Manager, Regional Clinical Compliance

🔥 1 minute ago

🇧🇷 Brazil – 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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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/or site levels • Provide independent compliance oversight and quality support to BeOne GCO study teams • Maintain appropriate study conduct, inspection readiness and compliance with applicable regulatory requirements • Identify, escalate, track and trend non-compliance issues, quality events and potential misconduct or Serious Breach • Support development of GCP readiness activities and programs • Contribute to development and review of Clinical Operations work instructions and SOPs • Provide GCP compliance guidance and support for assigned study portfolios • Conduct remote compliance reviews and periodic risk evaluations • Plan and conduct Site Compliance Visits at investigator sites • Evaluate site practices and integrity, classify observations and share visit outcomes • Complete compliance visit reports within specified timelines • Follow up on observations and corrective and preventive action plans • Use GCC and RCC systems and tools to schedule and document compliance visits • Conduct peer reviews of site compliance visit reports • Stay current on government, industry and company regulations, trends and interpretations • Support trend analysis, compliance dashboard development and ongoing risk assessment • Provide feedback on CRA and team member performance and investigator site performance • Support inspection readiness, preparation, hosting, response management and lessons-learned development • May coach or mentor junior team members • Travel up to 50–75%

🎯 Requirements

• Fluent English is required • Bachelor’s degree (BS/BA or equivalent) in a scientific, medical or healthcare discipline • Manager level: minimum 5 years of progressive experience in clinical operations roles • Manager level: minimum 2 years’ experience in a GCP compliance or equivalent quality role preferred • Manager level: minimum 4 years’ experience in a lead monitoring or trial oversight role • Associate Manager level: minimum 4 years of progressive experience in clinical operations roles • Associate Manager level: minimum 6 months’ experience in a GCP compliance or equivalent quality role preferred • Associate Manager level: minimum 1 year of experience in a lead monitoring or trial oversight role • 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 • Excellent organizational skills and ability to prioritize and multi-task • Ability to work independently in a multicultural setting and effectively handle multiple priorities in a fast-paced environment • PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint) • Preferred experience in the pharmaceutical/biotech industry • Experience in oncology global trials preferred • Candidates must submit resumes/CVs in English

🏖️ Benefits

• Equal opportunity employer • Up to 50–75% travel associated with the role