Clinical Data Manager

GQR; United States; On-site; USD 165,000; Full time

Job summary

A precision medicine oncology company is seeking a Clinical Data Manager (Contractor) to support clinical trials, ensuring data accuracy, integrity, and quality. This remote position involves data management for studies including review, reconciliation, and documentation. Candidates should have a BA/BS in a related discipline and 4-6 years of clinical data management experience, preferably in oncology. Strong knowledge of ICH/GCP, FDA regulations, and CDISC standards is essential.

Qualifications

• 4-6 years in clinical data management, preferably oncology.
• Strong knowledge of ICH/GCP, FDA regulations, and CDISC standards.
• Experience with MedDRA and WHO Drug.

Responsibilities

• Own day-to-day data management activities for assigned studies.
• Perform ongoing data review and data cleaning.
• Support eCRF build, testing, and validation.

Skills

Clinical data management

Data review

Query management

EDC experience (Veeva CDMS)

Education

BA/BS in a related discipline

Job description

Clinical Data Manager (Contract - W2) - 18 Months

Location: Remote US Only

Max pay rate: $80/hour (Est 165k on an annualized basis)

Our client, a precision medicine oncology company, is hiring a Clinical Data Manager (Contractor) to support the execution of clinical trials by ensuring clinical trial data accuracy, integrity, and quality. This is a hands-on role focused on clinical data review, SAE and vendor reconciliations, query management, and database lock readiness in a fast-paced study environment.

Responsibilities

• Own day-to-day data management activities for assigned studies to deliver high-quality, complete study data.
• Perform ongoing data review, SAE reconciliation, vendor data reconciliation, and data cleaning to timeline.
• Support eCRF build and testing, edit checks, validation rules, and UAT.
• Build and maintain study documentation (DMP, Data Review Plan, CRF Completion Guidelines, validation specs).
• Drive query generation and resolution in alignment with protocol and standards.
• Support interim analyses, database lock, and final data deliverables with stats and programming.
• Keep documentation inspection-ready and ensure compliance with SOPs and ICH/GCP.

Qualifications

• BA/BS in a related discipline.
• 4-6 years in clinical data management (oncology preferred).
• Strong knowledge of ICH/GCP, FDA regulations, and CDISC standards.
• Hands-on EDC experience (Veeva CDMS strongly preferred).
• Familiarity with MedDRA and WHO Drug.
• Proven ability to manage reconciliations, queries, and database lock activities in a dynamic environment.