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Clinical Trial Supply and Operational Logistics Manager

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  • ID: 494660
  • Posted: 1/17/2022
  • Location: Norwood, MA
  • Category: Pro - Professional
  • Job Type: Temporary
  • Duration: 9 - 12 Months

Description

Acara Solutions is looking for a Clinical Trial Supply and Operational Logistics Manager for our Client located in Norwood, MA

  • The Clinical Trial Supply and Operational Logistics Manager is responsible for managing the end-to-end supply chain for assigned clinical studies. 
  • He/she will lead efforts to ensure compliant, on-time supply of investigational product and ancillary materials for subject/specimen testing. 
  • The role includes identification and acquisition of appropriate ancillary materials as defined by Study team, forecasting/tracking demand of investigational product and ancillary supplies, establishing and managing distribution to clinical sites, and ensuring final return and destruction. 
  • He/she will also lead process improvement projects for Clinical's supply chain.
  • This role reports to Director, Clinical Affairs, Point of Care, and has no direct reports.
  • Establishes and oversees the creation and execution of clinical supply strategies and plans for assigned clinical studies in conjunction with Clinical Study Leads. 
  • Develops long-term clinical supply forecasts to support planning processes. 
  • Ensures alignment of these plans across applicable departments, including Supply Chain Management and Procurement.
  • Reviews study protocols and provides clinical supply input to the responsible Clinical Study Leads.
  • Identifies ancillary materials based on protocol requirements.
  • Plans and forecasts product volume requirements for assigned clinical studies based on study protocol assumptions. 
  • Adjusts forecasts, as required, based on study progress and changes to clinical and supply assumptions. 
  • Communicates plan details/timelines to internal and external customers.
  • Manages timely and compliant importation/exportation of investigational product, as needed, while coordinating with internal (e.g., Regulatory Affairs, Procurement) and external partners.
  • Establishes and utilizes system to ensure reliable and efficient investigational product and ancillary material shipments to sites. 
  • Generates and reviews shipment requests for accuracy and completeness prior to issuance. Supports transfers of supplies between sites, as needed.
  • Performs all "hands-on' efforts to receive, inventory, and organize investigational product and ancillary materials. 
  • Tracks expiration dating of investigational product and ancillary material and facilitates resupply, as needed. 
  • Prepares temperature-controlled shipments of investigational product and ancillary materials in conjunction with all necessary documentation to ship to sites. 
  • Tracks shipments to ensure their successful arrival.
  • Working in conjunction with Clinical Study Lead(s) for assigned studies, ensures compliance of clinical study supply-related activities with SOPs and regulations and completion/filing of proper documentation throughout each study's lifecycle.
  • Responds to REES temperature excursion alerts and determines best course of action, up to and including immediate relocation of investigational product to temperature-appropriate location (if current refrigerator/freezer failure reported). 
  • Investigates deviations and temperature excursions and documents accordingly.
  • Manages other duties and activities as defined by Management to enhance management of clinical trial inventory.

Pay and Benefits:

  • The Salary for this position is $ 42.00 per hour (Max Pay rate).
 
Job Requirements

 
Required Skills / Qualifications:
  • Minimum of a Associate's Degree in Health Sciences 
  • Minimum of 3 years' experience in clinical supply management and clinical research in the medical technology
  • Minimum of 1 year experience in Clinical Supply Chain, preferably within the clinical /diagnostic laboratory environment
Preferred Skills / Qualifications:
  • Bachelor's Degree in Health Sciences 
  • Minimum of 2 years' experience in clinical supply management and clinical research in the medical technology
  • Proof of training on Infectious Substances Transport - Category A and B requirements; shipping infectious substances (IATA)
  • The Clinical Trial Supply and Operational Logistics Manager will be an organized self-starter with a collaborative attitude and a willingness to learn. 
  • He/she have the ability to complete project tasks with great attention to detail.
  • Good understanding of GCP and ICH guidelines as related to clinical supply processes/management (required); knowledge of clinical study execution, work with contract research organizations, and related areas (highly desirable)
  • Strong working knowledge of MS Office Suite (e.g., Excel, Word, PowerPoint and TEAMS)
  • Excellent oral and written communication skills, to both internal and external customers
  • Organizational skills with keen attention to detail
  • Multitasks and prioritizes workload within a dynamic, culturally diverse organization; effectively manages time
  • Capacity to work both independently and in a team environment
  • Problem solver/analytical thinker

Additional Information:

  • Upon offer of employment, the individual will be subject to a background check and a drug screen
  • The physical demands described here are representative of those that must be met by the successful candidate to perform essential functions of this job. 
  • Candidate is regularly to sit, stand, walk, speak and hear. 
  • Candidate is frequently to use hands and fingers for data entry and telephone use.
  • Candidate regularly lift and move up to 25 pounds. 
  • Candidate regularly enter and work in walk-in refrigerators (2-8C); 
  • Occasionally enter walk-in freezers (-20C) to place or retrieve investigational product; and occasionally place or retrieve investigational product from ultra-low freezers (-70C). 
  • As part of the shipping process, candidate may work with frozen ice packs and or dry ice, according to associated temperature requirements of shipped materials.

Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct, and Aleron's strategic partner, SDI) are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis. The Aleron companies welcome and encourage applications from diverse candidates, including people with disabilities. Accommodations are available upon request for applicants taking part in all aspects of the selection process.

Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.
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