Drug Supply Assistant

One of our clients, a multinational pharmaceutical company, currently requires a Drug Supply Assistant.

Location: South of Brussels

Start date: ASAP

Duration: 18 months

MISSION DESCRIPTION:

The Drug Supply Assistant (DSA) works in collaboration with the Drug Supply Coordinator and Manager (DSC, DSM) by providing administrative and operational support for all activities related to the logistic of clinical trial supplies.
The DSA reports to the DSM.
A DSA can support one or several DSCs/DSMs, on one or several studies.

KEY RESPONSIBILITIES:

Working on all types of studies according to ICH GCP and/or other ethical guidelines,
and SOPs within defined timelines to ensure the quality of the study data with regard to clinical trial supplies.
Have basic knowledge on status of individual studies on which she/he is working.

A. Operational support

- Create, approve & follow up the supply request in the ordering system (SAP ESR System):
- Supply Request for clinical trial supplies
- Supply Request for material and biospecimen labels
- Any other work related to the study logistics delegated by the DSC
- Design the study protocol into packaging and labelling requirements into SAP ESR System
- Tracking of expiry dates of clinical trial supplies and material
- Initiate Shipping Orders to Warehouses
- Obtain all necessary documents for shipments (Proforma Invoice, Import License)
- Evaluate the stocks in Warehouses, Transit Centres, and Investigator sites.
- Perform the Reconciliation/Destruction of expired treatments at Warehouses
- Whenever needed, coordinate with study management team for the return and destruction of supplies.
- Update relevant tracking files with correct and accurate information (supply request numbers, Treatment numbers, Expiry dates, shipment dates)

B. Document Management and Administrative Support

- Preparation & support for the operational meetings (eg Rando strategy kick-off meeting, vaccines requirements meeting with CTSU)
- Follow-up request of SBIR users access and link the Investigational sites with Warehouses
- Assist in design/customisation of the Study Procedures Manual and specific SBIR user guide
- Track day to day, in a proactive and autonomous manner, essential documents related to Section 7 (for SBIR only) and 8.
- Draft File Notes as per DSC/DSS guidance.
- Review and follow up on an ongoing basis the content of section 7 (SBIR only) and 8 of Study file..
- Create tracking tables for studies and clinical trial supplies. Maintaining accurate and up-to-date information of the project eg expiry dates, lot status, shipment dates .
- Verify monthly invoices from Warehouses

C. Process Activities

- Represent DSA function in taskforce meeting.
- Provide support in trainings (creation of material for training/refresher session ).
- Actively participate to logistical meetings with internal and external partners (CTSU, DM, external depot,).

PREREQUISITES

- Good communication skills
- Team spirit
- Well organized, eye for detail
- Independent worker
- Stress resistant
- Motivated and dynamic personality
- Proactive
- IT tools oriented. Familiar with Microsoft Word, Excel, PowerPoint, .. and other computer systems
- Good knowledge of English (both oral and written) is essential
- Background knowledge of clinical trials is an asset