Job Description

As a Clinical Trial Supply Assistant within Keyrus Biopharma, you will join a team on client's site to support the Clinical Trial Supply department's activities and resonsibilities.

Role and main tasks:

For a project or a group of studies covering different projects, give support to the Clinical Trial Supply Manager to ensure a proper study conduct and follow-up (audit, inspection, process improvement, …)
Responsible to encode and maintain the protocol logistical requirements in the logistic demand system based on the output of the logistical and randomization kick off meeting.
Manage task and purchase orders linked to logistical activities (depot & distribution activities), give support to the Clinical Trial Supply Manager on managing logistical study budget.
Retrieve, analyze data for stock management and propose resupply strategy
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) according to the Reference Model.
For each study, define the operational set-up in order to align flows, operational strategies and activities (label creation, label/pack warehouse & distribution), ensure alignment with the other stakeholder’s constraints and develops study logistical plan and including detailed schedule and budget.
Act as Subject Matter Expert for one or several processes of the team. Ensure standard processes and ways of working are in place across all project and studies for all key activities of CTSAs.
Develop and maintain the appropriate documentation (SOPs, WIKI, guidance, and training material to support operations) related to logistic processes.

Profile

Education:

Bachelor degree

Required Experience & Knowledge :

1 to 3 years of experience in clinical study environment
Background knowledge of clinical trials is an asset
Has a good understanding of the clinical research and clinical trial conduct, ideally in supplies management.
Experience working in teams with a broad range of cultures.
Good Clinical Study knowledge
Knowledge of GCP/GMP/quality standards
Knowledge of Clinical Trial Supplies Operations (Labelling/Pack/WH/Distribution) is an asset
Good communication skills.
Experience working in teams with a broad range of cultures.
Process minded, keeping openness for specific project needs.
Ability to coach colleagues and to engage them in new ways of working.
Able to manage priorities, performance targets and project initiatives in a global environment.
Acts as role model in line with the company's core values and expectations.
Effective at problem solving and conflict resolution.
Possesses good English language written and verbal communication skills. Knowledge of French is an asset.

What we offer

You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…). Each employee will be welcomed with a varied integration program. We invest considerable time and resources in training our staff (technical and non-technical courses). You will join a dynamic and international environment with enthusiastic and professional colleagues.

Who we are

Keyrus Biopharma 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 Biopharma 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.

Keyrus Belgium Offices:

161 Drève Richelle bâtiment L
Rue Emile Francqui, 1 - Mont-Saint-Guibert

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