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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

TMF processesdata migrationchange controlseTMF reportsTMF metricsproblem-solvingdocumentation

Soft Skills

collaborationinfluencedetail orientedorganizational skillsmulti-taskingcommunication