Clinical Compliance Manager

🔥 14 hours ago

🌐 Spain, Poland – Remote

🇪🇸 Spain – Remote 🇵🇱 Poland – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Provide GCP compliance support to clinical study teams under the direction of the Sr. Manager or Associate Director • Provide expertise and guidance regarding regulatory requirements, GCP guidelines, and sponsor SOPs for clinical studies • Use a risk-based strategy to prioritize compliance support for clinical activities • Identify and escalate compliance issues and support decision-making • Support development and execution of action plans addressing quality and compliance risks • Act as a Clinical Compliance member of clinical study teams for relevant Therapeutic Areas • Develop relationships with R&D personnel and provide coaching and compliance guidance • Collaborate on ongoing risk assessments of clinical trial activity • Identify priority studies, compliance metrics, high-risk vendors, and key compliance activities • Identify and escalate significant quality and compliance issues, including assessment of serious breaches • Participate in CRO/vendor governance teams and vendor evaluations as a subject matter expert • Support clinical teams in drafting responses and CAPAs to audit findings • Support Quality Management System activities, including deviation self-reporting, root cause analysis, and CAPA plan development and evaluation • Identify trends in quality issues and collaborate on risk-managed solutions • Lead and manage inspection readiness activities and ensure project teams are trained and prepared for regulatory inspections

🎯 Requirements

• 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 • Experience with international regulations, guidelines and standards • Working knowledge of CAPA management, risk management, and regulatory inspections

🏖️ Benefits

• 100% remote home-based position • Sponsor-dedicated role