Senior Analyst, Clinical Operations

Edwards Lifesciences; Irvine (CA); On-site; USD 92,000 - 130,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA is seeking a Clinical Affairs professional to advance the clinical evidence supporting our therapies. You will work with investigators, medical professionals, patient groups and regulators to optimize study outcomes and access to our technologies.

Collaborating with study teams, you will assess data, develop training materials, and drive process improvements to shorten trial timelines while maintaining rigorous standards.

Qualifications

• Bachelor’s Degree in related field with 5 years of hands‑on clinical research experience.
• Experience in clinical trial management and regulatory interaction is preferred.
• Excellent written and verbal communication and strong analytical skills.

Responsibilities

• Identifying technical and data issues and collaborating with team members to resolve root causes.
• Analyzing clinical output of complex studies and providing high‑level summaries to stakeholders.
• Leading implementation of process improvements to optimize global trial workflows and information flow.
• Communicating risks and impacts to study core teams and milestones.
• Developing timeline assessments with clinical stakeholders to meet study deadlines.
• Creating training material content for clinical sites and field staff.
• Assessing knowledge gaps and determining training plans with management.

Skills

MS Office Suite

Communication skills

Problem solving

Trial management knowledge

KOL liaison

Education

Bachelor's Degree in related field

Tools

MS Project

MS Excel

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 under-treated. 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.

How you will make an impact:

• Identifying technical and data issues and collaborating with appropriate team members to bring to resolution; Determining root cause and recommending and implementing corrective actions.
• Analyzing clinical output of highly complex studies and providing high level summary with supporting details of study trial status (e.g., Core Lab image perspective) to stakeholders and clinical trial management.
• Identifying, developing, recommending, and leading implementation of complex process development and process improvement solutions to optimize global trial workflow timelines, (e.g., open information requests, aging issues, status of image analysis from Core Labs to study database, etc.).
• Providing guidance and representing department to communicate risk and impact to study core team’s key milestones and deliverables.
• Developing timeline assessment (e.g., clinical site through image transfer vendor to Independent Core Lab) in collaboration with clinical stakeholders in order to meet key study milestones and deadlines.
• Developing training material content in collaboration with clinical stakeholders for clinical sites and clinical field staff.
• Assessing knowledge and/or quality gaps of clinical staff and determining appropriate training plans and/or needs in collaboration with management.

What you’ll need (Required):

• Bachelor’s Degree in related field with 5 years of previous hands‑on clinical research related experience.

What else we look for (Preferred):

• Excellent computer skills in usage of MS Office Suite including Excel and MS Project
• Excellent written and verbal communication skills and interpersonal relationship skills including consultative and relationship management skills
• Excellent problem‑solving and critical thinking skills
• Full understanding and knowledge of principles, theories, and concepts relevant to clinical trial management
• Full knowledge of human anatomy and physiology
• Excellent problem‑solving, organizational, analytical and critical thinking skills
• Good leadership skills and ability to influence change
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast‑paced environment
• Must be able to work in a team environment, including inter‑departmental teams and key contact representing the organization on contracts or projects
• Ability to interact with senior internal and external personnel, inclusive of key opinion leaders (KOL) 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 $92,000 to $130,000 (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.