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Drug Supply Coordinator
Eingestellt von Harvey Nash IT Recruitment Belgium
Gesuchte Skills: Sap, Engineer
Projektbeschreibung
Vaccine Supply Coordinator
Role Summary
The Vaccine Drug Supply Coordinator defines and implements the optimized strategy of Clinical Trial Supplies for all prophylactics and epidemiologic studies (Ph I-IV, multicountry), from start to end, in compliance with ICH GCP/GMP guidelines and internal policies/SOPs/guidance.
You will be the key point of contact between the Clinical Study Delivery Leaders and the packaging facilities (CTSU),
Key Responsbilities
- Coordinates Study Supply needs (Vaccines, study material, Biospecimen labels) based on the concept protocol
- Reviews the study documents with regard to vaccine/drug related sections
- Initiates and drives the Randomization strategy kick-off meeting and the Vaccine Requirement meeting
- Creates packaging and labelling requirements. Enters, approves and follows up the supply request in SAP (ESR) system
- Approves Label Master Sheet for central Clinical Operations
- Coordinates supplies distribution strategy and ensure proper stock management at site level
- Coordinates the return and destruction of supplies
- Prepares the IVRS (SBIR) loading request, review/validates SBIR application and develops SBIR study specific user guide.
- Gives training to Local Study Contacts on cold chain and logistics whenever necessary
- Manages all study related information related to logistics in the trial master file .
Prerequisites
Education: University Scientific Degree,
Master: Pharmacy, Chemistry, Bio Engineer, Biology, Bio Medical Sciences
Knowledge/skills:
- 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.
Soft skills:
Strong leadership
Strong project management skills
Ability to Interact within different levels of the organization
Ability to work effectively in a remote environment.
Interactions outside of company, with external providers, vendors and drug depot
Experience:
drug supply (including IVRS) management and GMP experience are preferred. Ideally 5 years of experience in clinical trials environment
Role Summary
The Vaccine Drug Supply Coordinator defines and implements the optimized strategy of Clinical Trial Supplies for all prophylactics and epidemiologic studies (Ph I-IV, multicountry), from start to end, in compliance with ICH GCP/GMP guidelines and internal policies/SOPs/guidance.
You will be the key point of contact between the Clinical Study Delivery Leaders and the packaging facilities (CTSU),
Key Responsbilities
- Coordinates Study Supply needs (Vaccines, study material, Biospecimen labels) based on the concept protocol
- Reviews the study documents with regard to vaccine/drug related sections
- Initiates and drives the Randomization strategy kick-off meeting and the Vaccine Requirement meeting
- Creates packaging and labelling requirements. Enters, approves and follows up the supply request in SAP (ESR) system
- Approves Label Master Sheet for central Clinical Operations
- Coordinates supplies distribution strategy and ensure proper stock management at site level
- Coordinates the return and destruction of supplies
- Prepares the IVRS (SBIR) loading request, review/validates SBIR application and develops SBIR study specific user guide.
- Gives training to Local Study Contacts on cold chain and logistics whenever necessary
- Manages all study related information related to logistics in the trial master file .
Prerequisites
Education: University Scientific Degree,
Master: Pharmacy, Chemistry, Bio Engineer, Biology, Bio Medical Sciences
Knowledge/skills:
- 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.
Soft skills:
Strong leadership
Strong project management skills
Ability to Interact within different levels of the organization
Ability to work effectively in a remote environment.
Interactions outside of company, with external providers, vendors and drug depot
Experience:
drug supply (including IVRS) management and GMP experience are preferred. Ideally 5 years of experience in clinical trials environment
Projektdetails
Geforderte Qualifikationen
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Kategorie:
SAP Entwicklung, Ingenieurwesen/Technik