Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.

　　Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

　　How you will make an impact by:

　　As a Sr. Clinical Data Manager - Transcatheter Heart Valve will translate clinical study business requirements into system requirements for collecting and managing 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. The successful candidate will conduct all clinical data management functions (lead clinical study set-up, migrations, conduct/maintenance to database lock).

　　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.

　　What you'll need (Required):

　　Bachelor's Degree 5 years’ experience of previous related experience in clinical research including clinical data management and/or clinical data entry Required OR

　　Associate degree or equivalent in in related field, 7 years of previous experience Required and

　　Experience with EDC (Electronic Data Capture) systems. Medidata Rave

　　What else we look for (Preferred):

　　Proven expertise in Microsoft Office Suite

　　Advanced Excel skills (pivot tables and formulas)

　　Power BI

　　Basic project management skills

　　Full knowledge of processes and procedures in clinical data management

　　Full knowledge of protocols, DMPs, and SAPs

　　Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills.

　　Excellent problem-solving and critical thinking skills

　　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 company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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.

　　For California, the base pay range for this position is $103,000 to $146,000 (highly experienced).

　　The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

　　Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

　　COVID Vaccination Requirement

　　Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

　　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.