Senior Clinical Trial Manager

Senior Clinical Trial Manager 

Vancouver, WA (Onsite), Remote/Hybrid (US-based)

We are seeking an experienced Senior Clinical Trial Manager to independently lead the end-to-end operational execution of our clinical trials. This pivotal role combines deep expertise in clinical trial operations with strong cross-functional collaboration skills to ensure our trials are delivered with the highest standards of quality, compliance, and efficiency. The Senior Clinical Trial Manager will serve as the operational lead for assigned studies, driving performance across CRO relationships, investigator sites, and internal teams to advance Absci’s clinical programs.

Responsibilities: 

Trial Management & Execution:

• 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 Contract Research Organizations (CROs) and vendors to ensure all clinical operations are carried out in alignment with the study’s goals, budget, and timelines.
• Develop and maintain study-level operational plans, including monitoring plans, communication plans, and risk management plans.
• Ensure robust patient recruitment and retention strategies are in place and effectively executed in partnership with sites and CROs.
• Play a key role in the company-wide rollout of Veeva Vault, serving as a primary operational user and subject matter resource for clinical trial management, eTMF, and CTMS configuration; partner with IT and clinical leadership to drive adoption, define workflows, and train internal and external stakeholders.

Risk Management:

• Proactively identify potential operational risks across assigned trials and develop and implement mitigation and contingency plans.
• Support analysis, troubleshooting, and interpretation of clinical data; prepare reports and communicate findings to internal stakeholders.
• Stay abreast of industry developments, regulatory changes, and advancements in clinical research methodologies to continuously improve trial execution.

Collaboration & Communication:

• Build and maintain effective working relationships with cross-functional teams, external partners (CROs, vendors), and study sites to ensure alignment on trial objectives.
• Serve as a senior operational resource within the clinical team

You Will Be Successful If You:

• Operate with a high degree of autonomy, confidently managing the full operational lifecycle of complex clinical trials without close oversight.
• Bring strong analytical and problem solving skills to proactively resolve operational challenges before they impact timelines or data quality.
• Build rapport and establish credibility with CROs, investigator sites, and internal stakeholders when presenting trial updates, compliance metrics, and regulatory information.
• Demonstrate meticulous attention to detail across all operational and compliance documentation.
• Thrive in a fast-paced, agile environment and manage multiple concurrent priorities effectively.
• Collaborate effectively across departments and with external partners to achieve shared study objectives.

Qualifications:

• Bachelor’s Degree in life sciences, pharmacology, or related field. Advanced degree (MSc., Ph.D., PharmD, MD) in life sciences, pharmacology, or related field is welcome but not required.
• 8 years of direct experience in clinical trial management within the pharmaceutical, biotechnology, or CRO industry. A combination of education and experience will be considered.
• 2-3 years of experience in phase 1 clinical research and operations within the pharmaceutical or biotechnology industry, with experience in immunology and/or dermatology studies being a plus.
• Good working knowledge of Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and other regulatory requirements in clinical research.
• Familiarity with the IND and CTA filing process.
• Ability to travel up to 20% per month as needed to oversee clinical trials at investigator sites,  onsite meetings with vendors and conferences

The salary range for this position is $145,000- $165,000/year. Competitive equity package applies. Pay offered may vary depending on job-related knowledge, skills, and experience. In addition to equity, compensation packages include a wide range of medical, dental, and vision benefits and ability to participate in our employee stock purchase plan.