Job Description
In this role, you will undertake activities to assess, plan and set up trial supply schemes for assigned projects and manage vendors involved in clinical supplies and interactive response technology.
This is a temporary position to cover a maternity leave period.
You will:
1. Analyse clinical trial protocols and translate requirements to establish an efficient supply chain solution for PSI studies
2. Build and maintain a drug demand forecast in line with planned enrolments
3. Plan the optimal campaign strategy, to ensure clinical supplies are available in accordance with the project requirements
4. Manage the CMO vendor - oversee packaging, labelling, procurement, distribution and QP release activities to ensure supplies are delivered on time
5. Manage the IRT vendor - lead study specific system set-up, UAT, system acceptance and ongoing system updates
6. Develop clinical supply plans and provide input for the development of vendor management plans
7. Participate in the selection of trial supply vendors and IRT vendors for PSI studies
8. Support and train PSI teams in clinical supply management
9. Liaise with PSI project teams, company divisions, clients and vendors
10. Assess risks associated with clinical product management and quality incidences reported by vendors
11. Support business development tasks related to clinical trial supply services
Qualifications
12. College or University degree
13. 3-5 years experience in Clinical Supply Chain Management (Essential)
14. Experience working with supply chain technologies (i.e. IRT, CTMS, IWRS integration rules and principles)
15. Training in GMP and GDP
16. Ability to communicate effectively with vendors and internal parties
17. Ability to work both independently and in a team environment
18. PC skills to be able to work with MS Word, Excel and PowerPoint
Additional Information