Clinical Compliance Manager

Parexel

Clinical Compliance Manager at Parexel providing GCP compliance support to clinical study teams under leadership direction. Focused on regulatory requirements and quality compliance in clinical trials.

Posted 4/15/2026full-timeRemote • 🇬🇧 United KingdomMid-LevelSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provide GCP compliance support to clinical study teams under the direction of the Sr. Manager or the Associate Director
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 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 fashion
Lead/manage inspection readiness activities and ensure project teams are trained and prepared for regulatory inspections.

Requirements

What you’ll need

Minimum of 5 years in the academic, pharmaceutical or biotechnology industry experience, with 3+ years in a clinical compliance, quality assurance, or regulatory compliance role
Thorough knowledge and understanding of drug development and the clinical trial process
In-depth knowledge of current regulatory and ICH GCP requirements and experience with international regulations, guidelines and standards is required
Working knowledge of CAPA management, risk management, regulatory inspections.

Benefits

Comp & perks

Parexel supports clinical studies across the full range of therapeutic areas
We have longstanding partnerships with a vast client base.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

GCP complianceclinical compliancequality assuranceregulatory complianceCAPA managementrisk managementregulatory inspectionsprotocol reviewvendor evaluationsroot cause analysis

Soft Skills

relationship buildingcoachingcollaborationcommunicationproblem-solvingleadershiporganizational skillsanticipation of trendsguidancetraining