Edwards Lifesciences

Analyst, Clinical Operations

Edwards Lifesciences

1 Edwards Way, Irvine, CA 92614, USA
Full-TimeDepends on ExperienceMid-LevelBachelors
Job Description

As the Analyst, Clinical Operations, you will support the execution of internal device processes associated with clinical trials. Ensure compliance to global processes and regulations. Provide guidance on timely and accurate shipment initiation, investigational device inventory, and returns according to regulatory and company guidelines. Continuous process improvement of efficiency and accuracy of processes and procedures. Provide support of device accountability process within electronic database for internal team members (e.g., clinical specialist and field monitors). Develop basic timeline assessment and/or work with senior level team members on complex timeline assessment (e.g., transition to new device system, system enhancements, etc.) in collaboration with clinical stakeholders in order to meet key study milestones and deadlines. Assist management in making changes in SOPs, Work Instructions and IFUs in Ignite system to support all Clinical projects. Provide guidance and represent department to communicate risk and impact to study core team's key milestones and deliverables

Where is this job?
This job is located at 1 Edwards Way, Irvine, CA 92614, USA
Job Qualifications
  • Minimum 3 years of experience related to supporting clinical trial management/operations

  • Experience with Clinical Systems (such as CTMS, JDE, TMF, SQMS)

  • Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects

  • Ability to build productive internal/external working relationships

Required Skills
  • MS Word

  • Salesforce

  • Time Management Skills

  • MS Excel skills

  • Device Accountability

  • Clinical trial management

Soft Skills
  • Detail Oriented

  • Prioritizing skills

  • flexibility

  • Organizational skills

  • Verbal and Written Communication

  • Driven for excellence

Compensation

According to JobzMall, the average salary range for a Analyst, Clinical Operations in 1 Edwards Way, Irvine, CA 92614, USA is between $93,958 and $109,000.

Additional Information
Edwards Lifesciences is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedAugust 2nd, 2021
Apply BeforeMay 22nd, 2025
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About Edwards Lifesciences

Edwards Lifesciences (NYSE: EW) is the global leader in the science of heart valves and hemodynamic monitoring.

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