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 Manager, Clinical Quality 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 Manager, Clinical Quality and GCP Compliance will serve as an advisor to Clinical Affairs project teams for adherence to quality and compliance standards. The Manager, Clinical Quality 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.
Demonstrates 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 use computers daily in an interactive manner for extended periods of time and up to 8 hours per day.
Ability to sit and/or stand for an extended period of time.
Ability and willingness to travel (by land and air), both domestically and internationally, at least 30% of the time.
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.
Regular and reliable attendance.
Bachelor’s degree in health sciences or a related field preferred.
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.
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.
Internal Number: 3571
About Exact Sciences
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