[Hiring] Clinical Compliance Manager @Parexel

Role Description

We are currently recruiting for an experienced Compliance Manager to join one of our growing sponsors in either Poland or Spain. This position provides GCP compliance support to clinical study teams under the direction of the Sr. Manager or the Associate Director.

• Provide expertise and guidance regarding regulatory requirements, GCP guidelines, and sponsor Standard Operating Procedures (SOPs) for the conduct of clinical studies.
• 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 action plans to address quality and compliance risks.
• Serve as an important conduit to the broader organization to ensure a culture of quality and compliance.
• 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.
• Identify and escalate significant quality and compliance issues to the Head of Clinical Quality & Compliance and relevant leadership.
• 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.

Qualifications

• Minimum 5 years clinical operational experience, e.g. clinical trial manager, clinical compliance manager, clinical project manager, etc.
• Experience 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.
• Working knowledge of CAPA management, risk management, regulatory inspections.

Company Description

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base. We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.