Head of Asset Management

6 days ago

London, Greater London, United Kingdom WEP Clinical Full time
Job Title: Head of Asset Management

Department: Project Management - Expanded Access Programs / Post-Approval Named Patient Programs

Location: Hybrid/Onsite

WEP Clinical is a market leader in Expanded Access Programs (EAP) & Post-Approval Named Patient Programs. We are a team of experts with over 15 years of experience, having distributed medicines in over 120 countries worldwide. We pride ourselves on having a global reach while maintaining local knowledge.

Key Responsibilities:
  • Execute project plans for new EAP programs, serve as the central point of contact for the EAP client and 3rd party vendors, and assist the drug safety team per the project-specific safety management plan.
  • Setup & close-out of the Clinical Trial Management System (CTMS), and the Electronic Trial Master File (eTMF), prepare study files based on project scope including maintenance of internal or external document storage systems and maintain program, site, and patient-level data into the CTMS.
  • Lead internal and external teleconferences, project Kick Off Meetings, and weekly check-ins with project team members.
  • Liaise with the Quality Assurance team to initiate and conduct program-related investigations, CAPAs, and conduct routine audits as well as submit and perform central IRB applications.
  • Oversee the development of project-level documentation and CRFs, ensuring updates are made as needed throughout the program.
  • Supervise, train, and mentor internal applicable project team members, and provide protocol-related training to EAP investigators and site staff.
  • Oversee the EAP program budget and scope of work to ensure on-time, on-budget performance and deliverables according to Clinical Study Agreements.
Requirements:
  • Bachelor's Degree (In a health or science field preferred)
  • Prior experience in clinical research, data management, or regulatory affairs, with at least two (2) years of experience in the monitoring and management of clinical research projects is a plus
  • Computer literacy and proficiency in Microsoft Office
  • Ability and willingness to travel up to 20% of the time
  • Leadership and management skills
What We Offer:
  • Competitive salary and benefits package including comprehensive health insurance, discretionary annual bonuses, personal development allowance, pension schemes, summer hours, company socials and more
  • Flexible working arrangements; including hybrid working from home and our UK headquarters

WEP Clinical is a specialist services company that partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over a decade of experience distributing products worldwide to treat unmet patient needs.

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