- Manage Clinical trial supplies for all types of studies (Phase I to Phase III, IV, collaborative, multi country) to ensure the delivery of adequate clinical trial supplies within defined timelines and that for Immunotherapeutic studies and local studies were vaccines are required.
- Coordinate and consolidate the Study Supply needs in conjunction with CSP-CTSU and Clinical Team, to ensure adequate and sufficient forecasting of vaccines and drug product, comparators and forecasting of packaging workload (i.e. supply strategy, supply planning). Collaborate closely with CSP-CTSU in regards to shipments dates, lots allocation, labeling timelines, clinical study feasibility analysis, and IMP forecasting for a specific study.
- Review the clinical trial protocols and study procedure manual with regard to regulatory and GMP requirements, CMC (Chemistry, Manufacturing and Controls) issues and Clinical Trial Supply aspects. Analyze and evaluate the feasibility and consequences of design proposed in regards to clinical trial supplies (double blind lots, dose escalation &) and randomization system (). Develop study procedures manual (pharmacy manual) if needed, ensure document is available on time.
- Design finished IMP through translation of the protocol into packaging and labelling requirements, ensuring a proper balance between the feasibility of the technical aspects, and an optimally designed clinical presentation, as well as compliance with local regulations. Create, approve and follow up the supply request in the relevant system (ESR) (or delegate as appropriate to drug supply assistant).
- Assure adequate and sufficient supply of IMP and material (if applicable) at central/local depots and Investigator sites at any time during trial duration.
- Coordinate an optimal clinical trial supplies distribution strategy to ensure timely delivery to investigational sites.
- Whenever needed, coordinates with clinical team the return and destruction of supplies and the follow-up of complaints.
- Define the trigger levels for the depots/sites with the randomization system (to be able to monitor the clinical trial supplies inventory and expiry dates).
- As needed, participates to Investigators/Monitors meeting for the studies they have been assigned to, present all logistical aspects of a study (including cold chain management), organize workshop sessions as appropriate.
- Give training to LOC on cold chain and logistics whenever deemed necessary by the Study Manager
- Initiate and drive the Randomization kick-off meeting and requirements meetings.
- Have detailed knowledge and view of his/her studies in order to be the reference person for all clinical trial supply related issues within the study team / clinical project team (as needed). Provide feedback and surface issues as appropriate.
- Anticipate, identify, analyze and propose solutions, make basic and routine decisions with little or no guidance. Seek guidance as appropriate.
- Take part to process/tools development/improvement initiatives related to the logistical aspects of a clinical trial. Promote sharing of Best Practices.
- Delegate work to Drug Supply Assistant and coach him/her depending on expertise. Supervise his/her work and give feedback.
- Manages all study related information related to logistics for the central study file
Scientific Degree, Graduate / University degree (chemical, biological or pharmaceutical) or engineer with management experience in the GCP/GMP regulated environment and good understanding of the applicable regulatory requirements.
Minimum 3 years of experience in clinical trials environment and Minimum 1 year of experience in logistics/drug supply or GMP
- Good knowledge and understanding of vaccines and drug supply management roles and associated activities
- Good knowledge ICH-GCP and regulatory requirements
- Good knowledge of GMP
- Excellent knowledge of written & spoken English, Knowledge of French is an asset.
- Knowledge of Regional organization and understanding of Local Operating Countries structure.
- Basic knowledge of project vaccine, CDP, Target Product Profile for her/his project
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