Regional Clinical Compliance Manager

🕒 July 17

🇷🇴 Romania – Remote

💵 RON243.2k - RON304k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

👻 Ghost score 12%

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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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Serve as the primary country-team contact for GCP requirements, company and study-specific procedures, and compliance-related queries • Provide expert guidance and interpretation of regulations and internal standards • Analyze and confirm initial country- and site-specific risks, including critical data and key processes • Communicate country and site trends and lessons learned to Clinical Operations functions • Align with Global Clinical Compliance on executing the Study Health Check Plan at country and site level • Lead and support key process reviews through remote desk checks • Identify high-risk sites using historical performance, inspection outcomes, recruitment volumes, feasibility assessments, site-selection risks, and study-conduct non-compliances • Conduct risk-based Site Compliance Visits at identified high-risk sites • Support country teams in identifying, managing, and resolving compliance issues • Support and manage CAPAs, including risk assessments, root cause analyses, effectiveness measures, and timely action completion • Support the Regional Clinical Compliance Inspection and Audit Support team with site audit and inspection preparation and conduct • Safeguard patient safety, data integrity, and inspection readiness

🎯 Requirements

• Bachelor’s degree (BS/BA or equivalent) or higher in a scientific, medical or healthcare discipline is required, with exceptions potentially made for candidates with equivalent appropriate Clinical Operations experience • Minimum 5 years of progressive experience in clinical operations roles • Minimum 4 years’ experience in a GCP compliance or equivalent quality role • Understanding of clinical trial processes and thorough knowledge of ICH-GCP and associated regulatory guidelines • Analytical and problem-solving skills • High attention to detail and quality orientation • Excellent communication and stakeholder management skills • Excellent English and Romanian written and verbal communication and interpersonal skills • Excellent organizational skills and ability to prioritize and multitask • Ability to work independently in a multicultural setting and handle multiple priorities in a fast-paced environment • PC literacy required • MS Office skills (Outlook, Word, Excel, PowerPoint) • Experience in oncology global trials is preferred

🏖️ Benefits

• Equal opportunity employment • Travel up to 20% or less