problem-solving.
Required Qualifications
- BS/MS in Life Sciences, Computer Science, Mathematics, Health Sciences, or related.
- 10+ years data management experience in pharma/biotech/CRO.
- Experience leading study teams/vendors/people; ability to mentor.
- Oncology therapeutic area experience.
- Proven ability to manage CRO relationships and data management deliverables.
- Experience using AI-enabled tools.
Benefits (as stated)
- Health Coverage (medical, pharmacy, dental, vision).
- Wellbeing programs (incl. EAP).
- Financial wellbeing/protection (401(k), disability, life/accident insurance, and related protections).
- Paid Time Off (flexible time off/paid vacation and paid national holidays as described), plus additional time-off options based on eligibility.
Physical/Work Environment
- Moderate noise; sit/reach/talk-hear; occasionally lift/move up to 20 lbs; close and distance vision required.