Exact Sciences Corporation

Director, Clinical Quality and GCP Compliance

Job Locations US-Remote
Req No.
2021-9061
Category
Clinical Operations
Type
Regular Full-Time

Summary of Major Responsibilities

The Director, Clinical Quality and GCP Compliance is part of the clinical affairs team, which is responsible for planning, executing, managing, and closing projects associated with the company clinical study plans. This role will partner with the clinical affairs leadership team to drive clinical quality assurance (CQA) activities to include internal, vendor, and site audits, SOP development and review, process improvement, and training assessment. This position will also oversee the training team within clinical affairs. The Director, Clinical Quality Assurance and GCP Compliance will serve as an advisor to clinical affairs project teams, cross-functional leadership, and stakeholders for adherence to quality and compliance standards. This role will also provide leadership and support to members of multidisciplinary project teams, both internally and externally, and will provide professional development and guidance to assigned clinical affairs team members.

Essential Duties and Responsibilities

  • Provide guidance to clinical affairs to ensure adherence to Good Clinical Practices (GCP), regulations, standard operating procedures (SOPs), and business processes.
  • Maintain accountability for clinical SOP development, harmonization, applicable revisions, implementation, and rollout; support cross-functional SOP initiatives, as needed; assess consistency across internal processes, GCP, and regulations.
  • Perform quality control (QC) review of study documents (e.g., protocols, informed consent forms, protocol amendments, and project plans) prior to finalization.
  • Partner with contract research organizations (CROs), vendors, and external collaborators to assess and maintain GCP compliance.
  • Oversee and lead quality investigations; including, but not limited to, corrective action and preventative action (CAPA) plans.
  • Oversee and lead root cause analysis of site, study, or program level compliance issues; track developed CAPAs or process improvement recommendations to completion.
  • Conduct suspected research misconduct investigations.
  • Advise the clinical operations team on CRO and vendor selection activities; lead clinical audits of CROs, vendors, system validation, and processes.
  • Collaborate with clinical study managers to develop study specific site audit plans.
  • Develop the CQA strategy and supports clinical study project goals; including, but not limited to, study risk assessment plans and mitigation.
  • Identify quality indicators proactively using data analyses across product development programs; address deficiencies noted through analyses and recommend appropriate mitigation plans and process improvement.
  • Maintain accountability for assuring completeness of clinical training plans at department and study level.
  • Develop and implement the training program for the department.
  • Perform inspection readiness activities and support regulatory inspections, as needed.
  • Implement and manage a clinical quality management system (QMS).
  • Participate in cross-functional project or program level meetings to provide clinical quality perspective.
  • Act as a customer advocate throughout the project lifecycle.
  • Develop personnel through open communication of job expectations, planning, monitoring, and providing feedback on assigned responsibilities.
  • Provide performance feedback and initiate career development discussions and planning for all direct reports.
  • Provide coaching, counseling, and disciplining of employees, when required, consistent with the core values of Exact Sciences.
  • Supervise staff; including, but not limited to, organize and prioritize work, write/conduct performance reviews, train/develop, and manage work performance.
  • Communicate goals clearly to employees to ensure understanding and success in achieving them.
  • Motivate and inspire employees to do their best work through coaching.
  • Maintain morale and support employee engagement initiatives.
  • Apply problem-solving and interpersonal skills; apply a ‘can-do’ attitude and a strong desire to take ownership of many different projects.
  • Apply excellent organization and communication skills; ability to deal with decision makers; including, but not limited to, physicians, internal review board (IRB) members, and Food and Drug Administration (FDA) staff.
  • Apply excellent leadership, planning, and project management skills; apply effective decision making and problem-solving skills.
  • Ability to work independently and manage multiple timelines while maintaining the team focus.
  • Ability to frequently and accurately communicate with employees, customers, and vendors in person, via the telephone, or by email.
  • Ability to exercise judgment and determine appropriate action to 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.
  • 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 nights and/or weekends, as needed.
  • 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 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 50% of working time away from work location, may include overnight/weekend travel.

 

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Qualifications

Minimum Qualifications

  • Bachelor’s Degree in the Life Sciences or related field as outlined in the essential duties.
  • 8+ years of experience in clinical research.
  • 5+ years in clinical QA, and/or GCP auditing.
  • 5+ years of experience managing direct reports or project team members in a clinical research environment.
  • Demonstrated ability to plan, conduct, and report clinical quality audits to include site, vendor, and CRO audits.
  • Demonstrated ability to perform end-to-end trial activities to include feasibility, start-up, study conduct, close-out, data management, and report writing of clinical studies.
  • Demonstrated ability to write, review, and edit protocols and clinical study reports.
  • Strong understanding of CTMS, EDC, eTMF, and sample management systems.
  • Strong understanding of a global, multicultural, matrixed environment; demonstrated ability to facilitate, negotiate, problem-solve, and perform conflict resolution.
  • Strong understanding of the FDA submission process, agency sponsor, and site audits.
  • Strong understanding and implementation of ICH GCP E6 R(2).
  • 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 in IVD studies and lab site management.
  • Experience with IVDR, ISO 20916, ISO 13485.
  • Working knowledge of the in-vitro diagnostic (IVD) submission process to include IDE, PMA, and 510(k).

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. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.

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