Project Specialist EAP

Overview

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.

The Ideal Candidate

• Team Player
• Adaptable
• Detail Oriented
• Great Communicator

What You\\\’ll Do

• 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.
• Support 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).

What You\\\’ll Need

• Bachelor’s degree (In a health or science field preferred).
• 1-3 years’ 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.

What We Offer

• Private healthcare insurance
• Long-term illness Cover
• Death in service cover
• Salary sacrifice pension
• Annual leave
• Paid maternity & paternity leave
• Volunteer day

What Sets Us Apart

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.

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.

Our services include

• Access Programs
• Clinical Trial Services
• Patient Site Solutions
• Clinical Trial Supply
• Market Access and Commercialization

WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.

WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual\\\’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.