Management of eTMF including document filing, quality and completeness checks, set-up and maintain relevant trial logs in eTMF, maintain and archive STMF, management of CTMS (RDA role).
Manage orders and distribution of supplies, management of all trial documentation for assigned clinical trials. Management of clinical affiliate stock. Prepare and collect information to purchase orders.
Provide Investigator Trial Master Files to Affiliates/sites (coordination of ITMFs preparation process and additional patient material distribution including the vendor management)
Support in the organisation of local investigators’ meetings (SRR), support in invoice management, support orders of supplies, support office orders and support affiliate clinical meeting planning and organize meetings.
Set-up and maintain relevant investigator and 3rd party vendor logs at Clinical department.
Qualifications
Master’s degree in Life Sciences or equivalent would be considered an advantage.
Preferably min. 1 year experience in administrative roles within clinical operations.
Fluent in Bulgarian and in English – oral and written.
IT knowledge: MS Office, MS Excel.
Ability to cooperate within a team, ability to support a team, build and maintain strong working relationships with internal stakeholders, work in a structured and pro-active manner as well as part of a team, manage priorities.
Team oriented personality with high degree of flexibility - close collaboration with relevant roles to ensure successful administrative deliverables.
