• Senior Manager, Clinical Quality Assurance

    Job Locations US-WI-Madison
    Req No.
    2019-4518
    Category
    Clinical Operations
    Type
    Regular Full-Time
  • Summary of Major Responsibilities

    This position 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 Manager, Clinical Quality Assurance and GCP Compliance will partner with the Clinical Affairs Leadership Team to drive Clinical Quality Assurance (CQA) activities including internal, vendor, and site audits, SOP development and review, process improvement, and training assessment. The Senior Manager, Clinical Quality Assurance and GCP Compliance will serve as an advisor to Clinical Affairs project teams for adherence to quality and compliance standards. The Senior Manager, Clinical Quality Assurance and GCP Compliance provides leadership and support to members of multidisciplinary project teams, internally and externally, and provides professional development and guidance to assigned Clinical Affairs personnel.

    Essential Duties and Responsibilities

    • Provide guidance to Clinical Affairs to ensure adherence to GCP, regulations, SOPs, and business processes.
    • Draft, review, and revise Clinical SOPs and assess consistency across internal processes, GCP, and regulations.
    • Perform Quality Control (QC) review of study documents (e.g., protocols, informed consent forms, protocol amendments, project plans) prior to finalization.
    • Partner with CROs, vendors, and external collaborators to assess and maintain GCP compliance.
    • Participate in quality investigations including corrective action and preventative action (CAPA) plans.
    • Perform 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.
    • Participate in 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.
    • Contribute to study risk assessment plans and mitigation.
    • Assess clinical training plans at department and study level for completeness.
    • Support and provide input into the training program for the department.
    • Perform inspection readiness activities and support regulatory inspections as needed.
    • 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.
    • Demonstrated problem-solving and interpersonal skills. Must have a ‘can-do’ attitude and a strong desire to take ownership of many different projects.
    • Excellent organization and communication skills, including experience dealing with decision makers, such as physicians, IRB members, and FDA staff.
    • Excellent leadership, planning, and project management ability; exhibiting 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.
    • 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 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.

    Qualifications

    Minimum Qualifications

    • Bachelor’s degree in the life sciences or a related field.
    • 8+ years of experience in clinical research.
    • 5+ years in Clinical Operations, Clinical QA, and/or GCP auditing.
    • 2+ years of experience managing direct reports or project team members in a clinical research environment.
    • Strong understanding and implementation of ICH GCP E6 R(2).
    • Experience planning, conducting and reporting clinical quality audits, including site, vendor, and CRO audits.
    • Experience with CTMS, EDC, eTMF, and sample management systems.
    • Experience in end-to-end trial activities including feasibility, start-up, study conduct, close-out, data management, and report writing of clinical studies.
    • 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.
    • Working knowledge of the FDA submission process including IDE, PMA, and 510(k).
    • Experience in IVD studies and lab site management.

    #LI-AS2

    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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