Clinical Assistant

Clinical Assistant
  • Competitive
    HOUR
  • Permanent
  • San Diego CA, US San Diego SAN DIEGO US 92130
Job Ref: JO000115527
Sector: Clinical
Sub-sector: Clinical
Date Added: 26 April 2021


Senior Clinical Supplies Specialist
SRG is looking for a Senior Clinical Supplies Specialist that would report into the Senior Director, Clinical Supplies and support activities related to Clinical Trial Material (Phase I - IV), collaborate with internal and external customers, & partner in compliance internally for GxP requirements along with multinational regulations.

Essential Functions:

  • Review and/or provide Clinical Trials Materials (CTM) supply forecasts based on projected needs of clinical trial study protocols.
  • Coordinate supply of CTM, based on study and drug forecasts, with Clinical, Manufacturing and Medical project managers, as well as contract distribution partners.
  • Review and manage contracts with appropriate internal and external partners.
  • Work collaboratively with other departments for the creation and approval of product labeling.
  • Hands-on management of the labeling and packaging operations with multiple vendors.
  • Support the development, implementation, and maintenance of IXRS systems of global clinical trials.
  • Process manual orders for CTM to be shipped by contractors for all studies operating outside of IXRS automated supply systems.
  • Maintain clinical supplies inventory for assigned projects by interfacing with vendors to ensure that inventory systems are kept up-to-date and that final product reconciliation is accurate.
  • Ensure that key supply project milestones are met while maintaining open communication on supply plan timelines with internal and external customers and partners.

Qualifications:

  • Bachelor Degree in life science or in a related field of study.
  • 4-5 years of clinical supplies experience including experience with drug planning / forecasting, packaging and labeling, global distribution, as well as clinical supply and cold chain management.
  • Strong understanding of QP requirements, EU GDPs, Annex 13, CFR and ICH guidelines, regulations and guidelines governing conduct of clinical studies.
  • Strong understanding of IXRS systems and generation of URS and UAT documentation.
  • Self-starter who works with a sense of urgency and acts as a good team player working with other disciplines.

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

SRGTalent
31/05/2021 12:00:00
USD 0.00 0.00 Hour
Contact Consultant:
Melissa Rodrigues

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