
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.
🔥 13 hours ago
🇺🇸 United States – Remote
💵 $108.7k - $143.7k / year
⏰ Full Time
🟠 Senior
🧪 Clinical Research
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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.
• Assign and/or drive all aspects of clinical trial data management activities from study start-up through database lock • Ensure the quality of all data reviewers’ deliverables • Support and work closely with study lead data managers for assigned clinical studies • Perform data cleaning and reconciliation activities according to company procedures and study-specific data management documents • Manage queries on assigned clinical studies • Generate and deliver reports to study team members • Support external data reconciliation and serious adverse event reconciliation • Review and reconcile laboratory data and associated lab normal ranges when applicable • Support creation and maintenance of data management documentation, including Data Management Plans and eCRF Completion Guidelines • Ensure data management documents are filed according to company SOPs and Work Instructions • Support development of eCRF and edit check specifications • Work with database builders on clinical database builds and programming of eCRFs, edit checks, and reports • Participate in User Acceptance Testing for clinical database builds, modifications, data transfers, and programmed report outputs • Assist with site and user management in clinical databases • Potentially lead Phase I to Phase II studies under manager supervision • Drive data review activities and identify and escalate potential data issues • Work with vendors such as central laboratories on timelines and data-related deliverables • Help identify and troubleshoot operational problems using metrics data, audit reports, and project team input • Mentor and train study team members on eCRFs and EDC • Support development and maintenance of data management SOPs and Work Instructions • Perform other duties as assigned
• 5+ years of experience in clinical data management in the pharmaceutical/biotechnology industry • Oncology experience preferred • Ability to work in cross-functional team-oriented environments • Understanding of ICH and the regulatory environment as it pertains to data management • Good understanding of data management and phases of clinical trials • Strong communication skills and ability to solve issues independently • Strong project management skills • Excellent written, verbal, and organizational skills • Good interpersonal skills and capability to lead study data reviewers and prioritize data management activities • Detail-oriented • Proficient computer skills, including Microsoft Office applications • Working knowledge of at least one EDC system; Medidata Rave preferred • Ability to travel domestically and internationally as required • Bachelor’s degree or equivalent in a health-related field preferred
• 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 insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness program
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