Clinical Trial Manager

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At Exact Sciences were helpingchange how the world prevents detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purposedriven career an inclusive culture and robust benefits to support your life while youre working to help others.

Position Overview

The Clinical Trial Manager (CTM) is responsible for supporting or leading the management planning and closure of clinical studies. The CTM works collaboratively and crossfunctionally in an exciting fast paced environment to oversee the daytoday operations of assigned clinical studies and ensure the successful of the companys clinical research plans.

This position may be remote.

Essential Duties

Include but are not limited to the following:

• Coordinate and oversee the operational aspects of a study including planning startup 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 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 startup 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 crossfunctional 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 knowledgesharing 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 companys 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 offsite meetings and conferences as needed.

Minimum Qualifications

• Bachelors 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 startup 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 Qualifications

• 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.

Salary Range:

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation holidays volunteering and personal time) paid leave for parents and caregivers a retirement savings plan wellness support and health benefits including medical prescription drug dental and vision coverage. Learn more about our benefits.

Our success relies on the experiences and perspectives of a diverse team and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation please contact us here.

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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age color creed disability gender identity national origin protected veteran status race religion sex sexual orientation and any other status protected by applicable local state or federal law. Any applicant or employee may request to view applicable portions of the companys affirmative action program.

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