Overview
In this role you drive the CSAI function from study start-up to database lock, delivering scientific insights and data visualization to support data cleaning and interpretation in oncology-focused trials. You act as a subject-matter expert translating clinical knowledge into study data reviews and operational guidance for cross-functional teams. You lead CSAI services within study scopes, shaping data capture, review processes, and UAT to ensure high-quality study deliverables. You will collaborate across departments, manage risks, and support training and process improvements to uphold Precision’s standards.
Responsibilities
- Lead the CSAI function on assigned projects per SOW
- Advise project teams on scientific data capture, review, and cleaning
- Develop and implement cross-functional data cleaning processes across departments
- Oversee data cleaning timelines and interim/final deliverables
- Coordinate Medical Monitor data reviews and scientific input for eCRF specs and edit checks
- Provide scientific input for EDC UAT and CSAI programming needs
- Communicate data review trends and CSAI needs to internal teams
- Identify study risks and manage CSAI-specific deficiencies
- Support CSAI budgeting, invoicing, and resource planning
- Maintain CSAI project plans, guidelines, and trackers
- Ensure eTMF documentation related to CSAI is complete
- Conduct holistic data reviews using programmed outputs (e.g., Smart Patient Profiles)
- Oversee and resolve queries in EDC systems
- Provide status updates on data review findings and issue escalation
- Lead CSAI UAT and development of CSAI outputs
- Deliver study-specific training for CSAI staff and sites
- Participate in study meetings and present CSAI topics
- Support data-related committees and sponsor interactions
- Contribute to SOP development and departmental trainings
- Support process improvement initiatives
- Perform other duties as assigned
Key requirements
- Bachelor’s degree in science or health-related field
- Minimum 8 years of clinical research experience
- Minimum 1 year of leadership experience
- Experience with electronic data capture systems
- Experience with Microsoft Office products (Outlook, Word, Excel, PowerPoint)
- Excellent communication and interpersonal skills
- Strong organizational skills and attention to detail
- Professional English (written and spoken)
- Ability to travel domestically and internationally occasionally
- strong communication
- organization and attention to detail
- customer service demeanor
- EDC systems experience
- data visualization software such as JReview
- statistical or data review capabilities
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