Regional Clinical Trial Management Associate

🔥 15 hours ago

🇺🇸 United States – Remote

💵 $72.8k - $97.8k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚫👨‍🎓 No degree required

👻 Ghost score 1%

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Logo of BeOne Medicines

BeOne Medicines

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 Regional Clinical Study Manager in regional study delivery and delegated clinical study components • Support Clinical Research Associates and Study Start-up Specialists in country study delivery • Support clinical trial conduct, including feasibility assessment, study start-up, document generation and review, sample tracking, and participant enrollment • Support CTMS updates, ISF binder preparation, document collection, ICF customization, and eTMF maintenance • Interpret and implement regulations and ICH guidelines • Set up regional and country team meetings, agendas, and minutes • Maintain SharePoint folders, distribution lists, eTMF, CTMS, and other study systems • Support system access requests and user account management • Support study start-up, investigator meetings, TMF creation, review, and quality control • Help resolve regional or country clinical supply issues and support data cleaning • Prepare site newsletters and clinical trial correspondence • Support public registry information maintenance and Clinical Study Report inputs • Support operational risk identification, audits, inspections, tools, work instructions, and SOPs • Support vendor setup, regional study budgets, purchase orders, payments follow-up, and accrual activities

🎯 Requirements

• 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 • MS Office, eTMF, CTMS • Preferably Bachelor’s Degree, preferably in a scientific or healthcare discipline required • Limited travel might be required • Exceptions might be made for candidates with relevant clinical operations experience

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Incentive compensation plan eligibility for commercial roles • Discretionary equity awards • Voluntary Employee Stock Purchase Plan participation • Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness

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