Regional Clinical Study Manager

🔥 17 hours ago

🇺🇸 United States – Remote

💵 $136.4k - $181.4k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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

• Accountable for regional study delivery with inspection readiness quality, within agreed timelines and budget • Act as regional lead for multiple studies across an indication or program • Lead regional clinical operations teams and external regional partners • Serve as escalation point for regional study issues • Align regional deliverables with overall study goals • Develop regional tools, work instructions and SOPs • Lead regional planning and management of clinical studies from feasibility through closeout • Manage study start-up and recruitment timelines and track progress • Drive trial feasibility, country allocation and site selection • Coordinate local adaptations of global study documents and regulatory/ethics submissions • Maintain regional and country information in study systems • Collaborate with CRAs to ensure study execution and review monitoring reports • Ensure regional and country-level Trial Master File creation, maintenance and quality control • Provide input on clinical supplies, drug inventories, labels and comparator drug status • Manage regional data collection, data entry and query resolution • Support Clinical Study Report planning and execution • Monitor compliance with protocol, SOPs, ICH/GCP and applicable regulations • Ensure inspection readiness and prepare sites for audits and inspections • Lead quality improvements and share best practices • Select and manage regional vendors • Manage regional study budgets • Address investigator fees, site payments and patient travel reimbursement • Manage regional resource needs and utilization • Provide performance feedback and mentor junior team members

🎯 Requirements

• Bachelor’s Degree in a scientific or healthcare discipline required • Higher Degree preferred • 6 or more years of progressive experience in clinical research within biotech, pharma or CRO industry • Proven experience in clinical research, including relevant experience as team lead in clinical functions • Experience as CRA preferred • MS Office proficiency • Project Planning Applications proficiency • Relevant clinical operations experience may qualify for exceptions to the degree requirement • Travel might be required as per business need

🏖️ 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 benefits • Reasonable accommodation during the application process