Description
Mission Description:Support clinical trial supply related activities during the set-up, maintenance, return/destruction and archiving process, in collaboration with Clinical Supply Managers, other CTS functions, QA and Clinical, in compliance with quality and timeline requirements.
Scope: All projects and clinical trials (phase 1-4) performed under the responsibility of Global Clinical Development and GMA, including NPP.
Products: All in-scope products of UCB.
Mission responsibilities:
-Support Clinical Supply Management functions (ACSM, CSM, CSPM): Associate Clinical Supply Manager, Clinical Supply Manager, Clinical Supply Project Manager
-Creation and coordination of trial documentation (Core/Country label text (etiquettes), SSO (Study Supplies Overview), RCTA, Pharmacy/Return Manuals, etc.)
-System maintenance for trial documentation and activities (EPPM, Sharepoint, etc.)
-Monitoring of patient status/IMP stock consumption in IRT
-Creation and tracking of shipments to depots/sites
-Clinical support for assigned on-going trials, as appropriate
-Temperature excursions management, internally and with Clinical sites/CRAs
-Coordination of IMP returns/destruction, with Clinical, CTSO and distribution vendors
-Filing and archiving of trial documentation
-Suggest/contribute to/lead CTS process improvement initiatives
-Understanding of clinical trial/IMP Regulatory requirements.
Specific professional/technical expertise and key skills required:
-Soft skills:
"Excellent teamwork, customer focus and patient centricity/accountability (partly responsible for availability of patient treatment)
"Ability to work with limited supervision in support of multiple on-going trials (need to prioritize, sense of urgency: drive to resolution, stress management)
"Ability to work within an international team environment
"Computer Proficiency (MS Office).
Languages:
Good verbal and written communication skills (English)
Hours per week:
40 hours / day
5 days / week
Duration of the assignment:
6 months
Start date: 7th December