Overview In this role you support clinical trial monitoring and data review under the supervision of the Clinical Scientist/Study Responsible Physician. You are part of the study work group, ensuring data quality and timely safety reporting. You coordinate data-related activities and assist with external data requests across trial phases. The position offers exposure to cross-functional teams and contributes to study timelines and regulatory deliverables.
Responsibilities- Assist with activities as assigned by the Clinical Scientist or Study Responsible Physician to support monitoring and reporting of clinical trials
- Be a member of the clinical Work Group for each assigned study
- Assist with study-specific data review activities in support of database locks
- Support monthly medical monitoring data review activities
- Assist/Coordinate activities in support of external data requests
- Other activities as determined by study team and phase of trial (start-up, execution or close out)
Key requirements- Bachelor's degree (or equivalent) required with 1-2 years relevant work experience preferred
- Bachelor's degree in a scientific discipline or nursing preferred; Masters (or equivalent) considered but not required
- Good organizational skills and strong written and verbal communication
- Excellent independent time management and ability to plan and track deliverables
- Ability to work in a dynamic environment and prioritize changing business needs
- Proficient in Microsoft Office applications (Excel, PowerPoint, Word) and Internet use
- Good organizational skills
- Strong written and verbal communication
- Independent time management
- Proficient Microsoft Office applications (Excel, PowerPoint, Word)
- Data review and monitoring
- Coordination of external data requests
