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United States
Remote only
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Clinical Data Manager / Senior Clinical Data Manager based in United States.
This is a remote contract opportunity supporting a critical clinical validation study through a time-sensitive phase of execution.
The role focuses on maintaining high-quality clinical data through ongoing review, cleaning, reconciliation, and query management.
You will contribute directly to database lock readiness and help ensure study data is accurate, complete, and reliable.
The position also includes developing data specifications and supporting tables, figures, and listings documentation.
You’ll work closely with clinical, data, and statistical stakeholders in a collaborative, quality-focused environment.
Senior-level professionals will take on additional responsibility for derived variable and TFL specifications and SAP interpretation.
This is an opportunity to apply hands-on clinical data management expertise to an important diagnostic development program.
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, helping ensure data is complete and prepared for critical study milestones.
Participate in study team meetings and provide concise weekly written updates covering completed work, risks, blockers, and priorities.
Develop and finalize Derived Variable specifications and related requirements documentation using established templates and conventions.
Support Table, Figure, and Listing specifications and review them against the Statistical Analysis Plan.
At the Senior level, interpret the Statistical Analysis Plan and translate its requirements into clear, actionable specification documents.
Provide limited statistical programming or implementation support for derived variables and TFL-related datasets where applicable.
Collaborate effectively with cross-functional stakeholders while working independently and maintaining high standards of data quality and documentation.
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 should be able to read and interpret Statistical Analysis Plans and translate their requirements into specification documentation.
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, data review, or scripting is advantageous.
Familiarity with Clario or comparable imaging and adjudication data platforms is beneficial.
Fully remote contract position.
Hourly compensation of $70–$85 per hour, depending on experience, skills, and education.
Opportunity to support a time-critical clinical validation program within a diagnostics-focused environment.
Hands-on exposure to clinical data management, database lock preparation, data specifications, and clinical study operations.
Opportunity to collaborate with multidisciplinary clinical, data, and statistical teams.
Flexible remote working environment with the opportunity to contribute independently to high-impact study milestones.
