Manager, TMF Systems

BeiGene

1d

About The Position

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General 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. Creates new processes using various tools, to improve system and business processes. Assists in the creation and maintenance of eTMF reports and dashboards as required. Utilizes eTMF tools, dashboards, and technology to analyze TMF metrics, and to communicate with study teams, peers, and system end users on actions required. Communicates and actively collaborates with managers and leaders concerning the TMF processes, eTMF system, and pending inquiries. Analyze and report metrics as required. Attends and participates in department meetings, and end user forums to develop increased knowledge and application of system tools, to improve business processes. Able to accomplish tasks with a focus on data integrity/quality without supervision. Essential Functions of the Job: Assist and lead data migrations/transfers and integrations working with IT and other internal and external stakeholders. Assist with UAT processes and documentation. Lead activities related to improvements for eTMF dashboard and metrics.

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.
• Bachelor's degree with 5+ years of experience.

Responsibilities

• 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.
• Creates new processes using various tools, to improve system and business processes.
• Assists in the creation and maintenance of eTMF reports and dashboards as required.
• Utilizes eTMF tools, dashboards, and technology to analyze TMF metrics, and to communicate with study teams, peers, and system end users on actions required.
• Communicates and actively collaborates with managers and leaders concerning the TMF processes, eTMF system, and pending inquiries.
• Analyze and report metrics as required.
• Attends and participates in department meetings, and end user forums to develop increased knowledge and application of system tools, to improve business processes.
• Assist and lead data migrations/transfers and integrations working with IT and other internal and external stakeholders.
• Assist with UAT processes and documentation.
• Lead activities related to improvements for eTMF dashboard and metrics.

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness
• opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level