The purpose of this contract is solely for trial master file (TMF) review and reconciliation.
The CTA must have extensive TMF experience – Preferably using the Phlexglobal System which Client uses. Minimum 2 years relevant experience preferred.
What does extensive experience mean?
1. Understand the filing plan and perform logic checks to make recommendations to the study manager to add or remove placeholders as appropriate
2. Document knowledge – They must understand the key documents and not just recognize that there is a document in the placeholder. This also includes expertise in knowing which documents correlate to other documents. Eg. CVs, medical licenses, financial disclosures should match what is written on the 1572, all present, accurate and up to date
3. Global expertise – Understand what is required for country level and site levels in the different countries and do logic checks
4. Study level – Trial level, country level and site level expertise. For the Trial level this includes expertise in knowing which documents are required for each department; Data Management, Statistics, Safety, DSMB, etc.
Client training will be provided:
TMF related SOPs
Training by TMF group
Understanding of which documents are stored outside Phlexglobal
Study Manager will be assigned to support and answer questions
Source: Job Diva – Job Listing