Edwards Lifesciences Associate Analyst, Core Lab Management in Irvine, California
Identify technical and data issues and collaborate with appropriate team members to bring to resolution; Determine root cause and recommend and implement corrective actions
Analyze clinical output of highly 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, develop, recommend, and lead implementation of 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.).
Provide guidance and represent department to communicate risk and impact to study core team's key milestones and deliverables
Field and remote monitoring of studies and data collection for clinical trials with increased volume and complexity (e.g., Core Labs), assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial documentation is within parameters of study protocol, as well as to monitor clinical trial, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements
Develop 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.
Bachelor’s degree with minimum 1 year experience in clinical research related experience
Excellent computer skills in usage of MS Office Suite including Excel and MS Project, as well as electronic data capture systems
Excellent written and verbal communication skills and interpersonal relationship skills including consultative and relationship management skills
Excellent problem-solving and critical thinking skills
Full understanding and knowledge of principles, theories, and concepts relevant to clinical trial management
Full knowledge of human anatomy and physiology
Excellent problem-solving, organizational, analytical and critical thinking skills
Good leadership skills and ability to influence change
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
Ability to interact with senior internal and external personnel, inclusive of key opinion leaders (KOL) on significant matters often requiring coordination between organizations
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.