AbSci

Clinical Trial Manager

AbSci$110K — $130K *
US-AnywhereRemote in United States
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in life sciences, pharmacology, or related field; advanced degree is a plus.
  • 5 years of direct experience in clinical trial management within pharmaceutical, biotechnology, or CRO settings.
  • Clinical trial management experience in an industry sponsor setting required.
  • 2-3 years of experience in women's health, pain, immunology, and/or dermatology studies preferred.
  • Experience with electronic patient-reported outcomes (eCOA) systems, including compliance verification and data quality oversight.
  • Good knowledge of GCP, FDA regulations, ICH guidelines, and clinical research requirements.
  • Familiarity with regulatory filing requirements across major regions.

Responsibilities

  • Independently manage operational aspects of assigned Phase II-III global clinical trials.
  • Oversee CROs and vendors to ensure alignment with study goals and timelines.
  • Develop and maintain study-level operational plans for monitoring and risk management.
  • Implement patient recruitment and retention strategies with sites and CROs.
  • Partner with legal and finance teams to manage study budgets and contracts.
  • Identify operational risks and develop mitigation plans proactively.
  • Communicate findings and updates effectively to stakeholders.

Benefits

  • Medical and dental insurance.
  • Paid time off.
  • 401(k) with a generous company match.
Full Job Description
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 Trial Management & Execution: • 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.

About AbSci

AbSci is a biotechnology company that specializes in protein production and optimization. The company was founded in 2011 by Sean McClain and is based in Eugene, Oregon. AbSci's proprietary platform, SoluPro, enables the production of complex proteins at a lower cost and in a shorter time frame than traditional methods. The platform has applications in drug discovery, biomanufacturing, and industrial enzymes. AbSci has partnerships with companies such as Astellas Pharma and Alpha Cancer Technologies.
Learn more about AbSci
Size
50 employees
Market Cap
$188.6 million
Industry
NASDAQ

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