Job Description
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 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 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 EDC (Electronic Data Capture)
What else we look for (Preferred): - Proven expertise in Microsoft Office Suite
- Advanced Excel skills (pivot tables and formulas)
- Microsoft Power BI
- Project management skills
- Lead cross functional meetings
- Experience with Medidata RAVE
- 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.
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.
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). 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 Requirement Edwards 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 Corporation
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