Regional Clinical Compliance Manager

🔥 0 minutes ago

🇧🇷 Brazil – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 11%

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

• Implement Global Clinical Compliance and Inspection Management strategy across BeOne Clinical activities at regional, country, study, and site levels • Provide independent compliance oversight and quality support to BeOne GCO study teams • Maintain study conduct, inspection readiness, and compliance with applicable regulatory requirements • Identify, escalate, track, and trend non-compliance issues, quality events, potential misconduct, and potential Serious Breach • Support development of GCP readiness activities and programs • Provide GCP compliance guidance to Clinical Study Teams and GCO stakeholders • Conduct remote compliance reviews and periodic risk evaluations for assigned studies • Plan and conduct Site Compliance Visits at investigator sites • Evaluate site practices, monitoring quality, study conduct, and GCP compliance • Assess, document, and report compliance observations within required timelines • Follow up on action owners and ensure corrective and preventive action plans are implemented • Use GCC and RCC systems and tools to schedule and document compliance visits • Conduct peer review of site compliance visit reports • Monitor regulatory, industry, and company developments through training and professional forums • Support trend analysis, compliance dashboard development, and ongoing risk assessment • Provide performance feedback on CRAs and team members • Provide investigator site performance feedback for future study feasibility • Coach or mentor junior team members as needed • Support inspection readiness, preparation, hosting, response management, and lessons learned

🎯 Requirements

• Fluent English is required • Bachelor’s degree (BS/BA or equivalent) in a scientific, medical or healthcare discipline, with minimum 5 years of progressive experience in clinical operations roles for Manager level • Bachelor’s degree (BS/BA or equivalent) in a scientific, medical or healthcare discipline, with minimum 7 years of progressive experience in clinical operations roles for Senior Manager level • Minimum 4 years’ experience in a lead monitoring or trial oversight role • Minimum 2 years’ experience in a GCP compliance or equivalent role is preferred • Experience in oncology global trials is preferred • Understanding of clinical trial processes and thorough knowledge of ICH-GCP and associated regulatory guidelines • Analytical and problem-solving skills • Organizational, project management and leadership skills • Excellent English written and verbal communication and interpersonal skills • Ability to work independently in a multi-cultural setting and handle multiple priorities in a fast-paced environment • PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint) • Ability to travel up to 50–75%

🏖️ Benefits

• Full-time employment • Remote work in Brazil • Equal opportunity employment