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BeiGene

Manager, TMF Systems

Posted 5 Days Ago
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Remote
Hiring Remotely in US
124K-164K Annually
Senior level
Remote
Hiring Remotely in US
124K-164K Annually
Senior level
Manage and oversee eTMF processes, including system validation, data migration, and process optimization. Collaborate with teams for reporting and improvements while ensuring project deadlines are met.
The summary above was generated by AI

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.
Supervisory Responsibilities:  
  • Management of projects and ensuring resources on projects/tasks deliver on time.
  • Manage contractor resources and system analyst as required.
Computer Skills:   MS Excel, MS Word, MS Outlook, MS Visio, MS Project, Adobe AcrobatOther Qualifications:    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.
Travel:  <10%Education Required: Bachelor's degree with 5+ years of experience.

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

  • Fosters Teamwork
  • Provides and Solicits Honest and Actionable Feedback
  • Self-Awareness
  • Acts Inclusively
  • Demonstrates Initiative
  • Entrepreneurial Mindset
  • Continuous Learning
  • Embraces Change
  • Results-Oriented
  • Analytical Thinking/Data Analysis
  • Financial Excellence
  • Communicates with Clarity

Salary Range: $124,300.00 - $164,300.00 annually

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflects the base salary or hourly range only. 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 because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected].

Top Skills

Adobe Acrobat
Etmf
Excel
Ms Outlook
Ms Project
Ms Visio
Ms Word
Veeva Etmf System

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