Clinical Trial Manager
hace 7 días
The CTM manages assigned clinical trials, leads the FSE trial teams in order to ensure highquality execution of the trials and deliverables within all countries in the FSE.
The CTM enables the Adjacent Affiliate teams to deliver clinical trials in the shortest possible time in accordance with the sponsor policies and procedures, SOP's, local legislation and GCP requirements.
What you will be doing:
Overall project management of assigned clinical trials in the FSE and adjacent affiliatesResponsible for deliverables and high-quality execution of clinical trials in the FSE and adjacentaffiliatesLeading the FSE trial teamsPlanning, executing, coordinating tasks and communicating between relevant roles, such as FSE CTA and CRAs in adjacent affiliates and global trial management, to facilitate the progress of the trialAttending all trial related meetings / TCs and ensuring knowledge sharing across the FSE trial teamProactive risk identification and executing mitigation plans at the FSE level and adjacent affiliatesEnsuring successful start-up of clinical activities in the FSE and adjacent affiliates (all trial related documents review, CTA dossier oversight, ensure timely HA/EC submission/approval, ensure materials for site initiation / selection, e.
G. preparing presentations)
Responsible for trial budgets (ClinCost):
preparation and tracking in the FSE and adjacent affiliatesExecute and follow up on Recruitment and Retention plans at the FSE level and adjacent affiliatesPerform Visit Report review (all type of visits)Conduct co-monitoring visits across the FSECTMS set-up & update at country level (for adjacent affiliates)Oversight and compliance check of STMF (nD/Veeva) for assigned clinical trials in close collaboration with FSE CTASupervise clinical supplies' processes in the FSE and adjacent affiliates, e.
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