RTI International

Senior Clinical Data Manager

RTI International

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇺🇸 United States

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Salary

💰 $108,000 - $131,000 per year

Job Level

Senior

Tech Stack

Google Cloud PlatformSQL

About the role

  • 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
Soft skills
leadershipproject managementproblem-solvinganalytical abilitycollaborationindependent workjudgmentdriving outcomes
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