Clinical Trial Manager

Absci Corp.; Northern (KY); Hybrid; USD 90,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Paid time off

401(k) with match

Job summary

Absci Corp. is seeking an experienced Clinical Trial Manager to independently lead end-to-end operational execution of global Phase II-III trials.

You will manage CROs, vendors, and internal teams to ensure quality, compliance, and efficiency throughout startup to closeout. You will develop study-level operational plans and oversee TMF quality, recruit and retain patients, and coordinate with legal and finance on contracts and budgets.

Qualifications

• 5+ years of direct clinical trial management experience in pharma/biotech/CRO.
• Familiar with GCP, FDA regulations and ICH guidelines.
• Experience configuring and managing electronic patient-reported outcomes (eCOA) systems.
• Knowledge of clinical trial regulatory filing requirements across major regions (US, EU, UK).
• Willingness to travel up to 20% to oversee trials and attend meetings.

Responsibilities

• Independently manage all operational aspects of Phase II-III trials from startup to closeout.
• Oversee CROs and vendors to ensure alignment with timelines and regulatory standards.
• Develop and maintain operational plans, monitoring, communication, and risk management.
• Ensure robust patient recruitment and retention strategies with sites and CROs.
• Collaborate with legal and finance to manage study budgets and contracts.

Skills

Clinical trial management

Regulatory compliance

CRO/vendor management

GCP compliance

Data analysis

Site monitoring

Team collaboration

Education

Bachelor's degree in life sciences or related

Advanced degree welcomed

Job description

About Absci

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. Learn more at www.absci.com or follow us on LinkedIn @absci, X @Abscibio, and YouTube.

We are seeking an experienced 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 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

• 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.

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 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.

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, 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.
• 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.

Absci offers highly competitive salaries and benefits, including medical and dental insurance, paid time off, and 401(k) with a generous company match.

Legal authorization to work in the U.S. is required. We are not able to sponsor individuals for employment visas for this job.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Legal authorization to work in the United States is required. Absci is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, sexual orientation, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, marital status, or any characteristic protected under applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which they have applied should make a request to the recruiter or hiring manager, or contact [e-mail].