Clinical Data Manager / Senior Clinical Data Manager
New
J
JobgetherClinical Data Management
United StatesContractSenior
Salary70 - 85 USD per hour
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Job Details
- Experience
- 3–5+ years for Clinical Data Manager; 5+ years for Senior Clinical Data Manager
Requirements
- 3–5+ years of hands-on clinical data management experience within a pharmaceutical, medical device, diagnostics, or CRO environment.
- Direct experience supporting clinical trial database lock activities.
- Proficiency with Medidata Rave EDC.
- Ability to work independently with minimal ramp-up and manage priorities effectively in a time-sensitive environment.
- Strong organizational, written, verbal, analytical, and problem-solving skills.
- For Senior-level consideration: 5+ years of clinical data management experience, including experience authoring Derived Variable and/or TFL specifications.
- Senior candidates must be able to read and interpret Statistical Analysis Plans.
- Experience in oncology, diagnostics, IVD, or regulated medical device studies is preferred.
- R programming experience is a plus.
- Familiarity with AI tools such as Claude Code or Gemini for clinical data management workflows is advantageous.
- Familiarity with Clario or comparable imaging and adjudication data platforms is beneficial.
Responsibilities
- Perform ongoing clinical data cleaning, query management, discrepancy resolution, and data review within EDC and other study data collection systems.
- Conduct reconciliation activities, including sample-to-clinical data reconciliation, and provide medical coding support when needed.
- Review data-quality reports and translate identified findings into appropriate queries, resolutions, and follow-up actions.
- Support CRF freeze and database lock readiness activities.
- Participate in study team meetings and provide concise weekly written updates.
- Develop and finalize Derived Variable specifications and related requirements documentation.
- Support Table, Figure, and Listing specifications and review them against the Statistical Analysis Plan.
- Interpret the Statistical Analysis Plan and translate its requirements into clear, actionable specification documents (Senior level).
- Provide limited statistical programming or implementation support for derived variables and TFL-related datasets.
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