TMF Lead II - Remote

Overview

The TMF Lead II is responsible for oversight, management, and delivery of the eTMF in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Precision Standard Operating Procedures (SOPs) as appropriate. The TMF Lead II supports smaller and/or less complex studies.

In Short

• Creates and executes the study TMF Plan and project TMF Document Index.
• Ensures entire study team understands expectations and manages communication of any changes in the TMF.
• Attends and contributes to project internal meetings to ensure awareness of the eTMF status.
• Engages with Project Manager and Functional Leads for timely TMF documentation submission.
• Monitors and reports on TMF Health to internal team and sponsor.
• Initiates and performs Quarterly Completeness/Compliance checks for assigned projects.
• Identifies project team TMF training needs and provides support.
• Supports close-out activities of assigned studies.

Requirements

• 4-year college degree or equivalent experience in business, scientific or healthcare discipline.
• At least 1 year of experience with TMF and/or eTM.
• Established experience in Microsoft Office (Outlook, Word, Excel, PowerPoint).

Benefits

• Discretionary annual bonus.
• Health insurance.
• Retirement savings benefits.
• Life insurance and disability benefits.
• Parental leave.
• Paid time off for sick leave and vacation.