Drug Supply Associate - Belgium
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Posted on : 17 March 2017
The DSA reports into the Senior CTSM and executes the implementation of an optimized clinical supply strategy for all internal studies from start to end, in compliance with ICH GCP/GMP guidelines and client policies/SOPs/guidances.
- Primary point of contact towards CTS Vendors for day-to-day management of all activities and liaison between CTS Vendors, clinical CRO and internal project team
- Support (s)CTSM in CTS (and IRT) Vendor selection process, contract and budget maintenance
- Helps with the coordination and consolidation of the Study Supply Plan in conjunction with Clinical Team/CRO/CTS Vendors, to ensure adequate and sufficient forecasting of IMP or comparative for a given clinical trial.
- Review of the clinical trial protocols and analysis/evaluation of the feasibility and consequences of design proposed in regards to clinical trial supplies.
- Design of finished IMP through translation of the protocol into packaging and labeling requirements, ensuring a proper balance between the feasibility of the technical aspects and an optimally designed clinical presentation, as well as compliance with local regulations.
- Participate in regular meetings and teleconferences with internal/external parties to ensure adequate execution of day-to-day CTS activities within agreed timelines
- Contribute to the procurement of high quality IMP-related documents, guidelines and/or instructions for internal and/or external use and critical review of vendor documentation
- Active contribution to the GMP/GCP Quality system related to CTS activities, including creation and maintenance of Sponsor SOPs, and to internal/external audits of the clinical supply chain
Skills, expertise and contribution
Accountability / Exercising Judgment / Impact of Decisions / Consequence of Error:
- Crucial role in enabling clinical trial execution : Assurance of adequate and sufficient supply of IMP and material (if applicable) to departments and investigator sites at any time during trial duration and coordination of an optimal distribution strategy to ensure timely delivery to clinical sites.
- Strong sense of responsibility and accountability for accuracy
- Support in CTS Contract and Budget maintenance
- Multiple vendor management
Knowledge & application:
- Good understanding of Drug Supply Management roles and responsibilities, ICH- GCP, GMP and Randomization Systems
- Contribution to Quality system
- Proactive, Detail oriented, methodical and goal driven attitude
Problem Solving & Innovation :
- Strong communication and organizational skills
- Able to work independently but also in a team environment
- Flexible and proactive towards changing needs of supply chain
Other key capabilities:
- Very good knowledge of English (spoken/written)
- Willingness to travel (inter)nationally
There are 2 levels of Drug Supply Associate based on years of solid & relevant experience, determined by: knowledge built up;
- level of independent working;
- level of accountability; kind of projects worked on, level of supervision needed; …
- University degree (Medical, Pharmaceutical, Biomedical, …)