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Drug Supply Coordinator
Eingestellt von Harvey Nash IT Recruitment Belgium
Gesuchte Skills: Design, Client
Projektbeschreibung
One of our client, a multinational pharmaceutical company, currently requires a Drug supply Coordinator
Location: South of Brussels
Start date: ASAP
Duration: 18 months
MISSION DESCRIPTION
The Drug Supply Coordinator is the key point of contact between the Study Delivery Managers/Leaders and the Clinical Trial Supply Unit (CTSU)/Clinical Supply Planning (CSP).
He/she defines and implements the optimized strategy of packaging and shipment of Clinical Trial Supplies for all Immunotherapeutics studies (Ph I-III, multi-country) from start to end, in compliance with ICH GCP/GMP guidelines and policies/SOPs/guidances.
RESPONSIBILITIES
* Manage clinical trial supplies for all types of studies (Phase I to Phase III, collaborative, multi-country) to ensure the delivery of adequate clinical supplies within defined timelines.
* Coordinate & consolidate all Clinical trial supplies related information in conjunction with CTSU, Project Management and Clinical Team, to ensure adequate and sufficient forecasting of drug product, comparators and forecasting of packaging workload (ie supply strategy, supply planning, labelling).
* Organize and consolidate Logistical and Randomization kick off meeting with all stakeholders in due time.
* Collaborate closely with Clinical Demand Coordinator from CSP in regards to shipments dates, lots allocation, labelling timelines, clinical study feasibility analysis, and IMP forecasting.
* Review of the clinical trial protocols with regards to regulatory and GMP requirements, Clinical Trial Supply aspects and randomization system. Analyse the feasibility and assess the risks of the proposed study design in regards to clinical trial supplies (double blind lots ) & randomization system.
* Create Study Pharmacy manual (Study Procedure Manual), ensuring that the document is available on time.
* Design the finished IMP through translation of the study protocol into packaging and labelling requirements, ensuring a proper balance between the feasibility of the technical aspects & an optimal designed clinical presentation, as well as compliance with local regulations.
* In collaboration with the Drug Supply Assistant, create, approve & follow up the supply request in the Clinical Trial Supply system (ie ESR).
* Review and approve Label Master Sheet at central Clin Ops level. Collaborate with the Local Study Contact for review and approval of Label Master Sheet, at local level, in due time.
* Ensure adequate & sufficient supply of IMP and material (if applicable) at central/local depots according to the needs investigational sites at any time during trial duration.
* Coordinate an optimal IMP distribution strategy to ensure timely delivery to clinical sites.
* Coordinate the setup and management of contracted service provider as central drug depot (and local drug depot if applicable).
* Whenever needed, coordinate with study management team for the return and destruction of supplies. * Prepare the SBIR loading request with the statistician and GSM/GSLs, review/validate the application and develop study specific userguide.
* Define the trigger levels for the depots/sites with the randomization system (to be able to monitor the IMP inventory and expiry dates).
* Participate in Investigators/Monitors meeting for the studies they have been assigned to, present all logistical aspects of a study (including cold chain management), and organize workshop sessions as appropriate.
* Giving training to LOC and central depot on cold chain and logistics whenever deemed necessary by the Study Management team.
* Have detailed knowledge and view of his/her studies in order to be the reference person for all drug supply related issues and cold chain issues (ie temperature excursion) within the Clinical Project Team. Provide feedback and follow-up on issues as appropriate.
* Be able to anticipate, identify, analyse, propose solutions, and make basic routine decision. Seek guidance as appropriate.
* Take part in process/tools development/improvement initiatives related to drug supply. Promote sharing of Best Practices.
* Delegate work to Drug Supply Assistant & coach him/her.
* Assure the filing of all drug supply related information and documents.
PREREQUISITES
Education
Master (university) degree in Sciences or equivalent background.
Knowledge
Good knowledge and understanding of Drug Supply Management roles and activities
Good knowledge ICH-GCP
Knowledge of GMP is an asset
Excellent knowledge of written & spoken English - knowledge of French is an asset.
Familiar with electronic tools like Microsoft Word, Excel, PowerPoint, and Project
Experience
At least 2 years' experience in clinical trials supplies environment
IVRS and Drug Supply Management experience is an asset.
Location: South of Brussels
Start date: ASAP
Duration: 18 months
MISSION DESCRIPTION
The Drug Supply Coordinator is the key point of contact between the Study Delivery Managers/Leaders and the Clinical Trial Supply Unit (CTSU)/Clinical Supply Planning (CSP).
He/she defines and implements the optimized strategy of packaging and shipment of Clinical Trial Supplies for all Immunotherapeutics studies (Ph I-III, multi-country) from start to end, in compliance with ICH GCP/GMP guidelines and policies/SOPs/guidances.
RESPONSIBILITIES
* Manage clinical trial supplies for all types of studies (Phase I to Phase III, collaborative, multi-country) to ensure the delivery of adequate clinical supplies within defined timelines.
* Coordinate & consolidate all Clinical trial supplies related information in conjunction with CTSU, Project Management and Clinical Team, to ensure adequate and sufficient forecasting of drug product, comparators and forecasting of packaging workload (ie supply strategy, supply planning, labelling).
* Organize and consolidate Logistical and Randomization kick off meeting with all stakeholders in due time.
* Collaborate closely with Clinical Demand Coordinator from CSP in regards to shipments dates, lots allocation, labelling timelines, clinical study feasibility analysis, and IMP forecasting.
* Review of the clinical trial protocols with regards to regulatory and GMP requirements, Clinical Trial Supply aspects and randomization system. Analyse the feasibility and assess the risks of the proposed study design in regards to clinical trial supplies (double blind lots ) & randomization system.
* Create Study Pharmacy manual (Study Procedure Manual), ensuring that the document is available on time.
* Design the finished IMP through translation of the study protocol into packaging and labelling requirements, ensuring a proper balance between the feasibility of the technical aspects & an optimal designed clinical presentation, as well as compliance with local regulations.
* In collaboration with the Drug Supply Assistant, create, approve & follow up the supply request in the Clinical Trial Supply system (ie ESR).
* Review and approve Label Master Sheet at central Clin Ops level. Collaborate with the Local Study Contact for review and approval of Label Master Sheet, at local level, in due time.
* Ensure adequate & sufficient supply of IMP and material (if applicable) at central/local depots according to the needs investigational sites at any time during trial duration.
* Coordinate an optimal IMP distribution strategy to ensure timely delivery to clinical sites.
* Coordinate the setup and management of contracted service provider as central drug depot (and local drug depot if applicable).
* Whenever needed, coordinate with study management team for the return and destruction of supplies. * Prepare the SBIR loading request with the statistician and GSM/GSLs, review/validate the application and develop study specific userguide.
* Define the trigger levels for the depots/sites with the randomization system (to be able to monitor the IMP inventory and expiry dates).
* Participate in Investigators/Monitors meeting for the studies they have been assigned to, present all logistical aspects of a study (including cold chain management), and organize workshop sessions as appropriate.
* Giving training to LOC and central depot on cold chain and logistics whenever deemed necessary by the Study Management team.
* Have detailed knowledge and view of his/her studies in order to be the reference person for all drug supply related issues and cold chain issues (ie temperature excursion) within the Clinical Project Team. Provide feedback and follow-up on issues as appropriate.
* Be able to anticipate, identify, analyse, propose solutions, and make basic routine decision. Seek guidance as appropriate.
* Take part in process/tools development/improvement initiatives related to drug supply. Promote sharing of Best Practices.
* Delegate work to Drug Supply Assistant & coach him/her.
* Assure the filing of all drug supply related information and documents.
PREREQUISITES
Education
Master (university) degree in Sciences or equivalent background.
Knowledge
Good knowledge and understanding of Drug Supply Management roles and activities
Good knowledge ICH-GCP
Knowledge of GMP is an asset
Excellent knowledge of written & spoken English - knowledge of French is an asset.
Familiar with electronic tools like Microsoft Word, Excel, PowerPoint, and Project
Experience
At least 2 years' experience in clinical trials supplies environment
IVRS and Drug Supply Management experience is an asset.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Medien/Design