WEP Clinical

General

• Partner with cross-functional stakeholders to gather and translate business and technical requirements into scalable data solutions
• Develop and optimize SQL queries and support relational database design for data analysis and reporting
• Build Python-based scripts and automations to streamline workflows and improve operational efficiency
• Analyze data to identify trends and drive process improvements
• Present insights through dashboards such as Tableau for diverse audiences
• Support system enhancements and integration efforts, including testing and implementing new tools and AI-driven solutions
• Evaluate, test, and implement AI-enabled tools or solutions
• Support system integrations, enhancements, and optimization efforts under senior IT or data team guidance
• Prepare and maintain process maps, technical notes, and user guidance
• Participate in project meetings, provide status updates, and contribute to continuous improvement initiatives

IT Intern

• 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)

Project Specialist

Documentation Specialist

• Support electronic Trial Master File (eTMF) setup, maintenance, and closeout in accordance with WEP Clinical processes, sponsor requirements, and applicable regulations
• Collaborate with internal project teams to ensure timely retrieval, filing, and availability of essential documents
• Maintain systems and tools used to evaluate, track, and transmit TMF documents
• Conduct detailed quality checks and content reviews of eTMF documents, including required paper originals
• Generate and provide TMF metrics and content reports to project management teams and leadership
• Scan or coordinate scanning, label, upload, and appropriately file documents for traceability and accessibility
• Ensure adherence to privacy, security, and document retention standards
• Support TMF archival activities and long-term document storage strategies after project closeout
• Assist with internal and external TMF audits for compliance with SOPs, policies, FDA, and ICH GCP guidelines
• Maintain study status trackers and other project documentation tools
• Label, sort, categorize, and retrieve documents
• Assist with training staff on documentation practices
• Perform proofreading and administrative tasks as needed