Clinical Data Manager
New
F
Faeth TherapeuticsBiotech Oncology
Remote (U.S.)Full-TimeMiddle
Salary125,000 - 175,000 USD per year
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Job Details
- Experience
- 5–8 years
- Required Skills
- GCP
Requirements
- Bachelor’s degree in life sciences, computer science, or related field
- 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
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, and 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
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