Senior Clinical Trial Manager
Absci
June 24, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Responsibilities:
- Independently manage all operational aspects of assigned Phase I clinical trials from startup through closeout, ensuring adherence to protocols, regulatory requirements, and ethical standards.
- Oversee CROs and vendors to align clinical operations with goals, budget, and timelines.
- Develop and maintain study-level operational plans (monitoring, communication, and risk management).
- Ensure effective patient recruitment and retention strategies with sites and CROs.
- Support company rollout of Veeva Vault as a primary operational user/subject matter resource for clinical trial management, eTMF, and CTMS configuration (drive adoption, define workflows, train stakeholders).
Risk management:
- Identify operational risks and implement mitigation/contingency plans.
- Support analysis, troubleshooting, and interpretation of clinical data; prepare reports and communicate findings.
- Stay current on regulatory/industry developments to improve execution.
Collaboration & communication:
- Build relationships with cross-functional teams, CROs/vendors, and study sites to ensure alignment on objectives.
- Serve as a senior operational resource within the clinical team.
Qualifications:
- Bachelor’s degree in life sciences/pharmacology (advanced degree welcome but not required).
- 8+ years clinical trial management experience (pharma/biotech/CRO).
- 2–3 years phase 1 research/operations; immunology and/or dermatology experience a plus.
- Working knowledge of GCP, FDA regulations, and ICH guidelines.
- Familiarity with IND and CTA filing process.
- Travel up to 20%/month.
Compensation/benefits (as stated): $145,000–$165,000/year; competitive equity; medical, dental, vision; employee stock purchase plan.
- Independently manage all operational aspects of assigned Phase I clinical trials from startup through closeout, ensuring adherence to protocols, regulatory requirements, and ethical standards.
- Oversee CROs and vendors to align clinical operations with goals, budget, and timelines.
- Develop and maintain study-level operational plans (monitoring, communication, and risk management).
- Ensure effective patient recruitment and retention strategies with sites and CROs.
- Support company rollout of Veeva Vault as a primary operational user/subject matter resource for clinical trial management, eTMF, and CTMS configuration (drive adoption, define workflows, train stakeholders).
Risk management:
- Identify operational risks and implement mitigation/contingency plans.
- Support analysis, troubleshooting, and interpretation of clinical data; prepare reports and communicate findings.
- Stay current on regulatory/industry developments to improve execution.
Collaboration & communication:
- Build relationships with cross-functional teams, CROs/vendors, and study sites to ensure alignment on objectives.
- Serve as a senior operational resource within the clinical team.
Qualifications:
- Bachelor’s degree in life sciences/pharmacology (advanced degree welcome but not required).
- 8+ years clinical trial management experience (pharma/biotech/CRO).
- 2–3 years phase 1 research/operations; immunology and/or dermatology experience a plus.
- Working knowledge of GCP, FDA regulations, and ICH guidelines.
- Familiarity with IND and CTA filing process.
- Travel up to 20%/month.
Compensation/benefits (as stated): $145,000–$165,000/year; competitive equity; medical, dental, vision; employee stock purchase plan.