Trial Master File Associate

TFS HealthScience • Auburn, ME

2d • Remote

About The Position

As part of our CDS Ophthalmology Trial Master File team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.

The Trial Master File Associate is is part of the TMF Delivery Business Line within Clinical Development Services (CDS) and will function operationally as a member of the Study Team with the responsibility to organize, maintain and oversee the Trial Master File (TMF) according to company policies, SOPs, Work Instructions, regulatory requirements, TMF Functional Lead and PM delegation.

Requirements

• At least 1-5 year of experience in CRO or Pharmaceutical Industry with proven TMF Management.
• No less than 3 years of TMF experience (mandatory) with 1+ years of OPH experience (ideal)
• Bachelor’s Degree in Health Science or Document Management or equivalent work experience is preferred
• Knowledge of GCP/ICH guidelines
• Good written and communication skills
• Good organizational and multi-tasking skills
• Good software and computer skills
• Able to work in a fast-paced environment with changing priorities
• Teamwork ability
• Effective time management

Responsibilities

• Notify study team that TMF is created and ready for document upload for eTMF or submission to pTMF
• Develop TMF Plan
• Provide training on study specific TMF requirements, guidelines including TMF Plan
• Perform QC2 on documents and documents reconciliation
• Provide TMF Monthly Reports to PM, Line manager and Head of TMF Delivery
• Regularly check TMF metrics, follow up on detected issues, ensure acceptable level of metrics
• Ensure TMF processes timely implementation and execution
• Adjusting study specific TMF Index/EDL in the relevant files/ system as directed by the PM (Project Manager)
• Ensure valid forms and templates are implemented and maintained in the assigned projects
• Check status of duplicates, documents in error, size and path length (if applicable), follow up on necessary corrections accordingly
• Coordinate Monthly and Quarterly TMF Reconciliation by creating Action Plan and submitting relevant report on the status
• Ensure TMF AoR completion and monitoring TMF transfer/shipment to the Sponsor
• Ensure delivery of fully executed TMF AoR to TMF Functional lead
• Actively follow up that the study team is submitting documentation, EDL maintenance for eTMF in cooperation with study team, following the process described in The TMF Plan and that the TMF is always submission and inspection ready
• Act as contact person for study team to support on all TMF issues/inquiries independently
• Identify general areas with missing documentation and inconsistencies and follow up with the study team for resolution
• Actively taking part in Study Team meetings and updates on the TMF status
• Assist and attend activities associated to quality controls, audits and regulatory inspections in relation to the TMF
• Identify TMF quality issues and escalate to the CRM/PM/Director, TMF Functional lead and collaborate in the action plans development
• Resolve in cooperation with Study team all issue identified by Sponsor after TMF transfer
• Set up the Investigator Site File (ISF)
• Actively contribute to the organization and development of routines to enhance the work at TFS
• Develops and maintains an effective relationship with the study teams
• Other, as identified by Line Manager

Benefits

• We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment.
• You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 501-1,000 employees