Clinical Compliance Manager - Poland/Spain - FSP

reputed company our values align, there's no limit to reputed company can reputed company.   At reputed company, we reputed company 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 reputed company do.

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

reputed company are currently recruiting for an reputed company Quality/ Regulatory/ Compliance professional 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. 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, reputed company 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.
• reputed company 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 reputed company 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.
• reputed company / manage inspection readiness activities and ensure project teams are trained and reputed company for regulatory inspections

Who are reputed company

reputed company supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client reputed company.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we reputed company more reputed company drug developments that are critical to the well-being of many patients.

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

reputed company 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 reputed company regulatory and ICH GCP requirements and experience with international regulations, guidelines and standards is required. 
• Working knowledge of CAPA management, risk management, regulatory inspections.

If you are interested, please apply or send your CV to reputed company.kuniewicz@reputed company.com