Clinical Research Manager

5 hours ago

London, Greater London, United Kingdom WEP Clinical Inc. Full time
Company Overview:

Welcome to WEP Clinical Inc., a leading provider of expanded access programs, named patient programs, and clinical trial supplies. With over 15 years of experience in distributing products to over 120 countries worldwide, we have established ourselves as a trusted partner for sponsors and patients alike.

Salary: The estimated salary for this position is $60,000 - $80,000 per year, depending on location and experience.

Job Description:
We are seeking a highly motivated and detail-oriented individual to join our team as a Academic Specialist for English. As a key member of our project operations team, you will be responsible for the operational and administrative support of the setup, implementation, and management of Expanded Access Programs (EAPs), Open-Label Extension Studies (OLE), and Post Approval Named Patient Programs (PA-NPP). Your responsibilities will include maintaining, organizing, and reviewing electronic trial master files, clinical trial management systems, and supporting the team in exceeding client expectations.

Responsibilities:
  • Assist with the development and execution of clinical research programs, including expanded access and post approval named patient programs
  • Work with the project management team to ensure projects are completed in accordance with client expectations
  • Work with the supply chain team to coordinate and dispatch shipments of investigational products according to the WEP Clinical SOP's
  • Support the project team and finance team with filing vendor invoices for Expanded Access Programs
  • Maintain the sponsor and site contact list
  • Communicate with sites for EAP enrolment and maintenance as needed
  • Organize and maintain shared program-level documents within internal OneDrive or SharePoint
  • Assist with project documentation collection and review from investigational sites, ensuring they meet FDA/GCP/ICH requirements
  • Prepare Investigational Product Review Forms (IPRFs) and submit to WEP Clinical Regulatory team
  • Support preparation of study files based on project scope including maintenance of internal or external document storage systems including Electronic Trial Master File (eTMF)
  • Enter and maintain program, site, and patient-level data into the EAP Clinical Trial Management System (CTMS)

Required Skills and Qualifications:

To be successful in this role, you will need:

Education:
  • Bachelor's degree (In a health or science field preferred)
Experience:
  • 1-3 years' experience in project management or clinical research
Skills:
  • Effective verbal and written communication skills
  • Computer literacy and proficiency in Microsoft Office
  • Ability to handle confidential information with complete discretion
  • Strong organizational skills and attention to detail

Benefits:

As a valued member of our team, you will enjoy a range of benefits, including:

Professional Development:
  • Ongoing training and professional development opportunities
Wellness:
  • A smoke-free, drug-free, and alcohol-free work environment
Recognition:
  • Regular recognition and reward for outstanding performance

What Sets Us Apart:

At WEP Clinical Inc., we pride ourselves on our commitment to excellence and our dedication to making a difference in the lives of patients and healthcare professionals. With over 15 years of experience in distributing products to over 120 countries worldwide, we have established ourselves as a trusted partner for sponsors and patients alike. Our services include expanded access programs, named patient programs, clinical trial supplies, and more.

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