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Senior Clinical Trial Manager

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Exact Sciences

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Location:
United States , Madison

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

91000.00 - 155000.00 USD / Year
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Job Description:

The Sr. Clinical Trial Manager (CTM) is responsible for supporting or leading the management, planning, execution, and closure of clinical studies. The Sr. CTM works collaboratively and cross-functionally in an exciting, fast paced environment to oversee the day-to-day operations of assigned clinical studies and ensure the successful execution of the company's clinical research plans.

Job Responsibility:

  • Coordinate and oversee the operational aspects of a study including planning, start-up, enrollment and close out activities
  • 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
  • Develop, implement and maintain tools to manage, monitor and report on study health & operations, project timelines, and study finances
  • 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
  • Oversee study and site management activities such as, training, data entry & query resolution, TMF maintenance
  • Conduct monitoring activities as needed
  • Ensure the smooth and efficient closure of studies
  • Participate in the identification, qualification, selection and management of vendors
  • Provide oversight and support for assigned clinical operations study team members
  • Ability to identify, mitigate and manage study risks
  • Provide guidance and support to less experienced team members
  • Ability to provide oversight to multiple studies
  • Participate or may facilitate department or project initiatives
  • 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

Requirements:

  • 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
  • Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis
  • 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)

Nice to have:

  • 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
What we offer:
  • 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
  • Bonus eligibility

Additional Information:

Job Posted:
February 18, 2026

Employment Type:
Fulltime
Work Type:
Remote work
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