Clinical Compliance Manager - Remote - Sponsor Dedicated

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel are currently recruiting for an experienced Quality/ Regulatory/ Compliance professional to join one of our growing sponsors in either the UK, Italy or Germany.

This position provides GCP compliance support to clinical study teams under the direction of the Sr. Manager or the Associate Director. 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.

This will be a fully remote home-based position and is only open to applicants in the countries listed above.

Some specifics about this advertised role

• 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

Who are Parexel

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.

You’ll be an influential member of the wider team.

What we are looking for in this role

• 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.

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