The Clinical Data Lead/Analyst in Edwards LifeSciences translates Clinical study business requirements into system requirements for the collection and management of data from Clinical trials. Ensuring 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 (such as 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.

　　• 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 project management activities for multiple complex (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

　　• 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

　　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 , 4 Years years experience of previous experience Required

　　• 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

　　What is it like to work at Edwards Lifesciences?

　　As a global leader in patient-focused medical innovations, we offer rewarding opportunities and exciting challenges in a truly international, dynamic and friendly work environment.

　　We are committed to fostering a diverse and inclusive work environment where all employees can grow, personally and professionally. To achieve this, we offer on-the-job development, training opportunities and the support and guidance provided by dedicated employee groups (the Edwards Network of Women, Edwards Foundation charity team, sustainability activities, and others).

　　Edwards Lifesciences also offers the following benefits:

　　Competitive Compensation and Benefits packageFlexible working hours, remote workingPension Plan Risk Life InsuranceService AwardsEnhanced Sick Leave BenefitsEmployee Stock Purchase ProgramEmployee Assistance ProgramComprehensive Wellness Program, workshops, educational events, charity activities and much more.