- Design, create, validate, and modify clinical databases, and tools and programs for data validation checks, and clinical trial reporting
- Lead cross functional teams in the design and delivery of moderately complex functional modules and provide data management expertise regarding clinical trials, protocols, and case report forms
- Establish the development of specifications for systems and/or processes, system upgrades and enhancements; and engage IT to deliver higher level support to users
- Develop and present training to end-users, including providing guidance to lower level Clinical Programmers in their training program development. End-users include, but not limited to, clinical study project teams, external clinical study users, junior-level Clinical Programmers, etc., as well as resolving escalated customer/user issues
- Establish the development of SOPs, company standards, and test scripts, and verify software specifications and system configurations to ensure the quality, compatibility, compliance of clinical systems, including working with external system vendors and service providers for clinical trials
- Oversee the documentation of clinical database structures, specifications, reports and other database-related tasks during the life of a clinical trial to ensure data quality and compliance with regulatory guidelines and company SOPs
- Write processes, SOPs, user guides, and other user support documentation for general data management functions
- Bachelor's Degree
- A minimum of 4 years' experience related experience in clinical research, data management, software programming or related field
- Ability to travel 2-3 times/year to headquarters
- Medidata Rave with custom function experience
- Expert understanding of clinical programming procedures while addressing issues with impact beyond own team based on knowledge of related disciplines
- Expert understanding of related aspects of clinical programming processes and/or systems
- Support system integrations with Medidata and/or outside of Medidata
- Experience with CDISC and CDASH
- Familiarity with data lake concepts
- Experience working in Medrio or Veeva EDC
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Senior Analyst, Clinical Programming, Critical Care - Irvine, United States - Edwards Lifesciences
Description
For over 50 years, the Critical Care business within Edwards Lifesciences (NYSE:
EW) has operated at the intersection of groundbreaking medical innovation and improved patient care.
Put simply, we exist because we're committed to creating a world where every patient who _should_ be monitored _will_ be monitored with smart technology.
With this impactful vision in mind, we are now embarking on becoming an independent business from Edwards, a process that we currently expect to be completed by January 2025.
As Critical Care transitions to an independent company, we will continue to benefit from the expertise and experience of 4,000+ dedicated global employees, a vibrant innovation engine with strong investment in our future pipeline, and strong sales growth and profitability.
So, if you're a dynamic and passionate person who is eager to contribute to an innovative, industry-leading advanced monitoring company we invite you to explore our career opportunities.
Those who choose to join us will be part of a 'once-in-a-lifetime' journey to improve the quality of care and outcomes for millions of patients around the world.
_Appendix:
_
For further detail on the spin-off of Critical Care from Edwards Lifesciences, please consult this 2023 Investor Conference Presentation, pages
How you will make an impact:
What you will 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 accepted while this position is posted on our Career 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.
