Senior Global Study Management Associate

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $83.8k - $113.8k / year

⏰ Full Time

🟠 Senior

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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

• Support the Global Clinical Study Manager in global study delivery and execution of delegated clinical study components within quality, timeline, and budget requirements • Support alignment of study goals with clinical operations objectives • Support study vendor management and other assigned study management activities • Support organization and logistics for cross-functional Clinical Study Team meetings • Collaborate with the Global Clinical Study Manager, Regional Clinical Trial Management Associates, and global and regional stakeholders • Contribute to task force initiatives, cross-functional projects, process improvement, standardization, and implementation activities • Create and maintain study-level SharePoint sites and Clinical Study Team distribution lists • Set up studies in eTMF, CTMS, and other systems and maintain study-level information • Manage study system access and user accounts across the study lifecycle • Support development and review of study plans and study-related documents • Organize investigator meetings under supervision • Support site feasibility assessments • Track study deliverables including screening, enrollment, biological samples, images, data flow, and protocol deviations • Prepare management metrics and updates on key deliverables • Support study newsletters and study-conduct correspondence • Support study-level TMF creation, maintenance, document review, and QC • Support study drug forecasting and supply activities • Support data cleaning and follow-up of outstanding information • Support planning and execution of the Clinical Study Report • Identify operational risks and issues and recommend solutions with the Global Clinical Study Manager • Share best practices and suggest improvements to enhance efficiency and quality • Support development of global study tools, work instructions, and SOPs • Support vendor selection and setup for outsourced global activities • Support study budget management, PO setup, and payment invoice tracking • Potentially mentor junior team members and onboard new hires

🎯 Requirements

• Bachelor or higher degree in a scientific or healthcare discipline; higher degree preferred • Exceptions might be made for candidates with relevant clinical operations experience • 3 or more years of experience in clinical research within Biotech, Pharma or CRO industry • Knowledge of clinical operations methodologies • Understanding of operational aspects of clinical study processes • Knowledge of clinical study operations, including interpretation and implementation of regulatory and ICH-GCP guidelines • Proficiency in MS Office Suite, including Excel, PowerPoint and Project • Ability to support global clinical study management, vendor management, study planning, quality, compliance, and budget activities

🏖️ 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 • Limited travel might be required

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