Senior Clinical Study Operations 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.

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.

As the Senior Clinical Operations Analyst for our THV Core Labs team, you will be responsible for providing project management of dynamic and high volume core lab projects across all THV global clinical studies to ensure accurate and timely transfer of images from study sites to Independent Core Labs, and clinical data from Independent Core Labs to Edwards' data management teams to ultimately provide un-biased study results. You will also assist Core Lab Manager to assure sites are set up with adequate and appropriate training resources, site communications, and data security to provide a platform for study success.

The position will be on-site at our Irvine headquarter 4 days/week with 1 WFH day.

How you will make an impact:

• Identify technical and data issues and collaborate with appropriate team members to bring to resolution, determine root cause and recommend and implement corrective actions

• Analyze clinical output of highly complex studies and provide high level summary with supporting details of study trial status (e.g., Core Lab image perspective) to stakeholders and clinical management

• Identify, develop, recommend, and lead 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.)

• Provide guidance and represent department to communicate risk and impact to study core team's key milestones and deliverables

• Field and remote monitoring of studies and data collection for clinical trials with increased volume and complexity (e.g., Core Labs), assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial documentation is within parameters of study protocol, as well as to monitor clinical trial, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements

• Develop timeline assessment (e.g., clinical site through Image workflow vendor to Independent Core Lab) in collaboration with clinical stakeholders in order to meet key study milestones and deadlines

• Develop training material content in collaboration with clinical stakeholders for clinical sites and clinical field staff

• Assess knowledge and/or quality gaps of clinical staff and determine appropriate training plans and/or needs in collaboration with management

What you will need (required):

• Bachelor's Degree in related field AND 5 years of previous hands-on clinical research experience

What else we look for (preferred):

• Project management/operations management experience in the clinical study setting

• Experience working with clinical data

• Advanced Microsoft Excel skills including pivot tables, VLOOKUPS, conditional formatting, importing data, creating graphs/charts, etc.

• Vendor selection and management experience

• Experience from a sponsor

Additional skills:

• Excellent computer skills in usage of MS Office Suite including Excel and MS Project required

• 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

• 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

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 $88,000 to $115,000 (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.