Clinical Trial Manager

🔥 14 hours ago

🇺🇸 United States – Remote

💵 $115k - $150k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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Absci

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2011

🧬 Biotechnology

🤖 Artificial Intelligence

💊 Pharmaceuticals

Biotechnology • Artificial Intelligence • Pharmaceuticals

Absci is a biotechnology company that uses generative artificial intelligence together with wet-lab validation to design de novo biologics, primarily antibodies. Its integrated AI Drug Creation Platform performs data generation, model training, de novo design, multi-parametric lead optimization, and AI-enabled target discovery (using reverse immunology) to uncover novel antibody/target pairs and accelerate IND-enabling studies. Absci advances internal and partnered therapeutic programs—such as ABS-201, a designed antibody targeting prolactin receptors for androgenetic alopecia—and emphasizes rapid iterative cycles between AI and lab work to shorten biologics discovery timelines.

📋 Description

• Independently manage all operational aspects of assigned Phase II–III global clinical trials from startup through closeout • Ensure adherence to protocols, regulatory requirements, and ethical standards • Oversee CROs and vendors against study goals, regulatory standards, and timelines • Develop and maintain study-level operational, monitoring, communication, and risk-management plans • Review monitoring visit reports and ensure Trial Master File quality control • Maintain study documentation and operational trackers for Sponsor oversight • Implement patient recruitment and retention strategies with sites and CROs • Partner with legal and finance teams on study budgets, insurance adequacy, privacy and data-protection protocols, and contracts • Identify operational risks and implement mitigation and contingency plans • Support clinical-data analysis, troubleshooting, interpretation, reporting, and stakeholder communication • Monitor industry developments, regulatory changes, and clinical research methodologies • Build relationships with cross-functional teams, CROs, vendors, and investigator sites • Communicate with sites and stakeholders on sensitive health topics while protecting participant safety and dignity

🎯 Requirements

• Bachelor’s Degree in life sciences, pharmacology, or related field • 5 years of direct experience in clinical trial management within the pharmaceutical, biotechnology, or CRO industry • Clinical trial management experience in an industry sponsor setting • 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 • Legal authorization to work in the U.S. required • Must not require employment visa sponsorship • Experience in women’s health, pain, immunology, and/or dermatology studies is a plus • Advanced degree (MSc., Ph.D., PharmD, MD) is welcome but not required

🏖️ Benefits

• Medical insurance • Dental insurance • Vision insurance • Paid time off • Unlimited vacation • Parental leave • Employee assistance program • Voluntary life and disability insurance • Annual bonus potential • 401(k) with a generous company match • Equity • Home-office remote work arrangement