Lead Clinical Trial Manager jobs in United States
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Absci · 1 week ago

Lead Clinical Trial Manager

Absci is a clinical-stage biotechnology company advancing novel therapeutics using generative AI. They are seeking a Lead Clinical Trial Manager to oversee clinical research initiatives and manage the operational aspects of clinical trials, ensuring compliance with regulatory standards and company objectives.

Artificial Intelligence (AI)BiopharmaBiotechnologyLife Science
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Develop and maintain effective working relationships with cross-functional teams, external partners (CROs, vendors), and study sites to ensure collaboration and alignment on trial objectives
Manage Contract Research Organizations (CROs) to ensure that all clinical operations are carried out in alignment with the study’s goals, budget, and timelines
Ensure robust patient recruitment and retention strategies are in place and effectively executed
Author, review, and maintain Standard Operating Procedures (SOPs) related to clinical research and operations ensuring high quality, compliance with the study protocol and regulatory requirements across all trials
Support design, implementation, and oversight of clinical trials from concept through completion, ensuring adherence to protocols, regulatory requirements, and ethical standards
Identify potential risks and implement contingency plans
Ensure accurate data collection, documentation, and record-keeping
Support analysis and interpretation of clinical data, prepare reports, and communicate findings to internal stakeholders and regulatory agencies
Stay informed about industry developments, regulatory changes, and advancements in clinical research methodologies to inform trial design and execution strategies
Responsible for the integrity, confidentiality, and security of all research data

Qualification

Clinical trial managementRegulatory affairsClinical Practice (GCP)Life sciences degreeAnalytical skillsLeadership skillsCommunication skillsOrganizational skillsProblem-solving abilities

Required

Bachelors Degree in life sciences, pharmacology or related field a must
Minimum of 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
Exceptional organizational, communication, and leadership skills, with the ability to manage multiple projects and teams in a fast-paced environment
Strong analytical and problem-solving abilities, with a meticulous attention to detail
Demonstrated capability to work collaboratively across various departments and with external partners to achieve objectives
Ability to work in a fast-paced environment and manage multiple projects simultaneously
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 United States is required

Preferred

Advanced degree (MSc., Ph.D., PharmD, MD) in life sciences, pharmacology, or related field

Benefits

Medical, dental, and vision benefits
The ability to participate in our employee stock purchase plan
Unlimited vacation
Parental leave
Breakfast and lunch for onsite employees
Employee assistance program
Voluntary life and disability insurance
Annual bonus potential
401(k) with a generous company match

Company

Absci

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Absci is the drug & target discovery company harnessing deep learning AI & synthetic biology to expand the therapeutic potential of proteins

H1B Sponsorship

Absci has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (3)
2023 (1)
2022 (3)
2021 (2)
2020 (2)

Funding

Current Stage
Public Company
Total Funding
$394.26M
Key Investors
AMDMerck Global Health Innovation FundCasdin Capital
2025-07-24Post Ipo Equity· $50M
2025-01-08Post Ipo Equity· $20M
2024-02-27Post Ipo Equity· $86.4M

Leadership Team

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Sean McClain
Founder & CEO
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Andreas Busch
Chief Innovation Officer
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Company data provided by crunchbase