Clinical Product Management Specialist
Insight Global
Job Description
The Clinical Product Management Specialist is responsible to provide product procurement, handling, inventory management, and shipment services to their assigned studies. They will work closely with the Clinical Project Manager and Medical Affairs to fulfill their study product related deliverables in conjunction with the Quality Management system SOPS and regulatory requirements.
-Develop clear and efficient study product secondary labeling and packaging designs to facilitate study execution, protocol compliance, and product accountability.
-Responsible for researching products/potential vendors, researching/procuring study supplies, monitoring inbound shipments and cost accruals per study.
-Maintain Study Product and Study Supply inventory using Inventory management database.
-Inspect Study Product, including packaging and labeling per SOP and Study-specific requirements.
-Accountable for assembly of kits, formatting and printing labels, over-labelling.
-Oversee the storage of Study Product and Study Supplies under secure, controlled conditions which are compliant with GCP and other applicable regulations and guidelines, and which adhere to the required limits of temperature and humidity.
-Complete the disposition of product and/or supplies returned at the end of each study, including destruction or restocking.
-Responsible for packaging, shipping documentation and shipping of material (International, Domestic)
-Tracking Documentation and filing in eTMF.
-Responsible for Transparency Reporting for designated studies.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Skills and Requirements
3+ years’ experience in Medical Device clinical trials
Experience in the process of clinical study supply (IUO and Ancillary) management and execution.
Clinical Study product handling experience
Knowledge of clinical supply planning, packaging, and labeling
Experience assembling kits, formatting and printing labels, over-labelling
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