Clinical Operations Associate Analyst

2 weeks ago

Irvine, United States Cypress HCM Full time
Job DescriptionJob Description
Clinical Operations Associate AnalystWe have an exciting opportunity for a Clinical Operations Associate Analyst position with one of the top medical device companies in the country. Responsibilities:
  • Identify, develop, recommend, and implement, moderately complex process development and process improvement solutions to optimize global trial workflow timelines, (e.g., device return aging issues, status of open device issues/queries, etc.)
  • Develop and execute device processes associated with clinical trials. Ensure compliance with regulations and manage the lifecycle of devices, while closely partnering with other internal key stakeholders ( e.g., clinical study teams, Manufacturing Operations, Finance, Supply Chain, Quality, and Compliance groups) to develop and lead the execution of the device process, and ensuring continuous process improvement of efficiency and accuracy of processes and procedures.
  • Verify inventory in JDE and process device shipment to clinical sites within our shipping timeframe to Customer Service, Trade Compliance, and Warehouse. Confirm receipt of product with the clinical site and obtain copies of signed and dated packing slips. Monitor device inventory by coordinating with Supply Chain and Clinical Specialists
  • Develop timeline assessment (e.g., transition to new device system, system enhancements to meet supply and demand, etc) in collaboration with clinical stakeholders in order to meet key study milestones and deadlines.
  • Lead the validation of systems to incorporate the use of clinical system into clinical studies and act as a liaison to ensure adherence to procedures in collaboration with internal (e.g., Study Management) and external (e.g., vendors) stakeholders
  • Ensure documentation are archived appropriately within record retention facility (e.g., Iron Mountain, clinicaltrial.gov)
  • Provide clinical compliance knowledge and determine learning requirements within the learning management system, training plans, study specific training matrices, and study rosters. Analyze and identify internal training deficiencies, as needed.
  • Review and ensure accuracy and completeness of clinical study files, enter into computerized tracking system, and file/scan for archive, for multiple clinical research trials
  • Support clinical research laboratory operations as needed
  • Other incidental duties as assigned.
Skills and Experience:
  • Bachelor's Degree
  • 0-2 years of experience preferred.
  • Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery
  • Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint
  • Good written and verbal communication skills and interpersonal relationship skills
  • Experience with an ERP software, JDE and CTMS (Clinical Trial Management System) preferred
  • Ability to work in a fast paced environment
  • Substantial knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical study documentation
  • Good problem-solving skills
  • Ability to manage confidential information with discretion
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels
  • Adhere to all EHS rules and requirements 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.
Compensation:
  • $28.59 to $38.12 per hour.

  • Clinical Operations Associate Analyst

    1 month ago

    Irvine, United States Cypress HCM Full time

    Job DescriptionJob DescriptionClinical Operations Associate AnalystWe have an exciting opportunity for a Clinical Operations Associate Analyst position with one of the top medical device companies in the country. Responsibilities:Identify, develop, recommend, and implement, moderately complex process development and process improvement solutions to optimize...

  • Clinical Operations Analyst

    4 weeks ago

    Irvine, United States TalentBurst, an Inc 5000 company Full time

    Industry: Medical DevicesPosition: Clinical Operations AnalystJob ID: 6613-1Location: Irvine, CA (On-site)Duration: 12 months contract (+Possibility of extension) Job Description: Summary: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...

  • Clinical Operations Analyst

    2 weeks ago

    Irvine, United States TalentBurst, an Inc 5000 company Full time

    Industry: Medical DevicesPosition: Clinical Operations AnalystJob ID: 6613-1Location: Irvine, CA (On-site)Duration: 12 months contract (+Possibility of extension) Job Description: Summary: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...

  • Clinical Study Operations Associate, Device

    4 days ago

    Irvine, United States Edwards Lifesciences 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...

  • Clinical Study Operations Associate, Device

    4 days ago

    Irvine, United States Edwards Lifesciences 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...

  • Clinical Core Labs Analyst

    2 weeks ago

    Irvine, United States Edwards Lifesciences Corporation Full time

    Imagine how your ideas and expertise can change a patients 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 t Clinical, Operations Analyst, Clinical Research, Analyst, Project Management, Manufacturing, Healthcare,...

  • Clinical Operations Analyst

    4 weeks ago

    Irvine, United States CYNET SYSTEMS Full time

    Job Description: Pay Range $40.31hr - $44.31hr Responsibilities: Analyze clinical output of moderately complex studies and provide a 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...

  • Clinical Contracts Analyst

    2 weeks ago

    Irvine, United States TalentBurst, an Inc 5000 company Full time

    Industry: Medical DevicesPosition: Clinical Contracts AnalystJob ID: 6666-1Location: Irvine, CA (On-site)Duration: 06 months contract (+Possibility of extension)Job Description: Summary:The main function of a clinical contracts analyst is to initiate, draft, redline, and negotiate 3rd party complex contracts based on full knowledge of financial, regulatory...

  • Clinical Contracts Analyst

    4 weeks ago

    Irvine, United States TalentBurst, an Inc 5000 company Full time

    Industry: Medical DevicesPosition: Clinical Contracts AnalystJob ID: 6666-1Location: Irvine, CA (On-site)Duration: 06 months contract (+Possibility of extension)Job Description: Summary:The main function of a clinical contracts analyst is to initiate, draft, redline, and negotiate 3rd party complex contracts based on full knowledge of financial, regulatory...

  • Clinical Contracts Analyst

    4 weeks ago

    Irvine, United States TalentBurst, an Inc 5000 company Full time

    Industry: Medical DevicesPosition: Clinical Contracts AnalystJob ID: 6666-1Location: Irvine, CA (On-site)Duration: 06 months contract (+Possibility of extension)Job Description: Summary:The main function of a clinical contracts analyst is to initiate, draft, redline, and negotiate 3rd party complex contracts based on full knowledge of financial, regulatory...

  • Clinical Trial Contract Analyst

    1 day ago

    Irvine, United States Ledgent Technology Full time

    Medical Device client is seeking a Clinical Contract Analyst for a 6+ mo contract in Irvine, CA (hybrid)!Max Pay - $57.26Must haves for this role:Individuals must be from an enterprise background with companies like J&J, Allergan, Boston Scientific, etc. The team is open to high level CRO's as well.Well versed in the full clinical contract lifecycle...

  • Clinical Study Associate

    6 days ago

    Irvine, United States ICON Clinical Research Full time

    As a Clinical Study Administrator you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. The **Clinical Study Administrator** will assist with processing, tracking, and filing of study documents, and management of the Trial Master File within the clinical projects. Additionally,...

  • Clinical Core Labs Analyst

    2 weeks ago

    Irvine, United States Edwards Lifesciences 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...

  • Clinical Research Coordinator I

    6 days ago

    Irvine, United States Irvine Clinical Research Full time

    Irvine Clinical Research, a research site specializing in clinical trials of Alzheimer's Disease, is seeking applicants for a Clinical Research Coordinator I. The CRC will work under close supervision of our doctors and a research manager as a coordinator on Phase II/III clinical trials in Neurology and Psychiatry.Job DutiesCoordinate the day-to-day clinical...

  • Clinical Core Labs Analyst

    2 weeks ago

    Irvine, United States Edwards Lifesciences Corp 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...

  • Clinical Core Labs Analyst

    2 weeks ago

    Irvine, United States Edwards Lifesciences 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...

  • Associate Clinical Research Specialist

    1 week ago

    Irvine, United States Johnson & Johnson Full time

    Under direct supervision, this Associate Clinical Research Specialist will be responsible for supporting one or several clinical trials and projects within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization. **POSITION DUTIES & RESPONSIBILITIES**: Under direct supervision and in accordance...

  • Sr. Project Analyst

    2 weeks ago

    Irvine, United States APN Software Services Inc Full time

    Job DescriptionJob DescriptionDUTIES:The Sr. Project Analyst Value Management is responsible for supporting the implementation of initiatives that are focused on delivering strategic value to Hoag. Under the guidance of the Vice President or a Project Manager, they will leverage their analytical skills to support metrics development and performance...

  • Senior Project Analyst

    3 days ago

    Irvine, United States eTeam Full time

    Job Title: Senior Project AnalystDuration: 03-06+ Months + High possibility of extensionLocation: Irvine, CA 92618Description:Position Summary:The Sr. Project Analyst – Value Management is responsible for supporting the implementation of initiatives that are focused on delivering strategic value to Hoag.Under the guidance of the Vice President or a Project...

  • Senior Project Analyst

    3 days ago

    Irvine, United States eTeam Full time

    Job Title: Senior Project AnalystDuration: 03-06+ Months + High possibility of extensionLocation: Irvine, CA 92618Description:Position Summary:The Sr. Project Analyst – Value Management is responsible for supporting the implementation of initiatives that are focused on delivering strategic value to Hoag.Under the guidance of the Vice President or a Project...