Freenome · 19 hours ago
Senior Clinical Trial Manager
United States
Full-time
Remote
Senior Level
$158K/yr - $222K/yr
6+ years expFreenome is seeking a Senior Clinical Trial Manager to grow their Clinical Development team. The role involves operationalizing and executing clinical validation studies and clinical utility studies to support IVD and LDT products, with a focus on bringing early cancer detection tests to market. The ideal candidate will manage clinical study support staff, oversee study execution, and ensure compliance with regulatory requirements.
BiotechnologyHealth CareHealth DiagnosticsOncologyPersonal Health
Responsibilities
Execute deliverables of all aspects of assigned clinical studies, including, but not limited to, investigator selection, vendor selection, study startup activities and site initiation, preparation of study documentation, including protocols, consent documents, laboratory manuals, biospecimen tracking, clinical data oversight, and closeout activities
Manage, lead and mentor clinical study support staff (CRAs, CTAs) as needed
Participate in soliciting and reviewing vendor/clinical site proposals and budgets, and subsequent selection, contracting, invoicing, and management of study vendors and/or CRO(s) as required
Collaborate with other clinical trial managers on the team to determine lessons learned and implement best practices across all clinical programs
Provide regular updates of study progress to key internal stakeholders
Proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues, as needed
Identify barriers to timely and successful study execution and propose solutions
Provide monitoring oversight by reviewing monitoring schedules, metrics, and reports. May oversee or manage clinical documentation and monitoring reports. May be responsible for conducting on-site initiation visits and interim monitoring visits and creating applicable documentation
Contribute to clinical study feasibility and timeline assessments
Ensure compliance with all applicable regulatory requirements by monitoring compliance with all company standard operating procedures (SOPs), FDA regulations, GCP guidance, and applicable international regulations concerning clinical activities
Establish and maintain effective working relationships with coworkers, managers, and clients/customers
Qualification
Required
BA/BS degree and at least six years' of clinical trial management industry experience (biopharma, medical device, or closely related field)
A strong working knowledge of clinical trial operations, clinical study design, study enrollment planning, strategies and management, and site monitoring
Strong experience in the management of CROs and other vendors/suppliers
Working knowledge of the Medical Device Regulations, CFR Parts 11, 50, 54, 56 and 812 and ICH GCP guidelines
Ability to work independently as well as to inspire and motivate the team
Proven project management skills and study leadership ability
Excellent problem-solving ability, verbal, and written communication skills
Preferred
Advanced degree preferred, additional coursework in clinical trial planning and execution
Industry experience within in vitro diagnostics (IVD) space desired
Clinical experience in oncology, ideally in diagnostics product development
Benefits
Equity
Cash bonuses
Full range of medical, financial, and other benefits
Company
Freenome
Freenome is a biotechnology company developing blood tests for early cancer detection to improve access to routine screening.
201-500 employees
H1B Sponsorship
Freenome 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 (7)
2024 (11)
2023 (15)
2022 (10)
2021 (7)
2020 (7)
Funding
Current Stage
Late StageTotal Funding
$1.53BKey Investors
RocheExact SciencesS32
2025-12-04Acquired
2025-11-17Corporate Round· $75M
2025-08-06Corporate Round· $50M
Leadership Team
Aaron Elliott
Chief Executive Officer
Riley Ennis
Co-Founder
Recent News
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