The Role
Support setup, implementation, and management of Expanded Access Programs (EAPs). Maintain eTMF and CTMS records, coordinate investigational product shipments, file vendor invoices, manage sponsor/site contact lists, communicate with sites for enrollment, prepare IPRFs for regulatory, and ensure documentation meets FDA/GCP/ICH requirements. Maintain shared documents in OneDrive/SharePoint and enter program/site/patient-level data.
Summary Generated by Built In
Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical and play a vital role in the successful management of Expanded Access Programs (EAP). We challenge our team to bring thought-provoking ideas to the table and to help define and drive solutions for clients and patients. Join us in our mission to improve patient outcomes and make a difference in the field of clinical research.
Role Objectives:
As a Project Specialist at WEP Clinical, you will be responsible for the operational and administrative support of the setup, implementation, and management of Expanded Access Programs (EAPs). Your responsibilities will include maintaining, organizing, and reviewing electronic trial master files, clinical trial management systems, and supporting the team in exceeding client expectations.
The Ideal Candidate:
- Team Player
- Adaptable
- Detail Oriented
- Problem Solver
What You'll Do:
- Assist with the development and execution of EAPs.
- 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 EAPs.
- Maintain the sponsor and site contact list.
- Communicate with sites for EAP enrollment 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).
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
- Ability to remain in a stationary position for extended periods as part of normal day-to-day activities, with reasonable accommodations considered where appropriate
Location eligibility applies. Candidates must reside in a U.S. state where the company is authorized to hire. This role is not eligible for residents of: California, Colorado, New York, Washington, New Jersey, Massachusetts, Illinois, Hawaii, and District of Columbia.
What We Offer:
Medical, dental, and vision insurance
FSA, HSA
Voluntary Critical Illness, Hospital Indemnity, and Accident Insurance
Group short-term and long-term disability insurance
Group Life Insurance
401K safe harbor plan and company match
Paid vacation, holiday, sick and volunteer time
Paid maternity & paternity leave
What Sets Us Apart:
WEP Clinical partners with biopharmaceutical Sponsors to help them bring treatments closer to the patients who need them most. Through end-to-end clinical trial delivery, home health services, expanded access programs, and market access consultancy, we provide flexible, fit-for-purpose solutions that support drug development, improve access, and help therapies reach the right patients at the right time. With more than 15 years of global experience, we have supported programs across 150+ countries, combining operational scale with the agility and personalized service of a specialized provider. Our work helps bridge critical gaps in care, ensuring safe, ethical, and efficient access to promising new treatments.
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 we do to support our employees.
How We Work at WEP Clinical:
At WEP Clinical, we look for individuals who are conscientious, exercise sound judgment, and engage with others thoughtfully and professionally. We believe excellence is achieved through integrity, accountability, and respect for diverse perspectives - and we are committed to helping our people grow and succeed in an inclusive, supportive environment.
Our Services Include:
Access Programs
Clinical Trial Services
Patient Site Solutions
Clinical Trial Supply
Market Access and Commercialization
Data Privacy Notice:
WEP Clinical is committed to protecting your personal information throughout the recruitment process. By applying, you acknowledge that your personal data will be processed in accordance with our Privacy Policy and Job Applicant Privacy Notice.
Privacy Policy: https://www.wepclinical.com/privacy-policy/
Job Applicant Privacy Notice: https://www.wepclinical.com/privacy-policy/
How to Apply:
To be considered for this role, please submit your resume through the WEP Clinical Careers Portal or by using LinkedIn’s Easy Apply option. Please ensure your resume is in English.
Important Note:
To streamline our hiring process, we use an Upwage AI screener. If you receive a link from Upwage, it is a legitimate part of our application process and helps ensure every candidate is reviewed consistently. If you are selected to move forward after the screener, a member of our team will contact you directly from an @wepclinical.com email address to guide you through the next steps of the interview process. Please ensure you apply only through our official careers page (https://www.wepclinical.com/careers/) or our verified LinkedIn page.
For Your Safety, Please Note:
We will never communicate with you via Microsoft Teams or text message.
We will never ask for your bank account information at any stage of recruitment.
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.
#LI-fulltime
Skills Required
- Bachelor's degree
- Bachelor's degree in a health or science field
- 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
- Ability to remain in a stationary position for extended periods (with accommodations as appropriate)
- Reside in a U.S. state where the company is authorized to hire (not eligible: CA, CO, NY, WA, NJ, MA, IL, HI, DC)
- Resume must be submitted in English
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The Company
What We Do
We are a rapidly growing niche pharmaceutical services company operating in four key sectors:- Managed Access Programs (MAP) Unlicensed Medicines Access Clinical Trial Sourcing Reference Product Supply. Our goal is to provide positive measurable outcomes to patients and sponsors but above all else we want to be known as your “trusted partner” and an extension of your team. •UK headquarters established in London in 2008. •US Headquarters established in Research Triangle Park, North Carolina in 2012. •Our team has many years of pharmaceutical, clinical and regulatory experience gained in companies such as Pfizer, AZ, MSD, GSK, UDG Healthcare, Waymade, Sanofi, Quintiles & Walgreens Boots Alliance. •Our facilities have been inspected & licensed by the MHRA, UK Home Office, FDA and all necessary local approval bodies. •We are also approved to handle and distribute controlled substances. •We are compliant with all relevant GMDP regulations and operate to a high standard of medicines supply. •We operate under a comprehensive Quality Management System with robust and compliant standard operating procedures (SOPs) and policies. •Our customers and partners include Pharma, Biotechs, Generic and Biosimilar Developers, CROs and Healthcare and Hospital authorities. •We are fully committed to a culture of continual development and strive to service our partners needs beyond their expectations We would be happy to answer any questions that you may have regarding WEP Clinical and our products and services.
