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Senior Clinical Data Manager

Data ScientistData ScientistFull TimeRemoteTeam 1,001-5,000Since 1958H1B No SponsorCompany Site LinkedIn

Location

United States

Posted

93 days ago

Salary

$108K - $131K / year

Bachelor Degree8 yrs expExperience acceptedEnglishGoogle Cloud PlatformSQL

Job Description

• 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

Job 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