- Analyze clinical output of moderately 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 technical and data issues and collaborate with appropriate team members to bring to resolution; Assist in the determination of root cause and recommend and implement corrective actions
- Identify, develop, recommend, and implement moderately 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.)
- Develop basic timeline assessment and/or work with senior level team members on complex 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
- Provide guidance and represent department to communicate risk and impact to study core team's key milestones and deliverables
- Assist in the development of training material content in collaboration with clinical stakeholders for clinical sites and clinical field staff
- Other incidental duties assigned by Leadership
- Bachelor's Degree in related field AND 3 years of previous hands-on clinical research experience
- 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
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Clinical Core Labs Analyst - Irvine, United States - Edwards Lifesciences
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.
As the
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.
How you'll make an impact:
What you'll need (Required):
What else we look for (Preferred):
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 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 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.
