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 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 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: