Senior Clinical Quality Specialist

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At Exact Sciences, we're 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 purpose-driven career, an inclusive culture, and robust benefits to support your life while you're working to help others.

Position Overview

The Senior Clinical Quality Specialist is part of the clinical affairs team, which is responsible for planning, executing, managing, and closing projects associated with the company clinical study plans. The Senior Clinical Quality Specialist will partner with the clinical affairs team to drive clinical quality assurance (CQA) activities to include internal, vendor, and site audits, standard operating procedure (SOP) development and review, and process improvement. The Senior Clinical Quality Specialist will serve as a quality subject matter expert (SME) to clinical affairs project teams for adherence to quality and compliance standards, and will provide support to members of multidisciplinary project teams, both internally and externally. The Senior Clinical Quality Specialist will also support other key projects and initiatives for the department, as needed.

Essential Duties:

Include, but are not limited to, the following:

• Provide guidance to clinical affairs to ensure adherence to all regulations, guidelines, SOPs, and local, regional, and national requirements, as needed.
• Draft, review, and revise clinical SOPs and assess consistency across internal processes, Good Clinical Practice (GCP), and regulations.
• Perform quality control (QC) review of study documents prior to finalization; including, but not limited to, protocols, informed consent forms, protocol amendments, and project plans.
• Partner with contract research organizations (CROs), vendors, and external collaborators to assess and maintain GCP compliance.
• Participate in quality investigations; including, but not limited to, corrective action and preventative action (CAPA) plans.
• Lead clinical audits of CROs, sites, vendors, system validation, and internal processes.
• Collaborate with clinical study managers to develop study-specific site audit plans.
• Contribute to study risk assessment plans and mitigation.
• Perform inspection readiness activities and support regulatory inspections, as needed.
• Participate in cross-functional project or program level meetings to provide clinical quality recommendations.
• Act as a customer advocate throughout the project lifecycle.
• Apply a 'can-do' attitude and apply a strong desire to take ownership of many different projects.
• Apply excellent organization and communication skills.
• Apply excellent interpersonal skills.
• Apply effective project management, decision making, and problem-solving skills.
• Ability to lead and plan.
• Ability to work independently and manage multiple timelines while maintaining the team focus.
• Ability to exercise judgment and determine appropriate action for a variety of problems of varying complexity.
• Ability to manage multiple deadlines.
• 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.
• Regular and reliable attendance.
• Ability to work designated schedule.
• Ability to lift up to 10 pounds for approximately 5% of a typical working day.
• 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 frequently and accurately communicate with colleagues, customers, and vendors in person, via telephone, or by email.
• Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
• Ability to comply with any applicable personal protective equipment requirements.
• Ability and means to travel between Madison locations.
• Ability to travel 30% of working time away from work location, may include overnight/weekend travel.

Minimum Qualifications:

• Bachelor's degree in the Life Sciences or other field related to the essential duties of the position.
• 6+ years of experience in clinical and/or quality.
• 5+ years of experience implementing ICH GCP E6 R(2).
• 3+ years of experience in clinical operations or in a clinical quality assurance role.
• 3+ years of experience with CTMS, EDC, eTMF, and sample management systems.
• 4+ years of experience in end-to-end trial activities to include feasibility, start-up, study conduct, close-out, data management, and report writing of clinical studies.
• 4+ years of experience writing, reviewing, and editing protocols, and clinical study reports.
• Authorization to work in the United States without sponsorship.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Preferred Qualifications

• Experience with global studies and regulations.
• Experience with GCP auditing.
• Experience with In Vitro Diagnostic (IVD) studies and lab site management.
• Understanding of In Vitro Diagnostic Regulations (IVDR).
• Experience with clinical quality audits to include site, vendor, and CRO audits.
• Working knowledge of the Food and Drug Administration (FDA) submission process to include IDE, PMA, and 510(k).
• Awareness of ICH GCP E6 (R3).

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 disability, protected veteran status, and any other status protected by applicable local, state, or federal law.

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