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Expanded Access Manager

Position Title: Expanded Access Manager

Position Summary:

We are seeking a self-starter with excellent interpersonal and organizational skills to join our growing clinical team. He / She will be responsible for managing Expanded Access Program (EAP), providing coordination support including status tracking, IP management, safety reporting, document management and data review activities in accordance with, regulatory requirements and Good Clinical Practice.

Responsibilities:

  • Assists in the selection, qualification, and management of vendors to support EAP execution
  • Assists in the development and management of EAP protocol, regulatory document collection, timelines and metrics; ensures timely and quality deliverables; provides status update reports
  • In partnering with Tech Ops, lead planning, forecasting and management of clinical supply (IP) for EAP
  • Monitors vendor shipments and endures inventory at both the depot and site level
  • Co-manages standardized return and destruction procedures as needed
  • Plans and executes sub team/cross functional meetings as needed
  • Reviews vendor oversight reports to ensure quality and resolution of site-related issues
  • Ensures tracking and review of IP deviations and assesses impact on study data
  • Assists with preparing basic summary reports, Serious Adverse Event/Adverse Event reconciliation for PVG for the sponsored clinical trials
  • Initiates and manages cross-functional meetings to ensure alignment with all program stakeholders
  • Assist in assessing product complaints and represent clinical on Product Complaint Team
  • Assists with retrieving safety summary reports for EAP
  • May serve as the point of contact for vendors and oversee day to day vendor activities

Competencies/Requirements:

  • Bachelor's degree in life sciences or related area
  • At least 3 years of relevant work experience in managing clinical trials and Expanded Access/Compassionate Use Program in a pharmaceutical or CRO environment
  • Strong project management foundation
  • Global and local expertise and experience managing Phase I through Phase IV trials
  • Excellent verbal and written communication
  • Working knowledge of ICH/GCP regulations and clinical protocols
  • Working knowledge of drug/device combination product is a plus
  • Demonstrated computer aptitude in MS Office Suite and other systems
  • Good working knowledge of management and oversight of CROs, IWRS and TMFs
  • Strong interpersonal, organizational and multi-tasking skills; attention to detail
  • Perform job duties with minimal supervision and guidance

If you or an Expanded Access Manager you know feel this could be an opportunity you would like to explore please send your most up to date resume to myself at Sara.Shields (at sign) Realstaffing.com to discuss this role.

Thank you!

Sthree US is acting as an Employment Agency in relation to this vacancy.