Oversee end-to-end data management activities across multiple global clinical trials
Ensure the integrity, accuracy, and completeness of clinical trial data in compliance with GCP and regulatory guidelines
Act as the lead data manager for Phase II/III trials, ensuring timely delivery of high-quality data
Collaborate with trial statisticians on study designs and data collection strategies
Lead data review meetings and coordinate interim analyses, database snapshots, and final database lock
Provide oversight and quality management of CRO data management deliverables
Collaborate on regulatory submissions and health authority inspections
Requirements
Bachelor's degree in Life Sciences, Computer Science, or a related field
Minimum 12 years of progressive experience in clinical data management within a biotech, pharmaceutical, or CRO environment for trials conducted under INDs or equivalent experience
Proven track record of leading global Phase II/III clinical trials through development, database lock, and submission
Deep understanding of ICH-GCP, FDA, EMA, and other global regulatory requirements, including expertise in medical coding, CDISC standards (SDTM, ADaM), and associated electronic data submission to regulatory agencies
Proficiency with EDC platforms (e.g., Medidata Rave, DFexplore)
Strong leadership and project management skills
Exceptional problem-solving and analytical ability
Technical proficiency in SAS, SQL, or other data programming languages highly desirable
Demonstrated ability to work independently, exercise judgment, and drive outcomes with minimal supervision
Benefits
Health insurance
401(k) matching
Paid parental leave
Financial assistance with adoption expenses
Financial reimbursement for education and developmental opportunities
Employee assistance program
Paid time off
Merit-based annual increases
Bonus opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical data managementdata programming languagesSASSQLmedical codingCDISC standardsSDTMADaMelectronic data submissiondata integrity