eTMF Specialist

The primary responsibility of the (e)TMF Specialist is to provide support for electronic Trial Master File [(e)TMF] activities. This role will be responsible for document quality control (QC) and review of documents in the (e)TMF. The (e)TMF Specialist will assist teams with scanning and uploading tasks, as needed.

The (e)TMF Specialist Will

• support the filing of clinical documents into the trial master file, including paper and electronic filing.
• perform QC of documents submitted in the (e)TMF using established acceptability criteria.
• support internal functions and external vendors with facilitation of document upload into the (e)TMF, ensuring that clinical team has consistency in review of files and are maintained across all studies.
• address (e)TMF questions pertaining to how documents are filed, and user questions related to the (e)TMF system.
• assist with capturing identified (e)TMF metrics.
• perform (e)TMF archiving tasks, as needed.
• develop and maintain strong working relationships with both internal and external collaborators and stakeholders across all geographical regions.
• maintain up to date knowledge of the (e)TMF reference model, industry best practices and regulatory considerations as applicable to the job duties.
  
  

The ETMF Specialist Will Have

• required knowledge and experience in eTMF system
• required knowledge in TMF requirements as per regulations and ICH GCP requirements.
• demonstrated ability to work in a fast-paced team environment.
• drive, energy and enthusiasm to deliver objectives.
• understanding of tasks involved in a clinical development and operations (i.e. protocol to final clinical study report) and impact to filing into the (e)TMF and associated filing structure.
• the ability to evaluate and make recommendations regarding staff eTMF management activities.
• the ability to assist in teaching/coaching and setting an example of ‘best practice’.
• excellent interpersonal, written and oral communication skills.
• current computer literacy in appropriate software.
  
  

The ETMF Specialist Will

• 4 year undergraduate degree
• 2 years clinical research experience
• have previous experience in handling clinical trial related documents.
• have an understanding of the clinical trial process.
• Have comprehensive knowledge of GCP guidelines and its applicability to all stages of the clinical development and operations process.