Manager, TMF Systems

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

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 Acrobat
Other 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

Travel:

Education Required

Bachelors degree with 5+ years of experience.
Salary Range

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

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

BeOne is a proud 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 View email address on click.appcast.io.

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