Edwards Lifesciences Senior Clinical Data Manager, Transcatheter Heart Valve (THV) in Newark, New Jersey
The Senior Clinical Data Manager will translate Clinical study business requirements into system requirements for the collection and management of data from Clinical trials. Ensure the quality and integrity of data collected in Clinical studies, the privacy of patient data and efficient recording and reporting of safety related issues.
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.
Job Functions :
Create, augment or modify complex metrics to identify means of tracking data quality, completeness and trends in data and remediation, utilizing tools (e.g., systems, reports) for planning, internal data review, go/no-go decisions and external publications or data submissions.
Design, create, configure and maintain complex clinical study database to define data collection instruments (e.g., eCRFs, edit checks and collection of external data); including performing, and/or coordinating user acceptance testing to ensure appropriate data are collected. Perform required documentation of these activities.
Lead CDM project management activities for multiple (multi-site and multi-cohort) projects to bring clinical studies on-line, including, but not limited to, conducting project team meetings, establishing and maintaining project timelines, and communications to stakeholders.
Develop and maintain Data Management deliverables including data management plans (DMPs), CRF completion guidelines, training materials and user aids in compliance with study design and regulations.
Evaluate data errors, trends and collection issues; present findings/recommendations to clinical teams and management for resolution.
Support EDC system User Administration to ensure all users are qualified to access data base; may provide guidance on more complex access rights for users.
Participate in cross-functional non-study specific projects to represent the CDM department and provide functional expertise to the project team.
Contribute to the ongoing development and improvement of department procedures by being the primary author, actively contributing to or leading process discussions.
Other incidental duties assigned by Leadership
Bachelor’s degree with 5 years of related experience in clinical research, including clinical data management
Experience with EDC systems, preferably Medidata Rave
Experience in some reporting tool, such as Business Object, QlikView, Crystal Reports, Power BI, Tableau, etc
Working knowledge of other clinical systems (such as CTMS, Coder, Veeva Vault eTMF, etc.) a plus
Knowledge of data science principles or experience in data analytics a plus
Proven expertise in Microsoft Office Suite, especially Excel and PowerPoint
Basic project management skills
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills
Excellent problem-solving and critical thinking skills
Full knowledge and understanding of policies, procedures, and guidelines relevant to clinical research
Full knowledge of processes and procedures in clinical data management
Full knowledge of protocols, DMPs, and SAPs
Ability to manage competing priorities in a fast-paced environment
Strict attention to detail
Must be able to work in a team environment, including cross-departmental teams and key contact representing the organization on projects
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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.
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