MillenniumSoft Inc · 1 month ago
Clinical Product Management Specialist - Onsite
Franklin Lakes, NJ
Contract
Onsite
Mid, Senior Level
3+ years expMillenniumSoft Inc is seeking a Clinical Product Management Specialist to support their Medical Devices client. The role involves product procurement, inventory management, and collaboration with Clinical Project Managers to ensure compliance with quality management systems and regulatory requirements.
Staffing & Recruiting
No H1B
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
Qualification
Required
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
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
Preferred
Clinical Study product handling experience is preferred
Company
MillenniumSoft Inc
Hire us to hire for you Staffing is not a straightforward activity.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Sailaja Mashetty
Partner - Customer Sucess
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