Senior Analyst, Clinical Operations

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

Benefits offered by this job

Competitive salary

Performance-based incentives

Benefits programs

Job summary

Edwards Lifesciences, located in Irvine, CA, is seeking a Clinical Affairs professional to enhance evidence generation and optimize patient outcomes through data-driven strategies and collaboration with investigators, clinicians and regulators.

The role focuses on clinical trial oversight, data analysis, and process improvements, with a strong emphasis on cross-functional teamwork and delivery against study milestones.

Qualifications

• Bachelor’s Degree in related field with 5 years of hands-on clinical research experience.
• Strong MS Office Suite and communication skills, including written and verbal.
• Knowledge of clinical trial management principles and processes.

Responsibilities

• Identify technical and data issues and collaborate to resolve them; determine root cause and implement corrective actions.
• Analyze clinical output of complex studies and summarize trial status for stakeholders.
• Lead process development to optimize global trial workflows and information transfer.

Skills

Clinical research

Data analysis

Root cause analysis

Project management

MS Office

Education

Bachelor’s degree

Tools

MS Project

Job description

USA - California – Irvine

Full time

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.

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.