Senior CTMA Manager, Regional Clinical Study Management

🔥 3 hours ago

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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

• Line manage Clinical Trial Management Associate (CTMA) team members • Plan, assign, and direct work; assess performance; and guide professional development of direct reports • Lead selection, hiring, and allocation of resources to clinical research projects • Assign staff to clinical studies based on experience and training • Lead process improvements, best practices, and lessons learned sharing • Lead study teams with Clinical Operations tasks • Support compilation and quality of the trial master file (eTMF) • Conduct 1:1 meetings and performance reviews with direct reports • Interview and onboard new hires and ensure team training and SOP adherence • Coordinate and balance workload and review quality metrics • Manage and maintain CTMA resourcing tools • Contribute to Clinical Operations strategy, performance metrics, and process improvement activities • Provide Clinical Operations support to cross-functional study teams from start-up through close-out • Assist with clinical trial documents, manuals, trackers, informed consent development, and version tracking • Prepare agendas and minutes for internal and external meetings • Maintain clinical operations tools such as CTMS, EDC, and IRT • Contribute to eTMF setup, maintenance, and close-out • Perform other duties as assigned

🎯 Requirements

• Solid leadership and management experience as a direct line manager or cross-functional team lead • Advanced clinical operations knowledge • Strong organizational skills • Experience with ICH/GCP, local regulations, SOPs, and Clinical Operations Work Instructions • Ability to support clinical trials and cross-functional clinical study teams • Proficiency with MS Office and project planning applications • Strong written and verbal communication skills • Sound judgment and discretion in significant matters • Ability to work independently and handle multiple priorities in a fast-paced environment • Excellent interpersonal skills and ability to influence and lead • Travel may be required according to business needs

🏖️ Benefits

• Annual bonus plan eligibility for non-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