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Project Specialist
WEP Clinical. Assist with the development and execution of Expanded Access Programs (EAPs) .
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Assist with the development and execution of Expanded Access Programs (EAPs)
- Work with the project management team to complete projects according to client expectations
- Coordinate and dispatch investigational product shipments with the supply chain team according to WEP Clinical SOPs
- Support the project and finance teams with filing vendor invoices for EAPs
- Maintain sponsor and site contact lists
- Communicate with sites regarding EAP enrollment and maintenance
- Organize and maintain shared program-level documents in internal OneDrive or SharePoint
- Assist with collecting and reviewing project documentation from investigational sites for FDA/GCP/ICH compliance
- Prepare Investigational Product Review Forms (IPRFs) and submit them to the WEP Clinical Regulatory team
- Support preparation and maintenance of study files and electronic trial master files (eTMF)
- Enter and maintain program-, site-, and patient-level data in the EAP Clinical Trial Management System (CTMS)
Requirements
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
- Resume must be submitted in English
Benefits
Comp & perks- 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
- Wellness, growth, development, and team relationship initiatives
- Team events
- Inclusive, supportive work environment