Note: The job is a remote job and is open to candidates in USA. Faeth Therapeutics is a clinical-stage oncology company focused on advancing innovative therapies. They are seeking an experienced Clinical Data Manager to support clinical data management activities across two active clinical trials, ensuring high-quality, reliable clinical data through effective data management processes.
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
Skills
- 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
- Knowledge of GCP and regulatory requirements
- Strong attention to detail and problem-solving skills
- Excellent communication and cross-functional collaboration skills
- Familiarity with oncology trials is preferred
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
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