Clinical Data Management Analyst
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.
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
As the Clinical Data Management Analyst, you will 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. The successful candidate will conduct all clinical data management functions (lead clinical study set-up, migrations, conduct/maintenance to database lock).
This is a hybrid role (office and remote blend). Selected candidate must reside within a reasonable distance from the Irvine Corporate location and have ability to commute on required onsite days.
How you will make an impact:
Create moderately complex metrics to identify trends in data and remediation, utilizing tools (e.g., systems, reports) to assess need for training and provide basic recommendations to improve data status during study conduct.
Evaluate data errors and collection issues; provide guidance and recommendations to clinical team for resolution.
Define and specify clinically 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 a cohort or project to bring clinical studies on-line, including conducting project team meetings, establishing, and maintaining project timelines, and communications to stakeholders.
Maintain and develop assigned sections of Data Management deliverables including data management plans (DMPs), training materials and user aids in compliance with regulations.
Perform Site/User Administration to allow access to the database, ensuring all users are qualified to access data base.
Participate in 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 duties as assigned by leadership
What you'll need (Required):
Bachelor's Degree in related field with 3 years’ of previous related work experience in clinical data management including clinical research and/or clinical study data entry OR equivalent work experience based on Edwards criteria
Experience with EDC (Electronic Data Capture) systems
What else we look for (Preferred):
Full knowledge of processes and procedures in clinical data management
Full knowledge of protocols, DMPs, and SAPs
Medidata RAVE
Ability to manage competing priorities in a fast-paced environment
Proven expertise in Microsoft Office Suite (Advanced in Excel)
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
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
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 (CA), the base pay range for this position is $85,000 to $115,000 (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.
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