Job Information
Edwards Lifesciences Senior Clinical Data Analyst, Clinical Data Management in Irvine, California
This is an exciting opportunity for you to join a team boldly designing transcatheter mitral and tricuspid therapies from the ground up. Edwards’ Transcatheter Mitral and Tricuspid Therapies team is deeply dedicated to solving the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients’ lives around the world. This position is a full-time benefited role with bonus.
The Sr. Clinical Data Analyst, Clinical Data Management , 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.
This position is open to Hybrid or Remote. Headquarters located in Irvine, CA.
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 (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.
Minimum Qualifications
Bachelor's Degree
Minimum 5 years’ experience of previous related experience in clinical research including clinical data management and/or clinical data entry Required or
Experience with EDC (Electronic Data Capture) systems Required
General Expectations
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 organization
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.
The base pay range for this position is $101,000 to $142,000 (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.