Global Study Management Associate

🕒 October 28

🇺🇸 United States – Remote

💵 $72.8k - $97.8k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

👻 Ghost score 1%

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• Open for 16 days.
• Jobs at this company usually fill in 41 days.

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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 expectations • Support alignment of study goals with clinical operations objectives • Support organization and logistics for cross-functional Clinical Study Team meetings • Collaborate with Global Clinical Study Manager, Regional Clinical Trial Management Associates, and global and regional stakeholders • Create and maintain study-level SharePoint resources and CST distribution lists • Set up studies in systems such as eTMF and CTMS and keep study information current • Manage study-system access and user accounts throughout the study lifecycle • Support development of study plans and organization of investigator meetings • Support site feasibility assessments • Track study deliverables including screening, enrollment, biological samples, images, data flow, and protocol deviations • Prepare management metrics and updates • Support study newsletters and study-conduct correspondence • Support study-level TMF creation, maintenance, document review, and quality control • Support study drug forecasts and supply activities • Support data cleaning and follow-up of outstanding information • Support planning and execution of Clinical Study Reports • Identify operational risks and issues and recommend solutions • Suggest improvements to enhance efficiency and quality • Support vendor selection and setup for global outsourced activities • Support study budget management, purchase-order setup, and invoice tracking

🎯 Requirements

• Bachelor or higher degree in a scientific or healthcare discipline required; higher degree preferred • Exceptions might be made for candidates with relevant clinical operations experience • 1 or more years of experience in clinical research within Biotech, Pharma or CRO industry • Knowledge of clinical operations methodologies and 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 • Limited travel might be required

🏖️ 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

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