EAP Project Specialist - Clinical Trials & Delivery

Lever, Inc.; United Kingdom; Remote; GBP 28,000 - 45,000; Full time

Benefits offered by this job

Private medical insurance

Life assurance

Critical illness and income protection

Salary sacrifice pension scheme

Enhanced maternity & paternity pay

Educational assistance

Volunteer day

Job summary

WEP Clinical is seeking a Project Specialist to provide operational and administrative support for Expanded Access Programs (EAPs). You will help manage trial master files, CTMS data, and regulatory documentation, while supporting cross-functional teams to exceed client expectations.

The role requires a health/science background, 1–3 years in project management or clinical research, and strong communication and organizational skills.

Qualifications

• Bachelor’s degree in health or science preferred.
• 1–3 years’ project management or clinical research experience.
• Strong communication and organizational skills.
• Ability to handle confidential information with discretion.

Responsibilities

• Assist with development and execution of EAPs.
• Collaborate with PM to ensure projects meet client expectations.
• Coordinate shipments of investigational products per SOPs.
• Support project and finance with filing vendor invoices.
• Maintain sponsor and site contact list.
• Communicate with sites for EAP enrollment and maintenance.
• Organize program documents in OneDrive/SharePoint.
• Collect/review site documentation to meet FDA/GCP/ICH.
• Prepare Investigational Product Review Forms (IPRFs) for Regulatory.
• Support study file prep, eTMF storage systems.
• Enter and maintain data in EAP CTMS.

Skills

Verbal communication

Written communication

Attention to detail

Organizational skills

Discretion

Education

Bachelor’s degree in health or science

Tools

Microsoft Office

Job description

WEP Clinical is seeking a Project Specialist to provide operational and administrative support for Expanded Access Programs (EAPs). You will help manage trial master files, CTMS data, and regulatory documentation, while supporting cross-functional teams to exceed client expectations.

The role requires a health/science background, 1–3 years in project management or clinical research, and strong communication and organizational skills.