Edwards Lifesciences Sr Analyst, Clinical Data Mgmt (Tokyo) in Tokyo, Japan
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.
Key Responsibilities: • 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. • Other incidental duties assigned by Leadership
Education and Experience: Bachelor's Degree 5 years years experience of previous related experience in clinical research including clinical data management and/or clinical data entry Required or Associate's Degree or equivalent in in related field , 7 years years experience of previous experience Required and Experience with EDC (Electronic Data Capture) systems Required
Additional Skills: • Proven expertise in Microsoft Office Suite • 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 inter-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 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.