Regional Clinical Study Manager

🔥 45 minutes ago

🇲🇾 Malaysia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 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

• 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 the regional clinical operations team and external regional partners • Serve as escalation point for regional study issues • Ensure regional deliverables align with overall study goals • Develop regional tools, work instructions, and SOPs • Lead planning and management of assigned 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 creation, maintenance, and quality control of country and site-level Trial Master Files • Provide input on regional drug inventories, labels, regulatory approvals, and comparator reimbursement status • Manage regional trial data collection, data entry, and query resolution • Support Clinical Study Report planning and execution • Monitor regional compliance with protocol, SOPs, ICH/GCP, and applicable regulations • Ensure inspection readiness and prepare sites for audits and inspections • Drive responses to audit and inspection findings • Lead process improvements and development/review of work instructions and SOPs • Select and manage regional study vendors • Manage regional study budgets and investigator/site payment activities • Identify regional resource needs and monitor resource utilization • Provide performance feedback, mentor junior team members, and potentially take on line management responsibilities

🎯 Requirements

• Bachelor’s Degree in a scientific or healthcare discipline required • Exceptions might be made for candidates with relevant clinical operations experience • 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 is preferred • MS Office proficiency • Project Planning Applications proficiency • Travel might be required as per business need

🏖️ Benefits

• Market competitive compensation package including performance-based annual bonus scheme • Company shares (generous welcome grant!) • In-house and external learning and development opportunities • Fantastic benefits program • Dynamic, collaborative, supportive, inclusive, and fun team environment