Clinical Data Manager / Senior Clinical Data Manager (Contract)

Role overview

Provide contract clinical data management support during time-sensitive milestones for an in-vitro diagnostic clinical validation study. The work centers on maintaining clean, reliable, inspection-ready clinical data, preparing for database lock, and developing documentation that supports derived variables and statistical outputs. The role is suited to an experienced CDM professional who can operate independently with limited ramp-up.

Responsibilities

- Perform ongoing data cleaning, query creation and resolution, discrepancy management, and review across electronic data capture and related collection systems. - Reconcile clinical records with sample information and other study data, while supporting medical coding activities when required. - Analyze data-quality reports, convert findings into actionable queries, and track issues through resolution. - Support CRF freeze and database-lock readiness, including preparation activities and participation in study team meetings. - Produce concise weekly updates summarizing completed work, open risks, and blockers. - Draft and finalize derived-variable specifications and requirements, contribute to table, figure, and listing specifications, and provide limited programming or implementation support where qualified.

Requirements

- At least 3–5 years of hands-on clinical data management experience in a pharmaceutical, medical device, diagnostics, or CRO environment. - Direct experience supporting clinical-trial database lock activities. - Proficiency with Medidata Rave EDC or comparable experience that transfers directly to the role. - Strong organization, written communication, verbal communication, and ability to work independently. - For the senior level: 5 or more years of CDM experience, including authoring derived-variable or TFL specifications. - For the senior level: ability to interpret a Statistical Analysis Plan and translate it into clear specification documents.

Nice to have

Experience in oncology, diagnostics, or regulated IVD/device studies; R programming; familiarity with AI tools for data review or scripting; and exposure to Clario or comparable imaging or adjudication platforms.