Clinical Trial Supply Manager

il y a 2 semaines

Ghent, Belgique HR One Group Temps plein

About the Company

The company is a late-stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics. The unique SIMPLE AntibodyTM platform and suite of Fc engineering technologies combined with the complementary expertise of our people enabled us to build a clinical-stage portfolio of novel product candidates – tailored from discovery through development to address patient needs.

About the Role

To further strengthen the Clinical Trial Supply (CTS) team we are looking for a talented Clinical Trial Supply Manager (CTSM). The CTSM represents product supply in the Clinical Study Teams and drives the development and execution of effective product supply strategies in close collaboration with various key stakeholders. This role provides an opportunity to design and implement effective processes within a fast‐growing organization.

Responsibilities

Drives the processes necessary for IRT set-up, conduct and close-out from a clinical trial supplies perspective; Develops and executes detailed clinical trial supply project plans in close collaboration with stakeholders; Drives the development of a study specific pharmacy manual and other relevant guides in close collaboration with Clinical Study Team and CMC team; Actively track drug inventory and visualizes active drug consumption versus projected forecast; Contributes to planning and organization of global product manufacturing activities; Responsible for collecting, registering and archiving information and documents in accordance with the applicable GxP guidelines for clinical studies (TMF, eTMF); Contributes as needed to CTS process development (label development, IRT, SOPs, ..); Responsible to consolidate, maintain and track the clinical trial budget.

Qualifications

Master's degree in a scientific discipline or equivalent through education and experience; Minimum 4 years' experience in field of clinical trial supplies; Knowledge of GxP regulatory requirements; Quality conscience attitude; Excellent organization and planning skills; Strong communication skills and able to build relationship with internal and external stakeholders – team player with an analytical mindset and delivery-oriented focus; Flexible attitude in combination with a proactive mindset; Can do mentality; Working knowledge with MS Office package; Fluent in English – our working language. Required Skills Master's degree in a scientific discipline or equivalent through education and experience; Minimum 4 years' experience in field of clinical trial supplies; Knowledge of GxP regulatory requirements; Quality conscience attitude; Excellent organization and planning skills; Strong communication skills and able to build relationship with internal and external stakeholders – team player with an analytical mindset and delivery-oriented focus; Flexible attitude in combination with a proactive mindset; Can do mentality; Working knowledge with MS Office package; Fluent in English – our working language. Preferred Skills Experience in a cross-functional environment; Ability to contribute to the continued build out of the supply chain team. Pay range and compensation package A competitive salary package with extensive benefits; Equal Opportunity Statement We are committed to diversity and inclusivity.

  • Clinical Trial Supply Manager

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    About the CompanyThe company is a late-stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics. The unique SIMPLE AntibodyTM platform and suite of Fc engineering technologies combined with the complementary expertise of our people enabled us to build a clinical-stage portfolio of novel product...

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