AI expert managing predictive modeling and statistical validation for TEHORA. Integrating predictive models into API architecture and producing performance metrics.
About the role
- Senior Clinical Data Manager at Edwards Lifesciences managing clinical study data quality and database operations. Leads study set-up, metrics, UAT, DMPs, and cross-functional project management.
Responsibilities
- Ensure the quality and integrity of data collected in clinical studies and the privacy of patient data
- Ensure efficient recording and reporting of safety-related issues
- Conduct all clinical data management functions (lead clinical study set-up, migrations, conduct/maintenance to database lock)
- Create complex metrics to identify trends in data and remediation and utilize tools/reports to assess training needs
- Define and specify clinically complex data collection requirements (eCRFs, CRFs, edit checks, collection of external data)
- Define, perform, and coordinate user acceptance testing (test scripts and checklists)
- Lead project management activities for multiple multi-site and multi-cohort projects, including team meetings, timelines, and stakeholder communications
- Develop and maintain Data Management deliverables including data management plans (DMPs), training materials and user aids
- Evaluate data errors and collection issues and provide guidance and recommendations for resolution
- Perform Site/User Administration for database access and ensure users are qualified
- Lead development and review of SOPs, work instructions, and associated CDM documents and participate in user training
- Perform other incidental duties assigned by Leadership
Requirements
- Bachelor's degree and 5 years of previous related experience in clinical research including clinical data management and/or clinical data entry OR Associate degree or equivalent in a related field and 7 years of previous related experience in clinical research including clinical data management and/or clinical data entry
- Experience with Medidata Rave EDC (Electronic Data Capture)
- Minimum of 2 years leading clinical studies combined with 5 years of relevant experience in clinical research (preferred)
- Full knowledge of protocols, DMPs, SAPs, Database Specification, and Data Validation Specification (preferred)
- Proven expertise in Microsoft Office Suite (preferred)
- Advanced Excel skills (pivot tables and formulas) (preferred)
- Microsoft Power BI (preferred)
- Project management skills and ability to lead cross-functional meetings (preferred)
- Full knowledge of processes and procedures in clinical data management (preferred)
- Excellent written and verbal communication and interpersonal relationship skills, including negotiating and relationship management skills (preferred)
- Excellent problem-solving and critical thinking skills (preferred)
- Ability to work in a team environment and interact with senior internal and external personnel (preferred)
- Must reside within a reasonable distance from the Irvine Corporate location and have ability to commute on required onsite days
Benefits
- Competitive salaries
- Performance-based incentives
- Wide variety of benefits programs to address diverse individual needs of employees and their families
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