Project Specialist EAP

WEP Clinical; City of Westminster; On-site; GBP 30,000 - 45,000; Full time

Job summary

A leading clinical research organization in the United Kingdom seeks a Project Specialist to provide operational and administrative support for Expanded Access Programs. Responsibilities include managing trial documentation and ensuring customer satisfaction. Candidates should have a bachelor's degree in a health or science field and 1-3 years of relevant experience. Join a mission-driven team dedicated to improving patient outcomes through enhanced access to medicines.

Benefits

Wellness initiatives

Growth and development opportunities

Team events

Qualifications

• 1-3 years of experience in project management or clinical research.
• Effective verbal and written communication skills.
• Ability to handle confidential information with complete discretion.
• Strong organizational skills and attention to detail.

Responsibilities

• Assist with the development and execution of clinical research programs.
• Work with project management to ensure projects meet client expectations.
• Coordinate and dispatch shipments of investigational products.
• File vendor invoices for programs.
• Maintain sponsor and site contact lists.

Skills

Adaptable

Detail Oriented

Team Player

Great Communicator

Education

Bachelor's degree in a health or science field (preferred)

Tools

Microsoft Office

Job description

Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives. Role Objectives: The WEP Clinical Project Specialist is responsible for providing operational and administrative support throughout the setup, implementation, and management of Expanded Access Programs (EAPs). Key responsibilities include maintaining, organizing, and reviewing electronic trial master files (eTMF), managing clinical trial management systems (CTMS), and supporting the team to consistently exceed client expectations.,

Responsibilities

• Assist with the development and execution of clinical research programs, including 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 programs.
• Maintain the sponsor and site contact list.
• Communicate with sites for enrolment and maintenance as needed.
• Organise and maintain shared program-level documents within internal OneDrive or SharePoint.
• Assist with project documentation collection and review from investigational sites.
• Prepare Investigational Product Review Forms (IPRFs) and submit them to the WEP Clinical Regulatory team.
• Supported the 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 Clinical Trial Management System (CTMS).

Qualifications

• Adaptable
• Detail Oriented
• Team Player
• Great Communicator
• Bachelor's degree in a health or science field (preferred).
• 1-3 years of experience in project management or clinical research.
• 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.

Company Overview

WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.

Benefits & Culture

We're Committed to Our Team: WEP has many initiatives to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events, and all that we do to support our employees. We're Committed to DEI: At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.