Clinical Systems Analyst - TMTT
- Irvine, CA
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
- 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 systems
Full 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
E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Back to top