Responsible for managing drug supply planning, inventory control, and distribution activities including label/pack scheduling, issue resolution, change implementation, vendor oversight, and scope review related to clinical supplies on multiple clinical programs.
In addition, working closely with CClient, Regulatory Affairs, Quality Assurance, Clinical Operations, and /or SMPA external partners and CMOs, as needed, building strong working relationships, support study project teams and ensure timely Investigational Product (IP) for clinical trials.
Skills:
Lead and manage end-to-end Clinical Supply Chain activities (planning, packaging and labeling, distribution, returns and destruction) for assigned clinical programs in early and late phases.
Develop and manage supply forecasts, supply plans, and timelines in collaboration with Clinical and CClient.
Manage IP inventory levels at the depots and clinical sites; coordinate the inventory from manufacturer to depot or clinical sites.
Design and/or review label text to meet product requirements and ensure compliance with US and international regulations.
Ensures effective management of IP based on study timing and in accordance with clinical protocols, cGMP, GCP, ICH, FDA, and other applicable international, federal, and/or local regulations.
Collaborate closely with Clinical Operations, CClient, Regulatory Affairs, QA, and PDM to ensure advancement of clinical programs; ensure supplies readiness.
Manage clinical supply and logistics and resolve issues such as shipment delays, temperature excursions, import/export; work closely internal Trade Compliance & Logistics team.
Demonstrates a solid understanding of clinical study design (randomized, blinded, open label etc.) and execution.
Manage assign clinical trial contracts, purchase orders including invoices and budget for clinical supply vendor; participate in CSC budget and forecast planning.
Represent Clinical Supply Chain function at clinical trial meetings; communicate plan and timelines to internal and external customers and partners.
Education:
BS/BA degree (Masters preferred) in life sciences or business major or equivalent required.
Minimum 5-7 years in life sciences industry related experience, including Project Management, Pharmaceutical Development, Clinical Supply Management, and/or Clinical Trials Coordination.
At least 3+ years in Clinical Supplies Management.
Proficient knowledge of Microsoft Excel, PowerPoint, and Project software required.
APICS certification (CPIM, CLTD, CSCP) preferred.
Numbers & Facts
Location
Marlborough, MA
Industry
Other/Not Classified
Salary
$100–$103 Per Hour
Company Size
100 to 499 employees
Year Founded
1998
Website
www.eteaminc.com
About Company
Looking for a great job? Join eTeam. We’re looking for talented staffing professionals to join our staff. We also provide contract assignments and full-time jobs at Fortune 2000 Companies. We’ve been named one of the best companies to work for by Staffing Industry Analysts and New Jersey Business.
Skills
APICS Certificationunmatched
Billingunmatched
Biologyunmatched
Budget Managementunmatched
Budgetingunmatched
CMOSunmatched
Certified Supply Chain Professional (CSCP)unmatched
Certified in Production and Inventory Management (CPIM)unmatched
Clinical Practices/Protocolsunmatched
Clinical Trialunmatched
Clinical Trial Managementunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Distribution Controlunmatched
Drug Developmentunmatched
FDA (Food and Drug Administration)unmatched
Forecastingunmatched
GCP (Good Clinical Practices)unmatched
Healthcare Qualityunmatched
ICH Regulationsunmatched
IP (Internet Protocol)unmatched
Import/Exportunmatched
Intellectual Property (IP)unmatched
Inventory Levelsunmatched
Inventory Managementunmatched
Inventory Planningunmatched
Investigational New Drug (IND)unmatched
Logisticsunmatched
Maintain Complianceunmatched
Medical Productsunmatched
Microsoft Excelunmatched
Microsoft PowerPointunmatched
Problem Solving Skillsunmatched
Product Data Management (PDM)unmatched
Project/Program Managementunmatched
Purchase Ordersunmatched
Quality Assuranceunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Supply Chainunmatched
Supply Chain Managementunmatched
Time Managementunmatched
Vendor/Supplier Managementunmatched
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