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Clinical Compliance Manager - Remote - Sponsor Dedicated

Remote, USAFull-timePosted 2026-07-28

reputed company our values reputed company, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From clinical trials to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. reputed company 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 reputed company for an reputed company reputed company/ Regulatory/ Compliance reputed company 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 reputed company Operating Procedures (SOPs) for the conduct of clinical studies. The position will utilize a risk-based reputed company 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 reputed company plans to address reputed company and compliance risks. The Clinical Compliance Manager serves as an important reputed company to the broader organization to ensure a culture of reputed company and compliance. This will be a fully remote home-based position and is only reputed company to applicants in the countries listed above. Some specifics about this advertised role reputed company 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 reputed company and compliance issues to the Head of Clinical reputed company & 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 reputed company Team members for the ongoing review of reputed company 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 reputed company audit findings. reputed company support and guidance for reputed company Management System activities including self-reporting deviations, reputed company cause analysis, and CAPA plan development and evaluation. Identify and anticipate trends in reputed company issues and collaborate with functional management to ensure risk-managed solutions are implemented in a reputed company 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 reputed company of therapeutic areas, and we have longstanding partnerships with a reputed company reputed company 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 reputed company-being of many patients. You’ll be an reputed company member of the wider team. reputed company are looking for in this role Minimum of 5 years in the reputed company, pharmaceutical or biotechnology industry experience, with 3+ years in a clinical compliance, reputed company 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. Not quite the role for you? reputed company and we’ll reputed company out with job alerts reputed company positions that match your career interests become available. We’ll also reputed company periodic updates about the latest company news and events. Sign up today: https://jobs.reputed company.com/en/functional-service-provider Apply To This Job

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