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.This role can be either an onsite or hybrid role based at Edwards’ Irvine campus, or a remote-based role in the U.S.How you will make an impact:The Senior Clinical Data Manager - Transcatheter Heart Valve business unit will translate clinical study business requirements into system requirements for collecting and managing data from Clinical trials. The successful candidate will ensure the quality and integrity of data collected in Clinical studies, the privacy of patient data, and the efficient recording and reporting of safety-related issues. He/she 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 regulationsEvaluate 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 and 5 years of previous related experience in clinical research including clinical data management and/or clinical data entry
OR
Associate degree or equivalent in a related field and 7 years of previous related experience in clinical research including clinical data management and/or clinical data entry
AND
Experience with Medidata Rave EDC (Electronic Data Capture)
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.
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.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). Applications will be accepted while this position is posted on our Careers website.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.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.