Title: Clinical Product Management Specialist
Location: Franklin Lakes, NJ 07417 (Onsite)
Duration: 12 Months
 
Description:
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. The Clinical Product Management Specialist is responsible to provide product procurement, handling, inventory management, and shipment services to their assigned projects/Business Units studies. 
 
Job Responsibilities: (Primary Duties, Roles, and/or Authorities)

• 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.

 
Education and Experience:

• 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 and Skills:

• 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.
• Clinical Study product handling experience is preferred.
• 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.

 
Physical Demands: (if applicable)

• Must be capable of lifting/moving up to 30lbs.
• Repetitive motions with fingers/hands/wrists required for labeling and kitting products.
• Must be able to sit for long periods of time.

 
Work Environment: (if applicable)

• Onsite Position.
• Office and laboratory/storage environment.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 37.50/hr.