Senior Manager, CDM Systems Administrator

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September 30

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BeOne Medicines

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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 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.

10,000+ employees

Founded 2010

📋 Description

• Lead and provide oversight of Data Management systems including Oracle LSH/DMW, Medidata Rave and systems onboarded to the data management department • Accountable for the management and development of EDC Administrator team • Support EDC admin activities as well as LSH/DMW activities • Manage user, site and subject administration support to clinical applications utilized by Clinical Data Management group • Collaborate with R&D data governance groups and IT groups in implementation of MDM and downstream processes impacting data management systems • Develop and maintain user access management documents to maintain compliance • Function as an EDC Systems Support SME providing guidance and best practices to DM, Clinical teams and other cross functional groups • Resolve and escalate user access issues, tool issues, testing needs, and enhancement requests • Contribute to integration of different clinical systems to enhance efficiencies and data quality • Provide EDC technical support to facilitate clinical study timelines and deliverables • Support development, review and approval of systems-related documentation • Oversee EDC Administrator role to support Study Set Up, Study Maintenance, Study Conduct and Study Close Out operational deliverables • Conduct User Acceptance Testing on EDC system version upgrades, patches and integrations • Support technical systems access requests for all users including outsourced trials, CROs and offshore partner resources • Provide oversight of Help Desk Support Management as internal escalation point • Perform all other related duties as assigned

🎯 Requirements

• Bachelor’s degree in engineering or biotech industry • 7+ years’ experience in biotech/pharmaceutical environment • Minimum of four years in management role and functional leadership • Fluent in English both for verbal and written • Ability to work independently, under pressure meeting tight deadlines, demonstrating high level of initiative and flexibility • Excellent organizational and analytical skills • High attention to detail and accuracy • Proven problem-solving skills • Demonstrated knowledge of clinical and pharmaceutical drug development process • Experience of clinical databases, clinical data management systems and electronic data capture (EDC) • Knowledge and understanding of clinical database design / study build / data validation and system interoperability • Competence with project management skills • Excellent communication and interpersonal skills • Demonstrated ability to work effectively with internal groups and external partners • Ability to work in a global team environment • Ability to interact effectively with all levels of management • Computer Skills: Advanced • Experience with Oracle LSH/DMW and Medidata Rave (EDC systems) • Travel: None to Minimal

🏖️ Benefits

• Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan • All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock (discretionary equity awards) • Employee Stock Purchase Plan • Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness