Exact Sciences · 12 hours ago
Lead Clinical Trial Manager
Madison, WI
Full-time
Hybrid
Senior Level, Lead/Staff
$112K/yr - $190K/yr
7+ years expExact Sciences is dedicated to changing how the world prevents, detects, and guides treatment for cancer. The Lead Clinical Trial Manager is responsible for the effective planning, execution, and closure of clinical studies, leading day-to-day operations and ensuring compliance with regulations and quality standards.
BiotechnologyHealth DiagnosticsManufacturingMedical
No H1B
Responsibilities
Coordinate and lead 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 (when applicable), monitoring plans, study budgets, site contracts & budgets, vendor management plans and other essential clinical study documents
Lead development of strategy and 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
Identify, assimilate and analyze key data to assess study health, proactively identify issues, prioritize tasks & responsibilities, and guide study operations
Ensure effective operationalization of data collection and review through identification of critical data, risk assessment and monitoring strategies, 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, when applicable
Develop the resource requirements, study team structure and detailed study budgets. Accurately forecast, track and manage resources & expenses. Oversee vendor contracting, site contracting and study budget management including facilitation of 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 ensures 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
Lead the identification, qualification, selection and management of vendors providing support to clinical studies, when applicable
Provide leadership and support for assigned clinical operations study team members. Lead cross-functional team meetings, ensuring study goals and priorities are clear. Responsible for relationship management with key opinion leaders & site partners, cooperative groups, pharmaceutical partners (when applicable), and advocacy organizations
Proactively identify, anticipate, mitigate and manage study risks. Responsible for maintaining ongoing study audit readiness and participates in internal or regulatory authority audits
Provide guidance and shares best practices with team members. Foster a collaborative and knowledge-sharing environment, promoting continuous learning within the team and serves as a mentor to new and experienced clinical operations staff
Ability to provide oversight to multiple studies or a program of studies
Lead department or project initiatives under the direction of department management
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 designated schedule
Ability to work on a mobile device, tablet, 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
Attend off site-meetings and conferences, as needed
Qualification
Required
Bachelor's degree in life sciences or field as outlined in the essential duties
7+ years of experience in clinical research
3+ years of clinical research experience with a sponsor company, CRO, or central laboratory
3+ years 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 providing oversight to external vendors (e.g. CRO, central labs, call centers, DCT providers)
Working knowledge of the FDA submission process including IDE, PMA, and 510(k)
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
Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis. We are unable to sponsor or take over sponsorship of employment visas at this time
Demonstrated ability to perform the Essential Duties of the position with or without accommodation
Preferred
2+ years of device or IVD experience
International study experience, IVDR and GDPR implementation
Sample management system and/or Laboratory Information 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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