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

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

Competitive salaries
Performance-based incentives
Wide variety of benefits programs to address diverse individual needs of employees and their families