Clinical Data Manager to support clinical data management activities across two active clinical trials. This individual will play a critical role in ensuring high-quality, reliable clinical data through the design, implementation, and oversight of data management processes. The role requires close collaboration with clinical operations, biostatistics, medical, and external vendors.
Reports to: Chief Medical Officer
Location: Remote (U.S.)
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
* Monitor 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
Compensation Range: $125,000 - $175,000 (actual compensation may vary based on experience, qualifications and location)
Benefits:
* Competitive salary and equity in a well-funded, clinical-stage biotech
* 100% remote work and flexible schedule
* Health, dental, and vision for you and your dependents
* Flexible time off
* Generous parental leave
* Traditional and Roth 401k
* Mission oriented, remote first culture
