Edwards Lifesciences Clinical Systems Analyst - TMTT in Irvine, California
This is an exciting opportunity for you to join a team boldly designing transcatheter mitral and tricuspid therapies from the ground up. Edwards’ Transcatheter Mitral and Tricuspid Therapies team is deeply dedicated to solving the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients’ lives around the world.
The Clinical Systems Analyst will optimize processes with regards to computerized systems used within BU Clinical Affairs including Clinical Trial Management Systems (CTMS), Electronic Trial Master File (e.g., Veeva eTMF), and other systems as they become needed. Partner with IT to drive our clinical system implementations and enhancements.
Lead portions of system related process activities to support rollout and optimization of clinical systems, reporting tools, and associated processes. Assess project performance to monitor the progress of the project, identify and quantify variances, perform required corrective actions and communicate to all stakeholders
Partner closely with business users and Clinical IT on the specification, documentation, validation, and implementation of clinical systems optimization projects. Ensure documentation and validation practices are consistent with company policies.
Develop and facilitate clinical systems training. Act as the Clinical point of contact and Subject Matter Expert of clinical systems to business users. Assess knowledge and/or quality gaps of clinical staff and determine appropriate training plans and/or needs in collaboration with trial management.
Assist with system upkeep activities and eTMF related activities as needed (e.g. setting file folders within eTMF, CTM updates)
Review, develop, and manage workflow and work process standards to ensure that clinical systems activities are in compliance with the regulatory and company requirements. Reviews and edits work instructions.
Mentor and provide guidance to lower level clinical systems staff and contractors.
Additional duties or projects as assigned
Education and Experience:
Bachelor's Degree in related field with 5 years of experience in the clinical research field required.
Experience implementing or supporting clinical systems in a clinical research or clinical data management environment Required
Experience with Veeva Vault ETMF and Medidata CTMS preferred
Experience in the medical device industry Preferred
Strong knowledge of Veeva eTMF and Clinical Trial Management Systems (CTMS) systems including the ability to adapt to new technologies and rapidly changing environment
Demonstrated competency managing projects from inception to completion
Excellent written and verbal communication skills and interpersonal relationship skills
Demonstrated problem-solving and critical thinking skills, attention to detail, and performance of duties with minimal supervision
Full knowledge and understanding of Edwards policies, procedures, and regulatory guidelines relevant to clinical systemsFull understanding of regulatory policies relating to software used in the conduct of clinical trials.
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 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.