8 am PST to 5 pm PST
As the Clinical Operations Analyst for our THV Core Labs team, you will be responsible for providing project management of dynamic and high-volume core lab projects across all THV global clinical studies to ensure accurate and timely transfer of images from study sites to Independent Core Labs, and clinical data from Independent Core Labs to data management teams to ultimately provide unbiased study results.
Key Responsibilities:
• Analyze clinical output of moderately complex studies and provide high level summary with supporting details of study trial status (e.g., Core Lab image perspective) to stakeholders and clinical management
• Identify technical and data issues and collaborate with appropriate team members to bring to resolution; assist in the determination of root cause and recommend and implement corrective actions
• Identify, develop, recommend, and implement moderately complex process development and process improvement solutions to optimize global trial workflow timelines, (e.g., open information requests, aging issues, status of image analysis from Core Labs to study database, etc.)
• Develop basic timeline assessment and/or work with senior level team members on complex timeline assessment (e.g., clinical site through Image workflow vendor to Independent Core Lab) in collaboration with clinical stakeholders in order to meet key study milestones and deadlines
• Provide guidance and represent department to communicate risk and impact to study core team's key milestones and deliverables
• Assist in the development of training material content in collaboration with clinical stakeholders for clinical sites and clinical field staff
Education and Experience:
- Bachelor's Degree in STEM or healthcare
- 3+ years of hands-on clinical research experience
Must haves:
- Clinical trial/research background with medical devices (If in a cardiovascular or clinical imaging setting, a plus)
- Track record of supporting 3 or more ongoing trials at one time
- Recent work experience with EDC Rave
- Highly skilled in Excel & SharePoint
- Experienced with interpreting clinical data