Lead Clinical Trial Manager

Exact Sciences • Madison, WI

1d • Remote

About The Position

At Exact Sciences, we’re helping change 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 purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Lead Clinical Trial Manager (Lead CTM) is highly experienced in clinical study management and is responsible for the effective and efficient planning, execution, and closure of clinical studies. The Lead CTM works collaboratively and cross-functionally in an exciting, fast paced environment to lead the day-to-day operations of assigned clinical studies and ensure the successful execution of the company's clinical research plans. This position may be remote.

Requirements

• 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.

Nice To Haves

• 2+ years of device or IVD experience.
• International study experience, IVDR and GDPR implementation.
• Sample management system and/or Laboratory Information Management System experience.

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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees