The Clinical Trial Supply Assistant (CTSA) supports the Clinical Trial Supply Manager (CTSM) in the fulfilment of his/her responsibilities.
The CTSM is accountable for the set-up and follow-up of the logistical activities from issue of a draft concept protocol till the overall vaccine reconciliation at study end.
- For several studies, give support to the CTSMs to ensure a proper study conduct and follow-up (audit, inspection, process improvement, etc.).
- Responsible to encode and maintain the protocol logistical requirements in the logistic demand system (SAP ESR) based on the output of the logistical and randomization kick-off meeting.
- Manage the documentation, authorizations, country requirements, systems linked to distribution activities (depots & clinical sites).
- Retrieve and analyse data for stock management.
- Perform overall reconciliation of vaccines at study end and ensure proper documentation is available.
- Ensure relevant documentation is archived and posted in the electronic Trial Master File (eTMF) at different milestones and maintain the Expected Document List updated.
- Act as Subject Matter Expert for one or several processes of the team. Ensure standard processed and ways of working are in place across all projects and studies for all key activities of the CTSAs.
- Develop and maintain the appropriate documentation (guidance and training material to support operations) related to logistic processes.
- Bachelor’s degree or equivalent and minimum 2 years of experience in industry (including pharma experience).
- Proficient in MS Office (Excel), SAP is a plus.
- Good Manufacturing Practices' (GMP) knowledge.
- A scientific background is a plus.
- Good organization skills.
- Stress resistant.
- Flexible, adaptive.
- Respect of deadlines and milestones.
- Good communication.
- Critical thinking.
- Proficiency in English (oral and written communication).
Area of Specialization:
- Good understanding of the clinical environment and ideally of the logistical aspects of vaccine supplies.
- Life science, Supply chain management.
What we offer
Join a fast-growing team in Belgium and be a key-person in the fulfilment of clinical studies! You will have the chance to work closely to different departments within the Clinical Supply process and to be the best eye we need to make sure that everything goes administratively smooth for the supply of clinical studies.
At Keyrus, thanks to the expertise of our people and external partners, each employee is welcomed with a varied integration program. You will join a dynamic and international environment with enthusiastic and professional colleagues.
We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…) based on your background and experience.
Who we are
Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.