06 set - Milano
BoehringerPRD
The Position
Accountable for the operational management of the regional/local component of a clinical trial. Level of oversight assures achievement of trial recruitment commitment, timelines, budget and internal/external quality standards.
Tasks and responsibilities
Lead and support regional/local trial team to ensure sites readiness.
Where necessary, set up and manage external suppliers that meet requirements of regional/local trial operations interacting with local clinical operations teams if needed.
Set up, manage and review Regional and Local trial budget to ensure appropriate level of financial oversight. Timely budget updates based on trial changes.
Ensure appropriate trial-specific training of Regional and Local internal and external partners in line with Trial Training Plan.
Provision of appropriate trial oversight for the trials by monitoring compliance of trial sites and the company team, local regulations, company SOPs (for our staff and issues), and adherence to trial protocol.
Adequate trial supply distribution to sites.
Continuous and timely data entry and cleaning, and on time Database Lock.
Ensures collection of required documents, with timely, complete and compliant archiving of all relevant documents.
Requirements:
Degree in Health Sciences or related fields.
Over 8 years of experience in pharmacological clinical research as a CRA and Project Manager.
Advanced level of English.
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