Manager, Regional Clinical Compliance, GCP

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $118.6k - $158.6k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 1%

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 and track non-compliance issues, quality events, potential misconduct and potential Serious Breach • Track and trend observations from Site Compliance Visits to identify issues and risks across study programs and processes • 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 and integrity, classify observations, and escalate GCP non-compliance issues • Complete and peer-review on-site and remote compliance visit reports • Follow up on observations and ensure corrective and preventive action plans are implemented • Use GCC and RCC systems and tools to schedule and document compliance visits • Stay current on government, industry and company regulations through trainings, conferences, workshops and discussion groups • Support trend analysis, compliance dashboards and ongoing risk assessments • Provide performance feedback on CRAs and team members to line managers • Provide investigator site performance feedback for future study feasibility • May coach or mentor junior team members

🎯 Requirements

• Bachelor’s degree (BS/BA or equivalent) in a scientific, medical or healthcare discipline with minimum of 5 years of progressive experience in clinical operations roles • Minimum 2 years’ experience in a GCP compliance or equivalent role is preferred • Minimum 4 years’ 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 handle multiple priorities in a fast-paced environment • PC literacy required • MS Office skills (Outlook, Word, Excel, PowerPoint) • Up to 50–75% travel • Experience in oncology global trials is preferred

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Incentive compensation plan eligibility for commercial roles • Discretionary equity awards • Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness