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Clinical Trial Assistant
Eingestellt von Elevate Direct
Projektbeschreibung
CLINICAL TRIAL ASSISTANT - BEERSE, BELGIUM - €24 - €28 PER HOUR - 5 MONTHS
This individual contributor is responsible for the management of clinical supplies during the execution phase of clinical trials consistent with GMP guidelines with a specific focus on Temperature Management & Control of Clinical Supplies.
Description of the Role:
Responsible for management of all temperature excursions associated to clinical supplies during the trial execution ensuring prompt resolution and compliance with all SOP, GMP, Quality, and Regulatory guidelines, contributing to successful subject dosing within Janssen Pharma R&D for all phases of clinical trials
Act as a single point of contact accountable for the business critical need
Manage and adjust supply dispositions via inventory systems including IVR & IWR
Conduct issue resolution activities for the temperature excursion supply aspects of the clinical trials
Develop strong internal collaboration with GCO, DPD, and Quality stakeholders to ensure TOR resolution and overall customer satisfaction
Interface with Global Trial Managers, Trial Supply Managers, Drug Product Development, and Quality to manage trial supply temperature excursions
Responsible for execution of Temperature Monitoring Coordinator role during trial feasibility and throughout trial execution driving robust temperature management within Janssen Pharma R&D for all phases of clinical trials
Review and approval of all Investigational Site Temperature Management Equipment Questionnaire Approvals (TMEQ) for Cold Chain IMP
Act as subject matter experts for temperature management requirements including storage and monitoring capabilities
Customizing protocol specific temperature out-of-range forms based on product attributes
Coordinating quote request and PO setup process to centrally source temperature monitoring devices
Develop strong internal collaboration with GCO stakeholders to ensure customer satisfaction
Supports business process improvement initiatives.
Non Technical Skills and Additional Details
A university/bachelor's degree (or equivalent experience).
Experience with quality system tools preferred (eg Trackwise)
Experience with Interactive Response Technologies for Clinical Trials (eg inventory management functionality)
Experience with the following functions preferred: clinical operations, logistics, quality assurance, clinical supply chain planning, drug product development
Demonstrated knowledge in the following areas:
Clinical Supply Distribution
Clinical Study Execution/GCP
Intermediate to advanced software skills (eg, Microsoft Excel, SharePoint, PowerPoint)
Experience in a highly matrixed environment (preferred) Critical Competencies:
Very strong data analysis and problem solving experience
Highly organized with strong attention to detail
Extreme sense of urgency for the tasks at hand, including ability to drive resolution with minimal management oversight
Excellent written and verbal communication skills
Task oriented (repetitive process)
Strong quality management skills
Strong strategic thinking skills
Excellent problem solving and decision making skills
Strong cross-functional coordination skills
Additional information about the process
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.
This individual contributor is responsible for the management of clinical supplies during the execution phase of clinical trials consistent with GMP guidelines with a specific focus on Temperature Management & Control of Clinical Supplies.
Description of the Role:
Responsible for management of all temperature excursions associated to clinical supplies during the trial execution ensuring prompt resolution and compliance with all SOP, GMP, Quality, and Regulatory guidelines, contributing to successful subject dosing within Janssen Pharma R&D for all phases of clinical trials
Act as a single point of contact accountable for the business critical need
Manage and adjust supply dispositions via inventory systems including IVR & IWR
Conduct issue resolution activities for the temperature excursion supply aspects of the clinical trials
Develop strong internal collaboration with GCO, DPD, and Quality stakeholders to ensure TOR resolution and overall customer satisfaction
Interface with Global Trial Managers, Trial Supply Managers, Drug Product Development, and Quality to manage trial supply temperature excursions
Responsible for execution of Temperature Monitoring Coordinator role during trial feasibility and throughout trial execution driving robust temperature management within Janssen Pharma R&D for all phases of clinical trials
Review and approval of all Investigational Site Temperature Management Equipment Questionnaire Approvals (TMEQ) for Cold Chain IMP
Act as subject matter experts for temperature management requirements including storage and monitoring capabilities
Customizing protocol specific temperature out-of-range forms based on product attributes
Coordinating quote request and PO setup process to centrally source temperature monitoring devices
Develop strong internal collaboration with GCO stakeholders to ensure customer satisfaction
Supports business process improvement initiatives.
Non Technical Skills and Additional Details
A university/bachelor's degree (or equivalent experience).
Experience with quality system tools preferred (eg Trackwise)
Experience with Interactive Response Technologies for Clinical Trials (eg inventory management functionality)
Experience with the following functions preferred: clinical operations, logistics, quality assurance, clinical supply chain planning, drug product development
Demonstrated knowledge in the following areas:
Clinical Supply Distribution
Clinical Study Execution/GCP
Intermediate to advanced software skills (eg, Microsoft Excel, SharePoint, PowerPoint)
Experience in a highly matrixed environment (preferred) Critical Competencies:
Very strong data analysis and problem solving experience
Highly organized with strong attention to detail
Extreme sense of urgency for the tasks at hand, including ability to drive resolution with minimal management oversight
Excellent written and verbal communication skills
Task oriented (repetitive process)
Strong quality management skills
Strong strategic thinking skills
Excellent problem solving and decision making skills
Strong cross-functional coordination skills
Additional information about the process
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.
Projektdetails
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