Clinical Data Manager

Responsibilities

• Lead day-to-day data management activities for assigned clinical trials (Phase 2 and Phase 1b)
• Oversee CRO and vendor data management deliverables to ensure timelines, quality, and compliance
• Review and contribute to key study documents, including: Data Management Plans (DMPs), Case Report Forms (CRFs) / eCRFs, Edit check specifications, Data transfer specifications
• Manage database build, UAT, and database lock activities
• Ensure data integrity, consistency, and completeness through ongoing data review and cleaning
• Maintain monitoring query generation and resolution timelines
• Perform data review, listings review, and support medical data review activities
• Collaborate with biostatistics on data standards (e.g., CDISC/SDTM) and analysis datasets
• Ensure compliance with GCP, regulatory requirements, and company SOPs
• Support inspection readiness and participate in audits/inspections as needed
• Contribute to process improvements and best practices in data management

Requirements

• Bachelor’s degree in life sciences, computer science, or related field (advanced degree a plus)
• 5–8 years of clinical data management experience in biotech, pharma, or CRO settings
• Experience supporting early- to mid-phase clinical trials (Phase 1–2 required)
• Hands-on experience with EDC systems (e.g., Medidata Rave, Veeva, Oracle InForm)
• Strong understanding of clinical data standards (CDISC, SDTM)
• Experience managing CROs and external vendors
• Familiarity with oncology trials is preferred
• Knowledge of GCP and regulatory requirements
• Strong attention to detail and problem-solving skills
• Excellent communication and cross-functional collaboration skills

Pay

Compensation Range: $125,000 - $175,000 (actual compensation may vary based on experience, qualifications and location)

Schedule

Remote (U.S.)