Senior Regional Clinical Trial Management Associate

🔥 3 minutes ago

🇺🇸 United States – Remote

💵 $83.8k - $113.8k / year

⏰ Full Time

🟠 Senior

👻 Ghost score 1%

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

• Support the Regional Clinical Study Manager in regional study delivery and delegated clinical study components • Support Clinical Research Associates and/or Study Start-up Specialists in country study delivery • Apply knowledge of clinical trial operations and support alignment of regional deliverables with overall study goals • Support regional vendor management and other regional study management activities • Participate in internal working groups and initiatives • Serve as a subject matter expert in a specific process and potentially mentor team members • Support 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 • Support monitoring visit preparation, equipment management, contract activities, regulatory submissions, TMF filing, and SUSAR submissions • Create and maintain SharePoint folders, distribution lists, and country/site records in eTMF and CTMS • Support system access and user account management throughout the study lifecycle • Support local adaptation and review of study-related documents • Support investigator meetings, TMF creation and quality control, clinical supplies issues, data cleaning, site communications, and routine site questions • Support public registry information maintenance and Clinical Study Report input • Support operational risk identification, quality assurance audits and inspections, process improvements, tools, work instructions, and SOPs • Support vendor selection, regional study budgets, purchase orders, payments follow-up, and accrual activities

🎯 Requirements

• Preferably bachelor's degree, preferably in a scientific or healthcare discipline required; higher degree preferred • Exceptions might be made for candidates with relevant clinical operations experience • 2 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 proficiency • 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 benefits