Manager, TMF Systems

🕒 March 17

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Logo of BeOne Medicines

BeOne Medicines

10,000+ employees

Founded 2010

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.

📋 Description

• Work with supervisor to execute multiple, highly complex TMF processes in relation to the global eTMF system and Global TMF roadmap • Manage validation of the eTMF system for change controls, data migration as well as integration • Oversee operational aspects of eTMF including support tickets, access requests • Create new processes using various tools, to improve system and business processes • Assist in the creation and maintenance of eTMF reports and dashboards as required • Utilize eTMF tools, dashboards, and technology to analyze TMF metrics, and to communicate with study teams, peers, and system end users on actions required • Communicate and actively collaborate with managers and leaders concerning the TMF processes, eTMF system, and pending inquiries • Attend and participate in department meetings, and end user forums to develop increased knowledge and application of system tools, to improve business processes

🎯 Requirements

• 5+ years of experience in the pharmaceutical industry • 3+ years of TMF experience • 3+ years minimum working in Veeva eTMF System (Clinical Vault) • Ability to execute and follow‐through to completion and documentation • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view • Independently motivated, detail oriented and good problem-solving ability • Excellent organizational skills, sufficient to multi‐task in an extremely fast‐paced environment with changing priorities • Excellent communication skills and ability to influence across multiple functions.

🏖️ Benefits

• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness

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