Senior Analyst, Clinical Data Management

Regulatory Jobs; Irvine (CA); On-site; USD 108,000 - 153,000; Full time

Job summary

Edwards seeks a Clinical Data Management professional to join our Clinical Affairs team in Irvine. You will design and manage data capture, lead multi-site studies, and ensure data quality and regulatory compliance.

The role requires a Bachelor's degree with 5+ years in clinical research and EDC experience; familiarity with AI tools like Copilot and Claude is a plus, along with strong communication and project management skills.

Qualifications

• Bachelor’s degree in a related field with 5+ years of clinical research and data management experience.
• Experience with Electronic Data Capture (EDC) systems.

Responsibilities

• Creating complex metrics to identify trends in data and remediation, utilizing tools to assess training needs and improve data status during study conduct.
• Defining and specifying clinically complex data collection requirements for assigned studies and coordinating user acceptance testing.
• Leading project management activities for multi-site studies to bring clinical studies online, including meetings, timelines, and stakeholder communications.
• Developing and maintaining Data Management deliverables including DMPs, training materials, and user aids in regulatory compliance.
• Evaluating data errors and collection issues; providing guidance to clinical teams for resolution.
• Performing Site/User Administration to manage database access and user rights.

Skills

EDC experience

Data management

Communication skills

Project coordination

Education

Bachelor's degree

Tools

Copilot

Claude AI

Microsoft Office

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.

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.

How you will make an impact:

• Creating complex metrics to identify trends in data and remediation, utilizing tools (e.g., systems, reports) to assess need for training and providing recommendations to improve data status during study conduct.
• Defining and specifying 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.
• Leading 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.
• Developing and maintaining Data Management deliverables including data management plans (DMPs), training materials and user aids in compliance with regulations.
• Evaluating data errors and collection issues; providing guidance and recommendations to clinical team for resolution.
• Performing Site/User Administration to allow access to the database, ensuring all users are qualified to access data base; providing guidance on more complex access rights for users.
• Leading 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.

What you’ll need (Required):

• Bachelor’s Degree in related field with 5 years of previous related experience in clinical research including clinical data management and/or clinical data entry or equivalent work experience based on Edwards criteria.
• Experience with EDC (Electronic Data Capture)

What else we look for (Preferred):

• Experience with AI Tools (Copilot & Claude)
• Experience with study start-up, conduct, and close-out
• 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 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.

The base pay range for this position is $108,000 to $153,000 (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.