Trial Product Handling Lead

Trial Product Handling Lead

Location: Plainsboro, New Jersey

Type: Contract

The Trial Product Handling Specialist 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.

Act as the primary support for NACD to ensure quality, patient safety, temperature data integrity, and compliance with regulatory requirements during receipt, storage, and handling of investigational products across the trial lifecycle.

Proactively identify risks and process improvements, developing plans in collaboration with stakeholders to address issues.

Contribute to assigned therapeutic areas and lead or initiate meetings for problem resolution.

Assist sites and CRAs with trial product handling issues, ensuring proper escalation to management as needed.

Manage start-up and close-out activities for trial product handling, including training sites on TMD and HOT management, approving calibration certificates, and qualifying sites for investigational product receipt.

Review and act on HOT system notifications to ensure timely trial product handling.

Serve as a Temperature Monitoring Device (TMD) expert, supporting sites and CRAs with device-related queries.

Facilitate and lead the trial product release process, ensuring delivery of trial product at sites in a timely manner.

Review and process HOT and non-HOT deviation events across NACD.

Provide SOP and GxP input as a subject matter expert for trial product handling.

Support FDA inspections and internal audits related to trial product management.

Serve as a key operational contact, coordinating trial product issues, escalations, and resolutions.

Maintain records of investigational product destruction documentation during the trial.

Monitor inventory and discrepancies to ensure ongoing trial product destruction and compliance.

Collaborate with global and internal stakeholders to support trial-related initiatives.

Manage depots, oversee communication, and resolve issues through meetings and planning.

Identify, analyze, and address process gaps, implementing continuous improvement strategies.

Support training development and serve as a lead in process improvement efforts.

Bachelor's degree in a science-related discipline preferred; relevant experience may substitute.

Minimum of 5 years of clinical trial experience, especially in pharmaceutical, biotechnology, CRO, or healthcare settings.

Proven experience in clinical supply chain management, including handling of temperature monitoring devices and trial product supplies.

Demonstrated leadership and facilitation skills in collaborative environments.

Experience working with global stakeholders and vendor management.

Knowledge of clinical trial systems such as IRT solutions and inventory management tools.

Proficiency in MS Office (Word, PowerPoint, Project).

Ability to multitask, prioritize, and make decisions under pressure.

Strong communication skills in English, both verbal and written.

Understanding of GCP regulations related to trial management.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Ref: #568-Clinical