Clinical Product Management Specialist - Onsite

millenniumsoft•Franklin Lakes, NJ

17d•Onsite

About The Position

The Clinical Product Management Specialist is responsible to provide product procurement, handling, inventory management, and shipment services to their assigned projects/Business Units studies. They will work closely with the Clinical Project Manager and Medical Affairs to fulfill their study product related deliverables in conjunction with the client Quality Management system SOPS and regulatory requirements.

Requirements

A minimum BA/BS in Science, Engineering, Pharmacy, or other Allied Health professions.
A minimum of 3 years’ experience in Medical Device clinical trials, pharmaceutical, biotechnology or related firm, including direct exposure to the process of clinical study supply (IUO and Ancillary) management and execution.
Knowledge of Good Clinical Practice (GCP), regulations and guidance relative to the conduct of clinical trials
Proficient in MS Word Processing (Mail Merge experience a plus), Spreadsheets (Must be able to use formulas in Excel) and Databases (front end data entry).
Strong English language written and verbal communication skills.
Knowledge of clinical supply planning, packaging, and labeling.
Demonstrate experience in working on inventory management, and assembly of kits.
Highly organized, detail oriented, focused and creative.
Excellent interpersonal skills and communication skills.
Ability to perform under highly matrix environment, and able to thrive in a multidisciplinary team environment.
Must be computer savvy, detailed oriented, fast learner, and agile.
Database experience is a MUST.

Nice To Haves

Clinical Study product handling experience is preferred.

Responsibilities

Collaborate with the Clinical Study team to include Medical Affairs, Clinical Product Management and other departments as required.
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.