IrvineRecruiter
the smart solution for Irvine jobs

Associate Manager, Clinical Trial Master File / Clinical Operations

Company: Edwards Lifesciences
Location: Irvine
Posted on: January 14, 2019

Job Description:

Edwards Lifesciences has a unique opportunity to play a critical role in Transcatheter Mitral & Tricuspid Therapies (TMTT) clinical study execution. Internally titled as the Associate Manager of Clinical Operations - the Trial Master File Manager will lead the team responsible for eTMF, study training matrices and study supplies while maintaining and driving high levels of accuracy and compliance in a fast-paced, complex environment.
The ideal candidate will be a dynamic leader and team player who has successfully managed a team responsible for the eTMF in a cardiovascular / medical device organization.
Depending on experience level, we are open to hiring Clinical Trial Master File (TMF) at the Associate Manager or Manager level.
This role is based in Irvine, California
Essential Job Functions:

  • Lead team responsible for all aspects of the eTMF (electronic trial master file) including accuracy, completeness and compliance of documentation in multiple clinical research trials.
  • Lead team in development, maintenance and management of internal study training matrices and tracking of respective training records.
  • Lead team with production, distribution and tracking of study materials (e.g. study binders and patient recruitment materials) to clinical sites
  • Work with cross functional partners to create and communicate detailed metrics reporting (e.g. eTMF and internal study training completion) to drive study compliance.
  • Lead projects from inception through completion, including developing and/or scheduling key milestones, securing and allocating resources.
  • Develop multiple competing timeline assessments, identify and resolve risks that deviate from plan, and collaborate with clinical stakeholders in order to meet key study milestones and deadlines.
  • Assess knowledge and/or quality gaps of staff and determine appropriate training plans and/or needs.
  • Mentor, coach, and train team members.#LI-MO1
    #MI
    Required Education/Skills/Experience:
    • Bachelor's Degree in related field.
    • 8 years of related experience in Clinical Trials required. 10 years required for Manager level.
    • Strong People Management Skills with the ability to lead and manage a diverse team with successful experience supervising subordinates.
    • Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), Veeva eTMF (electronic Trial Master file)
    • Travel up to 10> Preferred:
      • Industry experience with Class II & III medical devices preferred.
      • Experience obtained from sponsor run studies in Med Device, CRO and Pharma industriesAdditional Talents and General Expectations:
        • Proven detailed project management experience with demonstrated ability to influence change.
        • Demonstrated strong problem-solving, process improvement, analytical, and collaborative skills.
        • Comprehensive written and verbal communication, facilitation, presentation and follow-up skills.
        • Meticulous organizational skills and the ability to meet tight deadlines in an environment of competing priorities.
        • Extensive knowledge of international regulations of Good Clinical Practice (GCP)
        • Extensive knowledge and understanding of diverse and applicable regulations and standards relevant to medical devices (e.g., 21 CFR Part 11/50/54/56/801/803/806/807/820/812/814/821/822, ISO 14155; ICH GCPs)
        • Extensive knowledge of clinical trials and regulatory requirements
        • Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization.

          Keywords: Edwards Lifesciences, Irvine , Associate Manager, Clinical Trial Master File / Clinical Operations, Healthcare , Irvine, California

          Click here to apply!

          Didn't find what you're looking for? Search again!

          I'm looking for
          in category
          within


Other Healthcare Jobs


Travel Nurse RN - ICU Intensive Care Unit
Description: Nationwide Travel Nurse Jobs - Intensive Care Unit RNAre you looking for a new nursing job Would you like to spend the season somewhere you've never been Hospitals nationwide are looking for qualified (more...)
Company: Travel HealthCare Jobs
Location: Perris
Posted on: 01/22/2019

Licensed Vocational Nurse (Yorba Linda,CA)
Description: Licensed Vocational Nurse Yorba Linda,CA Centra Healthcare Solutions is seeking an experienced Licensed Vocational Nurse that is licensed or in the immediate process, and qualifies, of obtaining LVN (more...)
Company: Centra Healthcare Solutions
Location: Yorba Linda
Posted on: 01/22/2019

Physician: 100% Outpatient Neurology Opportunity with No Call in South
Description: Fantastic opportunity to be an employed General Neurologist or Movement Disorder, Epilepsy, Neuromuscular specialist within a successful hospital in Southern California. This opportunity is 100 outpatient (more...)
Company: CompHealth
Location: Palm Springs
Posted on: 01/22/2019


Licensed Vocational Nurse (Yorba Linda,CA)
Description: Centra Healthcare Solutions is seeking an experienced Licensed Vocational Nurse that is licensed or in the immediate process, and qualifies, of obtaining LVN licensure in CA to work in SNF / LTC in the (more...)
Company: Centra Healthcare Solutions
Location: Yorba Linda
Posted on: 01/22/2019

Employed Gastroenterology Opportunity in Orange County, CA (Physician
Description: Tenet Healthcare is actively seeking a Gastroenterologist for a full-time opportunity in Orange County, CA. The practice is located in Yorba Linda, CA and
Company: Tenet Healthcare
Location: Yorba Linda
Posted on: 01/22/2019

Clinical Coding
Description: We are a fast-growing tech company that provides a SaaS-based healthcare analytics platform for medical records analysis and targeted solutions for HEDIS Hybrid, Medicare and Exchange Risk Adjustment (more...)
Company: Mommy Jobs Online
Location: Yucaipa
Posted on: 01/22/2019

Travel Nurse RN - MICU Medical Intensive Care
Description: Nationwide Travel Nurse Jobs - Medical Intensive Care RNAre you looking for a new nursing job Would you like to spend the season somewhere you've never been Hospitals nationwide are looking for qualified (more...)
Company: Travel HealthCare Jobs
Location: Apple Valley
Posted on: 01/22/2019

Southern California General Surgery Opportunity (Physician #482423)
Description: Join a practicing surgeon in La Quinta, California, located in Southern California's beautiful Coachella Valley. Existing surgeon relocated to La Quinta and started his own solo practice just 1 -- years (more...)
Company: Tenet Healthcare
Location: La Quinta
Posted on: 01/22/2019

Licensed Therapist / Physical Therapist Job in San Clemente, California
Description: This unique opportunity is at a prestigious facility looking to hire a traveling therapist. This exciting area offers
Company: Host Healthcare
Location: San Clemente
Posted on: 01/22/2019

Nurse Practitioner - Urgent Care - PRN Coverage (Nurse Practitioner #)
Description: Urgent Care opening in Apple Valley, California. Family Nurse Practitioner needed to cover PRN shifts in San Bernardo
Company: Medical Doctor Associates
Location: Apple Valley
Posted on: 01/22/2019

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Irvine RSS job feeds