Edwards Lifesciences Senior Clinical Data Management, New Product Development - Transcatheter Heart Valve (Remote) in Los Angeles, California
This is an exciting opportunity within a company that leads the heart valve market, not only in terms of market share but also in cutting edge technology. The Transcatheter Heart Valve (THV) team extends Edwards’s leadership into the transcatheter area, providing immediate new treatment alternatives to patients with no or few other alternatives, eventually positioning THV as the treatment of choice for aortic stenosis.
The Senior Clinical Data Manager – THV New Product Development will work together with a group of highly motivated clinical research experts in order to translate clinical study business requirements into actionable data that will be used as evidence to support our regulatory submissions and bring products to the market. All ensuring the quality and integrity of data collected, the privacy of patient data and efficient recording and reporting of safety related issues for their assigned Clinical studies.
**This position is either located in our Irvine, CA office or remote anywhere in the USA
Create complex metrics to identify trends in data and remediation, utilizing tools (e.g., systems, reports) to assess need for training and provide recommendations to improve data status during study conduct
Define and specify clinically complex data collection requirements (e.g., eCRFs, CRFs, edit checks and collection of external data) for assigned studies; including defining, performing, and coordinating user acceptance testing (e.g. test scripts and checklists) to ensure appropriate data are collected
Lead project management activities for multiple (multi-site and multi-cohort) projects to bring clinical studies on-line, including conducting project team meetings, establishing and maintaining project timelines, and communications to stakeholders
Develop and maintain Data Management deliverables including data management plans (DMPs), training materials and user aids in compliance with regulations
Evaluate data errors and collection issues; provide guidance and recommendations to clinical team for resolution
Perform Site/User Administration to allow access to the database, ensuring all users are qualified to access data base; may provide guidance on more complex access rights for users
Lead development and review of SOPs, work instructions, and associated documents for CDM, including recommending revisions and updates to SOPs, participating in the development of user training
Bachelor’s degree with five years’ experience in Clinical Data Management in the medical device, pharmaceutical, or biotechnology industry
Experience with Medidata Rave EDC (Electronic Data Capture) system required
Ability to understand protocols, data management plans (DMPs), and statistical analysis plans (SAPs) and to collaborate effectively with the Clinical study teams
Knowledge and understanding of policies, procedures, and guidelines relevant to clinical research
Knowledge of processes and procedures in clinical data management
Experience in Interventional Cardiology clinical studies from inception to PMA submission
Ability to bring a meaningful difference to the treatments we develop
Excellent written and verbal communication skills, analytical skills, strong organizational skills, self-motivated, flexibility and adaptability
Proficient in Microsoft Office Suite
Basic project management skills
Excellent problem-solving and critical thinking skills
Ability to manage competing priorities in a fast-paced environment
Strict attention to detail
Must be able to work in matrix organizations, representing both your functional and the study teams on specific projects
Ability to build productive internal/external working relationships
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 15,000 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.