Trial Product Handling Lead
Apply NowCompany: System One Holdings, LLC
Location: Plainsboro, NJ 08536
Description:
Title: Trial Product Handling Lead
Location: Preference is Hybrid 2-3 days/week in Plainsboro NJ OR Remote
Start Date: April 2025
Summary: The Senior Trial Product Handling Specialist Operational Excellence and Delivery is responsible for ensuring accurate trial product handling from start-up to close-out for investigational sites including but not limited to temperature deviation and device handling. The incumbent is responsible for logistics management with vendors for trial product receipt, shipping, and destruction. The incumbent will provide training and guidance to the Trial Product Handling Specialist.
Responsibilities:
Act as a main source of support to ensure that quality, patient safety, temperature data integrity, and compliance with relevant regulatory requirements at investigational sites are adhered to during receipt, storage and handling of investigational product across the trial lifecycle.
Proactively identifies risks, process improvements and partners with stakeholders to develop plan and execute on the opportunity or mitigation.
Contributes actively to assigned therapeutic area. Trial team and other relevant teams. Initiates/leads meetings, when necessary, toward problem resolution.
Assist sites and key stakeholders with trial product handling related issues; ensuring proper issue escalation to management as appropriate.
Focus on start-up and close-out of trial product handling activities for larger more complex trials. Including but not limited to; training sites on TMD and HOT management, approving calibration certificates, HOT registration, qualifying sites for investigational product receipt to assist with ensuring timely first patient first visit milestone.
Responsible for reviewing and actioning HOT related notifications triggered to sites
Act as a Temperature Monitoring Device (TMD) expert assisting sites/CRAs with various Trial product handling queries.
Proactively facilitate and lead the trial product release process for NNCI and depot to assist with ensuring timely delivery of trial product at the site. Ensure timely review of NNCI QC process and partner with vendor to ensure timely medication arrival call.
Point of contact for HOT and non-HOT deviation events across NACD organization. Trial product handling subject matter expert for SOP and GxP input.
Support during FDA inspections and internal audits.
Responsible for serving as primary contact for day-to-day operational trial product support, coordinating, escalating and helping resolve trial product issues.
Manage and maintain tracking, approval, and collection of investigational product destruction documentation during trial life cycle. Regularly review inventory and discrepancy reports to ensure ongoing destruction.
Work with various stakeholders within therapeutic areas, including but not limited to HQ to support global initiatives related to trial product handling, ancillary and vendor management.
Liaise with HQ Supply Planners to assist trial team in the timely shipment of trial product to sites
Attend Investigator and Monitor meetings for training purposes
Manage depots to resolve and mitigate issues including planning and leading monthly and add/hoc meetings
Identifies trial product handling communication and/or process gaps and initiates solutions. Work with various stakeholders to implement and assist in identifying the root causes of trial product handling process related issues affecting compliance and quality. This includes but not limited to oversight of temperature tracking and monitoring systems (HOT system) and various trial product integration systems.
Demonstrates technical expertise within responsibility areas, staying up-to-date of new practices and building knowledge of emerging trends and advances within area
Reviews and interprets clinical trial protocols in relation to trial product handling requirements
Support the identification of training needs within function and the development of training materials to meet those needs. Partner with NNI Training team to develop and support new hire training for CRA's, Trial Product Handling Specialist training, core competency training and investigational site training
Plays a lead role in process improvement initiatives and introduces creative ideas and solutions.
Requirements:
A Bachelor's degree is required (science-related discipline preferred) Relevant experience may be substituted for degree, when appropriate and dependent on the requirements of the position
A minimum of 5 years of clinical trial experience within a pharmaceutical, biotechnology, CRO and/or healthcare setting required
Clinical trial supply management experience required including experience in handling of clinical supplies (temperature monitoring devices) as related to trial product and/or ancillary supplies handling
Demonstrated ability to lead discussions, facilitate collaboration among groups and deliver presentations to achieve objectives
Demonstrated ability to collaborate with local (sites, vendors, various functional teams) and global stakeholder
Experience working in a technical and system driven environment
Demonstrated understanding of trial product system; IRT solutions and inventory management systems
Demonstrated computer skills (MS Office, MS Project, MS PowerPoint )
Able to multi-task, set effective priorities and implement decisions to achieve immediate as well as long term goals
Works well under pressure, with initiative to take on unfamiliar tasks
Knowledge of GCP as related to clinical trial management
Excellent communications skills (verbal, written, presentation) in English
Ref: #568-Clinical
Location: Preference is Hybrid 2-3 days/week in Plainsboro NJ OR Remote
Start Date: April 2025
Summary: The Senior Trial Product Handling Specialist Operational Excellence and Delivery is responsible for ensuring accurate trial product handling from start-up to close-out for investigational sites including but not limited to temperature deviation and device handling. The incumbent is responsible for logistics management with vendors for trial product receipt, shipping, and destruction. The incumbent will provide training and guidance to the Trial Product Handling Specialist.
Responsibilities:
Act as a main source of support to ensure that quality, patient safety, temperature data integrity, and compliance with relevant regulatory requirements at investigational sites are adhered to during receipt, storage and handling of investigational product across the trial lifecycle.
Proactively identifies risks, process improvements and partners with stakeholders to develop plan and execute on the opportunity or mitigation.
Contributes actively to assigned therapeutic area. Trial team and other relevant teams. Initiates/leads meetings, when necessary, toward problem resolution.
Assist sites and key stakeholders with trial product handling related issues; ensuring proper issue escalation to management as appropriate.
Focus on start-up and close-out of trial product handling activities for larger more complex trials. Including but not limited to; training sites on TMD and HOT management, approving calibration certificates, HOT registration, qualifying sites for investigational product receipt to assist with ensuring timely first patient first visit milestone.
Responsible for reviewing and actioning HOT related notifications triggered to sites
Act as a Temperature Monitoring Device (TMD) expert assisting sites/CRAs with various Trial product handling queries.
Proactively facilitate and lead the trial product release process for NNCI and depot to assist with ensuring timely delivery of trial product at the site. Ensure timely review of NNCI QC process and partner with vendor to ensure timely medication arrival call.
Point of contact for HOT and non-HOT deviation events across NACD organization. Trial product handling subject matter expert for SOP and GxP input.
Support during FDA inspections and internal audits.
Responsible for serving as primary contact for day-to-day operational trial product support, coordinating, escalating and helping resolve trial product issues.
Manage and maintain tracking, approval, and collection of investigational product destruction documentation during trial life cycle. Regularly review inventory and discrepancy reports to ensure ongoing destruction.
Work with various stakeholders within therapeutic areas, including but not limited to HQ to support global initiatives related to trial product handling, ancillary and vendor management.
Liaise with HQ Supply Planners to assist trial team in the timely shipment of trial product to sites
Attend Investigator and Monitor meetings for training purposes
Manage depots to resolve and mitigate issues including planning and leading monthly and add/hoc meetings
Identifies trial product handling communication and/or process gaps and initiates solutions. Work with various stakeholders to implement and assist in identifying the root causes of trial product handling process related issues affecting compliance and quality. This includes but not limited to oversight of temperature tracking and monitoring systems (HOT system) and various trial product integration systems.
Demonstrates technical expertise within responsibility areas, staying up-to-date of new practices and building knowledge of emerging trends and advances within area
Reviews and interprets clinical trial protocols in relation to trial product handling requirements
Support the identification of training needs within function and the development of training materials to meet those needs. Partner with NNI Training team to develop and support new hire training for CRA's, Trial Product Handling Specialist training, core competency training and investigational site training
Plays a lead role in process improvement initiatives and introduces creative ideas and solutions.
Requirements:
A Bachelor's degree is required (science-related discipline preferred) Relevant experience may be substituted for degree, when appropriate and dependent on the requirements of the position
A minimum of 5 years of clinical trial experience within a pharmaceutical, biotechnology, CRO and/or healthcare setting required
Clinical trial supply management experience required including experience in handling of clinical supplies (temperature monitoring devices) as related to trial product and/or ancillary supplies handling
Demonstrated ability to lead discussions, facilitate collaboration among groups and deliver presentations to achieve objectives
Demonstrated ability to collaborate with local (sites, vendors, various functional teams) and global stakeholder
Experience working in a technical and system driven environment
Demonstrated understanding of trial product system; IRT solutions and inventory management systems
Demonstrated computer skills (MS Office, MS Project, MS PowerPoint )
Able to multi-task, set effective priorities and implement decisions to achieve immediate as well as long term goals
Works well under pressure, with initiative to take on unfamiliar tasks
Knowledge of GCP as related to clinical trial management
Excellent communications skills (verbal, written, presentation) in English
Ref: #568-Clinical