Project Specialist

WEP Clinical; United Kingdom; On-site; GBP 32,000 - 42,000; Full time

Benefits offered by this job

Private Medical Insurance

Life Assurance

Critical Illness and Pension

Education Allowance

Volunteer Day

Job summary

WEP Clinical Inc. is seeking a dedicated Project Specialist to support the setup, implementation, and management of Expanded Access Programs (EAPs).

You will help maintain trial master files, CTMS data, and regulatory submissions while coordinating with project, supply chain, and finance teams. The role requires a health or science background and 1–3 years in project management or clinical research, with strong communication skills and proficiency in Microsoft Office.

Qualifications

• Bachelor degree in health or science required.
• 1-3 years in project management or clinical research.
• Strong verbal and written communication skills.
• Proficient in Microsoft Office and general computer literacy.
• Ability to handle confidential information with discretion.

Responsibilities

• Assist with development and execution of Expanded Access Programs (EAPs).
• Coordinate with project management to meet client expectations.
• Collaborate with supply chain to coordinate shipments of investigational products.
• Support project and finance teams with vendor invoices for EAPs.
• Maintain sponsor and site contact lists.
• Communicate with sites for EAP enrollment and maintenance.
• Organize program-level documents in OneDrive/SharePoint.
• Collect and review site documentation to meet FDA/GCP/ICH requirements.
• Prepare Investigational Product Review Forms (IPRFs) for regulatory review.
• Support study file preparation and documentation storage (eTMF).
• Enter and maintain program, site, and patient data in CTMS.

Skills

Team Player

Adaptable

Detail Oriented

Problem Solver

Education

Bachelor’s degree in health or science field

Tools

Microsoft Office

Job description

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

What We Offer

• Group Private Medical Insurance
• Group General Life Assurance
• Group Critical Illness and Group Income Protection
• Salary sacrifice pension scheme
• Enhanced maternity & paternity pay
• Educational Assistance allowance
• Paid volunteering day

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 personalised service of a specialised 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, 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.

How We Work At WEP Clinical

At WEP Clinical, we look for individuals who are conscientious, exercise sound judgement, 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/Job-Applicant-Privacy-Notice/

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.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgement. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.