Clinical Compliance Manager - US - FSP

Clinical Compliance Manager - US - FSP at Parexel in Boise, Idaho, United States Job Description

Job Summary:

The Clinical Compliance Manager will provide GCP compliance support to therapeutic area and clinical study teams under the direction of the Sr. Manager or the Associate Director, Clinical Compliance. The key activity of the role is providing expertise and guidance regarding regulatory requirements, GCP guidelines, and sponsor Standard Operating Procedures (SOPs) for the conduct of clinical studies. The position will utilize a risk-based strategy to prioritize compliance support for clinical activities, identify and escalate compliance issues, enable decision-making, and support the development and execution of effective and comprehensive action plans to address quality and compliance risks. The Clinical Compliance Manager serves as an important conduit to the broader organization to ensure a culture of quality and compliance. Responsibilities + Provide quality leadership and direction to sponsor R D stakeholders on GCP-related activities/issues and act as GCP expert/consultant for R D colleagues. + Act as a Clinical Compliance member of clinical study teams for relevant Therapeutic Areas. + Develop strong relationships with R D personnel across functions and teams providing coaching and compliance guidance as needed. + Collaborate with stakeholders in conducting ongoing risk assessment of clinical trial activity to identify priority studies, compliance metrics for tracking, high-risk vendors, and key compliance activities (i.e., protocol review, vendor evaluations, inspection readiness). + Identify and escalate significant quality and compliance issues to the Head of Clinical Quality & Compliance and relevant leadership, including the assessment of serious breaches. + Participate as a member of Contract Research Organization (CRO)/Vendor governance teams for assigned Therapeutic Areas/Studies. + Establish a relationship with CRO Quality Team members for the ongoing review of quality and compliance issues. + Participate in vendor evaluations as a Subject Matter Expert (SME) as needed. + Support clinical teams/functions in drafting responses and CAPAs to internal and external audit findings. + Provide support and guidance for sponsor Quality Management System activities including self-reporting deviations, root cause analysis, and CAPA plan development and evaluation. + Identify and anticipate trends in quality issues and collaborate with functional management to ensure risk-managed solutions are implemented in a timely fas

Job Posting:

JC291611750

Posted On:

May 09, 2026

Updated On:

May 09, 2026