Senior Clinical Data Manager
RTI International
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $108,000 - $131,000 per year
Job Level
Senior
Tech Stack
Google Cloud PlatformSQL
About the role
- Act as the lead data manager and provide the associated expertise for assigned Phase II/III trials, ensuring timely delivery of high-quality, submission-ready data
- In collaboration with trial statisticians, provide strategic input into study designs, protocol development, and data collection strategies to optimize trial efficiency and data flow
- Oversee and perform work to author, maintain, and implement study-level data management plans (DMPs), CRF/eCRF specifications, edit checks, validation rules, and other key documentation
- Drive continuous alignment of data management strategy with overall program milestones and regulatory objectives
- Ensure accuracy, consistency, and completeness of trial data through ongoing review, cleaning, and reconciliation (SAE, labs, imaging, biomarkers, PK, PRO/ePRO, etc.)
- Lead data review meetings, ensuring timely identification and resolution of discrepancies
- Coordinate interim analyses, database snapshots, and final database lock, ensuring data integrity for regulatory filings and publications
- Champion and help design and implement risk-based monitoring (RBQM), centralized data review, and technology-enabled approaches to enhance efficiency and reliability of data cleaning
- Provide oversight, governance, and quality management of CRO data management deliverables, holding vendors accountable to timelines, budget, and quality
Requirements
- Bachelor's degree in Life Sciences, Computer Science, or a related field and a minimum of 8 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) and other systems for clinical trials implemented in compliance with appropriate regulations (e.g., 21 CFR Part 11 compliance)
- Strong leadership and project management skills, with the ability to manage multiple priorities in fast-paced environments
- Exceptional problem-solving and analytical ability, with a focus on data integrity and risk management
- Skilled communicator, able to influence and collaborate across cross-functional teams and with external partners
- Vendor/CRO oversight experience
- 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
- Competitive base salary
- Generous paid time off policy
- Merit-based annual increases
- Bonus opportunities
- Robust recognition program
- Competitive range of insurance plans (including health, dental, life, and short-term and long-term disability)
- Access to a retirement savings program such as a 401(k) plan
- Paid parental leave for all parents
- Financial assistance with adoption expenses or infertility treatments
- Financial reimbursement for education and developmental opportunities
- Employee assistance program
- Wellness programs
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical data managementdata management plansmedical codingCDISC standardsSASSQLEDC platformsdata cleaningrisk-based monitoringdata integrity
Soft skills
leadershipproject managementproblem-solvinganalytical abilitycommunicationcollaborationinfluencejudgmentindependenceoutcome-driven