Exact Sciences · 11 hours ago
Sr. Clinical Trial Manager
United States
Full-time
Remote
Mid, Senior Level
$110K/yr - $166K/yr
5+ years expExact Sciences is dedicated to changing how the world prevents, detects, and guides treatment for cancer. The Sr. Clinical Trial Manager is responsible for supporting or leading the management, planning, execution, and closure of clinical studies, ensuring successful execution of the company's clinical research plans in a collaborative environment.
BiotechnologyHealth DiagnosticsManufacturingMedical
No H1B
Responsibilities
Coordinate and oversee the operational aspects of a study including planning, start-up, enrollment and close out activities ensuring that deliverables are completed on time, within budget, and in compliance with department procedures, applicable regulations and quality standards
Prepare, review and implement study related plans and documents including project timelines, study protocols, informed consent forms (ICFs), recruitment plans, monitoring plans, study budgets, site contracts & budgets, vendor management plans and other essential clinical study documents
Develop plans for systems and materials required to support the efficient execution of clinical studies and is responsible for effective management during the conduct of the study
Develop, implement and maintain tools to manage, monitor and report on study health & operations, project timelines, and study finances to department management and other stakeholders
Participate in study database development by reviewing and contributing to case report form (CRF) design, CRF completion guideline development, edit check & manual data review requirements, and participation in user acceptance testing (UAT)
Oversee sample management activities including planning, sample handling, kit supply management, sample shipping, processing, and resulting
Develop site recruitment plans and is responsible for the identification, selection, start-up and performance monitoring of clinical research sites
Develop study budgets and is responsible for accurately forecasting and managing study expenses. Oversee site contracting and study budget management including facilitation of site contract and budget negotiations, invoice review and approval, accrual management and maintenance of budget tracking tools
Oversee study and site management activities such as, training, data entry & query resolution, TMF maintenance, and ensure compliance with study plans such as the study protocol, monitoring plans, and recruitment plans
Conduct monitoring activities as needed
Ensure the smooth and efficient closure of studies through development of plans for completion of data verification & review, planning & facilitation of database lock activities, determination of site & IRB/EC readiness for closure, statistical analysis and clinical study report development
Participate in the identification, qualification, selection and management of vendors providing support to clinical studies
Provide oversight and support for assigned clinical operations study team members. Leads cross-functional team meetings, ensuring study goals and priorities are clear. Professionally interacts with investigators and site staff, vendors, key opinion leaders and consultants
Ability to identify, mitigate and manage study risks. Responsible for maintaining ongoing study audit readiness and participates in internal or regulatory authority audits
Provide guidance and support to less experienced team members. Fosters a collaborative and knowledge-sharing environment, promoting continuous learning within the team
Ability to provide oversight to multiple studies
Participate or may facilitate department or project initiatives under the direction of department management or lead clinical trial manager
Uphold company mission and values through accountability, innovation, integrity, quality and teamwork
Support and comply with the company’s Quality Management System policies and procedures
Maintain regular and reliable attendance
Ability to act with an inclusion mindset and model these behaviors for the organization
Ability to work a designated schedule
Ability to work on a mobile device, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day
Ability to work on a computer and phone simultaneously
Ability to travel 20% of working time away from work location, may include overnight/weekend travel
Ability to attend off-site meetings and conferences as needed
Qualification
Required
Bachelor's degree in the life sciences or field as outlined in the essential duties
5+ years of experience in clinical research
1+ year of experience of experience leading project teams through the start-up, study conduct, data management, analysis, close out and report writing of clinical studies
Clinical monitoring experience including data review, query resolution, protocol deviation identification/tracking/trending, site initiation, site maintenance, and site closeout visits
Experience writing, reviewing and editing protocols
Knowledge of applicable quality standards (e.g. Good Clinical Practices (ICH/GCP), ISO 20916) and applicable local and national regulations governing clinical research
Authorization to work in the US without sponsorship
Demonstrated ability to perform the Essential Duties of the position with or without accommodation
Experience providing oversight to external vendors (e.g. CRO, central labs, call centers, DCT providers)
Preferred
1+ year of clinical research experience with a sponsor company or CRO
International study experience, IVDR, and GDPR implementation
Working knowledge of the FDA submission process including, IDE, PMA and 510(k)
Experience as a study coordinator or clinical research associate
Sample management system experience
Benefits
Paid time off (including days for vacation, holidays, volunteering, and personal time)
Paid leave for parents and caregivers
A retirement savings plan
Wellness support
Health benefits including medical, prescription drug, dental, and vision coverage
Company
Exact Sciences
Exact Sciences offers a portfolio of cancer screening and diagnostic tests that span from early detection to treatment monitoring.
5001-10000 employees
Funding
Current Stage
Public CompanyTotal Funding
$2.75B2025-06-20Acquired
2024-04-11Post Ipo Debt· $620.7M
2023-02-23Post Ipo Debt· $500M
Leadership Team
Kevin Conroy
Chairman & CEO
Aaron Bloomer
Executive Vice President, CFO
Recent News
2026-01-23
legacy.thefly.com
2026-01-23
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