Clinical Trial Supply and Contracts Specialist

Lab Pros, Inc.

Contracts

August 15, 2014

Clinical Trial Supply and Contracts Specialist

We are seeking a Clinical Trial Supply and Contracts Specialist to join our client's growing Clinical team.  Reporting the Director of Clinical Operations, this position is responsible for the contracting of CROs, clinical sites, central labs and drug repositories, as well as, monitoring, forecasting and managing clinical study supplies. (i.e, study drug, clinical kits, clinical study samples)

Responsibilities

  • Timely completion of contracts work to allow for the timely startup of critical clinical studies
  • Development of a comprehensive and fair budget while meeting study timelines
  • Effective communication and performance with investigator contracting and management of CROs to ensure adherence to timelines and budgets and reductions in re-work
  • Broad interaction with study management teams, Clinical Trial Managers, Legal, Finance, functional leads, external service providers and investigator site staff
  • Preparation of a supply plan to support the demand forecast, including determination of supply overage amounts
  • Importing and exporting clinical trial material
  • Prepare packaging options for negotiations with clinical team
  • Manage IVRS development activities
  • Create close collaborations to meet key milestones in the clinical supply process including: decisions on clinical supply strategies and designs, delivery of comparators and approved documentation to support clinical supply production.
  • Demonstrates a strong consistent display of team behavior by actively participating in project-related teams and is accountable for supply related component
  • Possess a high level of problem solving skills and use them to monitor key milestones in the global clinical supply process
  • Advise team of resource constraints and recommend strategies which will influence the ability to meet existing or anticipated demands
  • Recommend and implements ways to improve the efficiency of clinical supply processes

Requirements

  • BS/MS in science with experience in the pharmaceutical industry
  • Understanding of the drug supply, distribution and packaging process
  • Previous experience in cold-chain management and the use of TempTale technology
  • Demonstrated ability to work with people/teams in a fast-paced, complex, changing environment for the timely delivery of clinical supplies
  • Ability to effectively communicate and persuade others to accomplish goals and objectives
  • Must have strong problem solving skills, broad computer program literacy, including MS Word and Excel
  • Knowledge of the global clinical supply and clinical study processes, of cGMP and GCP regulations, ICH Guidelines as it relates to Good Distribution Practices (GDPs) and local country drug shipment regulations
  • Project planning skills to meet tight timelines
  • Effective communication and knowledge of how to impact and influence people
  • Excellent interpersonal skills
  • Self-motivated with a proven ability to organize project activity to meet multiple project timelines

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