Clinical Product Management Specialist - Onsite

Clinical Product Management Specialist - Onsite

Location: Franklin Lakes, NJ

Duration: 7 Months

Total Hours/week: 40

Shift: 1st Shift

Client: Medical Devices Company

Job Category: Clinical

Level of

Experience:

Senior Level

Employment Type: Contract on W2 (US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)

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

• 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.
• Research products/potential vendors, procure study supplies, monitor 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 storage of Study Product and Study Supplies under secure, controlled conditions compliant with GCP and other applicable regulations and guidelines, and adhere to required limits of temperature and humidity.
• Complete 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).
• Track documentation and file in eTMF.
• Responsible for Transparency Reporting for designated studies.

• Minimum BA/BS in Science, Engineering, Pharmacy, or other Allied Health professions.
• Minimum of 3 years experience in medical device clinical trials, pharmaceutical, biotechnology or related firms, 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, Excel (formulas), Databases (frontend data entry).
• Strong English written and verbal communication skills.
• Knowledge of clinical supply planning, packaging, and labeling.
• Clinical study product handling experience is preferred.
• Experience in inventory management and kit assembly.
• Highly organized, detail oriented, focused and creative.
• Excellent interpersonal skills and communication.
• Ability to perform under a highly matrix environment and thrive in a multidisciplinary team environment.
• Computer savvy, detailed oriented, fast learner, and agile.
• Database experience is a MUST.

• 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.

Onsite Position. Office and laboratory/storage environment.