Tmf & Document Specialist

Oversee the handling of clinical trial documents in the Trial Master File (TMF) by ensuring adherence to quality standards, regulatory requirements, and Standard Operating Procedures (SOPs).
Essential Duties and Responsibilities

• Core Responsibilities:
  
  • Maintain and foster working relationships and open communication between departments
• Document Management in Clinical Trials:
  
  • Prepare and inventory files for off-site storage, if applicable
  • Participate in TMF audits including preparation and follow-up
  • Prepare inventories, assist with quality checks and reconciliation of files during the study and at study closure
  • Ensure the security and compliance of all documents related to active and archived projects
  • Receive and inventory applicable project documents in the TMF
  • Process, scan, index, route and maintain applicable project documents for the TMF in accordance with quality standards and relevant SOPs
  • Draft project specific TMF Plan and structure at the beginning of the trial as well as maintain and update TMF plan throughout the trial
• In-Process control in clinical trials:
  
  • Provide ongoing training/feedback to the team on topics related to Good Documentation Practices (GDP), ICH-GCP, pertaining to TMF and document management per study team requirements
  • Provide study team reports or updates regarding status of TMF on a regular basis

Job Related Qualifications/Skills
Professional Experience

• Required:
  
  • Experience in document management
  • Experience in electronic trial master file (eTMF)

Knowledge, Skills and Abilities

• Required:
  
  • Knowledge in clinical research and in the conduct of clinical trials
  • Knowledge in relevant regulations (ICH GCP, EU CTR, MDR, FDA, etc.)
  • Knowledge of Good Documentation Practices (GDP)
  • Knowledge of the preparation and processing of documents for clinical trials
  • Fluent (business) English
  • Excellent keyboard skills, with experience using Microsoft Office (Word, Excel, Power Point, Outlook) applications to prepare charts, tables, forms, reports, and presentations
  • Flexibility and ability to support various clinical trials and teams in parallel
  • Self-management skills

Education

• Required:
  
  • Education in life sciences or medical health or other comparable professional qualifications
• Preferred:
  
  • Bachelor's degree in life science or medical health

Additional information
Work Type:

• Remote

Annual Salary Range:

• $65,000 to $75,000

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)