• Location: Cambridge, MA
• Type: Temporary
• Job #5012

Headquartered in Cambridge, Mass., our client employs 1,400 people in 19 countries and is rapidly growing globally, and is proud to have been recognized as one of The Boston Globe’s Top Places to Work five years in a row (2015-2019), a Great Place to Work in the U.K. and Switzerland in 2020 and Science Magazine’s #1 Top Employer in 2019.

Overview

The TMF Specialist is responsible for supporting a high quality TMF, performing quality checks, archival and retrieval of records for the Trial Master Files (TMF). Responsibilities include but are not limited to driving and overseeing successful completion of all TMF deliverables such as TMF Business Administration tasks, TMF Plan development, TMF set-up and QC review activities, and archiving.

Summary of Key Responsibilities

TMF Administration

• May act as eTMF Business Administrator for user account management, create and promote studies in the eTMF, and unblinding
• Manage askTMF mailbox and maintenance of an FAQ log
• Support Study EDLs and Milestones configuration and management TMF Quality
• Create and manage Study TMF Filing plan with input from Study team
• Support TMF review process by working closely with study teams, CROs and Vendors
• Perform assigned TMF review actions in a timely manner
• Provide Study teams with relevant reports and outputs to support TMF Quality
• Ensure Inspection Readiness review of TMF is completed and documented
• Support study teams for resolution of TMF-related queries or quality issues
• Support TMF audits and inspections as required

Paper TMF

• Set-up TMF paper folders, as applicable
• Manage TMF inventory trackers
• Prepare for receipt of CRO’s portion of the TMF
• Process the CRO’s portion of the TMF in a timely and controlled manner
• Manage, track and document TMF records received, filed, archived, retrieved, transferred and destroyed in compliance with company policies

TMF Archiving

• Prepare TMF records (paper and electronic) for long-term, off-site archival in compliance with company procedures, GCP and other relevant global regulatory requirements
• Retrieve archived TMF records as required
• Perform quality checks and test retrievals of TMF records from long-term archival; document any findings and follow to resolution or escalation in compliance with company procedures, GCP and other relevant global regulatory requirements

Process Improvement and Training

• Communicate TMF process improvement suggestions to relevant stakeholders
• Support and/or deliver training across the Company, CRO and Vendors on the policies and procedures relative to and for TMF management
• Foster positive relationships with external vendors and internal Expertise Areas

Qualifications

• Bachelor’s Degree or equivalent with demonstrable related experience in pharmaceutical / biotechnology industry including records management experience in a GCP-regulated environment
• Good working knowledge of the TMF Reference Model
• Good knowledge of Good Clinical Practices (GCP), regulations/guidelines and of the auditing process and compliance requirements in relation to TMF
• Experience of electronic document management system(s) and eTMF with Veeva eTMF experience preferred but not mandatory
• Ability to work in a team environment as well as independently
• Proficient in common office technology e.g. Microsoft tools, teleconferencing, etc.
• Ability to handle a high volume of complex tasks within a given timeline
• Clear alignment with Company Core Value

Our client company is an EEO employer committed to an exciting, diverse, and enriching work environment.