TMF Specialist

Job Summary:

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

Job Description:

Supporting activities may include, but not be limited to:

Oversight & Support of Project Cycle

• Clinical System Administration
  • May act as Clinical System Business Administrator for user account management, study creation, and minor configuration updates
  • Maintain study expected documents and milestones configuration and management
  • Participate in validation activities related to major configuration updates and/or other clinical system integrations
  • Remain current on clinical systems new releases and features of TMF platform in use, as well as staying current with technology trends related to TMF management
• TMF Operations
  • Ensure TMF file structure is dynamic and reflective of current regulations and company work practices
  • Support TMF review process by working closely with study teams, CROs, and Vendors
  • Perform assigned TMF review actions in a timely manner
  • Provide Clinical Study Teams with relevant reports and outputs to support maintenance of TMF Health
  • Ensure periodic reviews are completed and determine additional quality reviews to promote continued quality improvement and user performance. Report trends to leadership
  • Support Clinical Study Teams in resolution of TMF-related queries or quality issues
  • Support TMF audits and inspections as required

• TMF Archiving
  • Prepare TMF records (electronic) for long-term (off-site) archival in compliance with client procedures, GCP and other relevant global regulatory requirements
  • Retrieve archived electronic TMF records as required
  • Perform quality checks and test retrievals of TMF records from electronic 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 CRO, Vendors, or partners on the policies and procedures relative to TMF management
  • Manage user requests/inquiries and maintain elements TMF guidance documents
  • Collaborative Relationship
  • Create and manage study TMF Plan in partnership with study team/Clinical Research Organizations (CROs)/Vendors, and perform vendor oversight activities
  • Foster positive relationships with external vendors and internal functional areas

Compliance with Parexel Standards

• Complies with required training curriculum
• Completes timesheets accurately as required
• Submits expense reports as required
• Updates CV as required
• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Skills:

• 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

• Deals comfortably with uncertainty of change

• Readily takes action on challenges, without unnecessary planning

• Experiments to find new solutions

• Maintains positive attitude despite adversity

• A team player

• Shows personal commitment and takes action to continuously improve

• Is seen as direct and truthful

• Is effective in a variety of communication settings: one-on-one, small, and large groups, or among diverse styles and position levels

• Represents own interests while being fair to others and their areas

• Proficiency in written and spoken English required

• Proficiency in local language as applicable

Knowledge and Experience:

• 5 years of TMF experience, including experience in study start-up, maintenance, and closeout activities as well as subject matter expertise with the TMF Reference Model, clinical trial activities and related terminology preferred

• Excellent working knowledge of the TMF Reference Model

• Excellent 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; Veeva Clinical experience preferred but not mandatory

• Experience working in GxP environment with validated systems

• Veeva Certification preferred

Education:

• Bachelor of Arts/Bachelor of Sciences or equivalent is preferred with related experience in pharmaceutical / biotechnology industry including records management experience in a GCP-regulated environment