Clinical Trial Manager

About the company

Absci is a clinical-stage biotechnology company advancing novel therapeutics using generative AI. Our Integrated Drug Creation™ platform combines cutting-edge AI models with a synthetic biology data engine, enabling the rapid design of innovative therapeutics that address challenging therapeutic targets. Absci is a global company headquartered in Vancouver, WA, and maintains offices in New York City, Switzerland, and Serbia.

Responsibilities

• Independently manage all operational aspects of assigned Phase II-III global 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, regulatory standards, and timelines.
• Develop and maintain study-level operational plans, including monitoring, communication, and risk management plans, and ensure CRO compliance through monitoring visit report reviews, Trial Master File (TMF) quality control, and maintenance of study documentation and operational trackers to support Sponsor oversight.
• Ensure robust patient recruitment and retention strategies are in place and effectively executed in partnership with sites and CROs.
• Partner with legal and finance teams to manage study budgets, verify clinical trial insurance adequacy, privacy and data protection protocols, and oversee the execution of contracts with sites and vendors.
• 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.
• Build and maintain effective working relationships with cross-functional teams, external partners (CROs, vendors), and sites to ensure alignment on trial objectives.
• Communicate effectively with study sites and internal and external stakeholders on sensitive health topics relevant to the trial, including reproductive and mental health, with attention to participant safety and dignity.

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.
• 5 years of direct experience in clinical trial management within the pharmaceutical, biotechnology, or CRO industry. A combination of education and experience will be considered.
• Must have clinical trial management experience in industry sponsor setting.
• 2-3 years of experience in women's health, pain, immunology, and/or dermatology studies being a plus.
• Experience configuring, implementing, and managing electronic patient-reported outcomes (eCOA) systems, including compliance verification and data quality oversight.
• Good working knowledge of Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and other regulatory requirements in clinical research.
• Familiarity with clinical trial regulatory filing requirements across major regions (US, EU, UK, etc.)
• Ability to travel up to 20% per month as needed to oversee clinical trials at investigator sites, onsite meetings with vendors, and conferences.
• Legal authorization to work in the U.S. is required; visa sponsorship is not available for this position.

Skills

• Operate with a high degree of autonomy, confidently managing the full operational lifecycle of complex clinical trials without close oversight.
• 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, sites, and internal stakeholders when presenting trial updates, compliance metrics, and regulatory information.
• 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.

Benefits

• Medical and dental insurance
• Paid time off
• 401(k) with generous company match

Pay

Compensation Range: $115K - $150K

Schedule

Ability to travel up to 20% per month as needed to oversee clinical trials at investigator sites, onsite meetings with vendors, and conferences.