IrvineRecruiter Since 2001
the smart solution for Irvine jobs

Manager, Clinical Data Management

Company: JenaValve Technology, Inc.
Location: Irvine
Posted on: February 22, 2021

Job Description:

JenaValve is currently looking for a Manager, Clinical Data Management to contribute to the overall conduct and timely execution of JenaValve clinical trials by overseeing clinical database (design & validate, maintain and shutdown EDC) for clinical trials and overseeing data quality related appropriate clinical databases, and participating in the review and analysis of clinical data. This person will ensure the quality and integrity of data collected in clinical studies, the privacy of patient data and efficient recording and reporting of safety related issues. -- Responsibilities :

  • Oversee, manage, and participate in the development of clinical database design for JenaValve clinical studies, including User Acceptance Testing (UAT), query logic and language, edit checks, roles, and permissions and CRF completion guidelines and requirements as needed for specific databases.
  • Collaborate with the Director of Medical Affairs and other teams like Clinical Operations and Clinical Project Management team to develop Data Management Plans for study protocols, Data Surveillance Plans (as applicable) for clinical studies.
  • Develop EDC training materials and documentation.
  • Participate in data analysis with Clinical Project Management and statistical experts and consultants.
  • Manage timelines and milestones associated with database design, data review and database locks/freezes.
  • Oversee the overall quality of data and identifies key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns to key deliverables.
  • Work closely with the Clinical Project Management team, including study managers, clinical field monitors to ensure quality of clinical data through appropriate data collection and review.
  • Develop and manage data management quality documentation including Department Standard Operating Procedures (DSOPs) and Work Instructions (WIs) as needed.
  • Prepare and support vendor and agency audits as assigned.
  • Hire and manage clinical data team members as needed. Required Education and Experience :
    • 8+ years of experience in clinical data management is required (preferred in medical devices).
    • Technical skills in clinical databases and reporting tools (e.g. iMedidata, Medidata Rave, Oracle EDC) is preferred.
    • B.S. or B.A. in biological or medical/clinical sciences preferred with 5 years functioning as a lead data manager. Advanced degree is preferred.
    • Working knowledge of GCPs and regulatory requirements related to clinical research.
    • Working knowledge of data management practices.
    • Strong organization skills and time management in a dynamic environment; ability to work on multiple projects.
    • Good critical thinking and sound communication skills.
    • Self-motivated and detailed oriented. Skills and Abilities Required for This Job :
      • Knowledge of GCPs governing the conduct of clinical trials; working knowledge of Medical Device regulations and ICH Guidelines.
      • Experience working with all phases of study conduct: start-up, maintenance, and closeout.
      • Experience with PMA submissions and Clinical Trial Data Audits.
      • Experience writing SOPs and work instructions.
      • Must have ability to work collaboratively as part of a multi-functional medical device development team in a dynamic environment.
      • Excellent oral and written communication skills; excellent interpersonal skills, including the ability to influence and to work effectively cross-culturally and cross-functionally.
      • Ability to work in a fast-paced work environment within a cross-functional and highly interdependent team structure.

Keywords: JenaValve Technology, Inc., Irvine , Manager, Clinical Data Management, Healthcare , Irvine, California

Click here to apply!

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

I'm looking for
in category

Other Healthcare Jobs

RN, Critical Care Specialties - HealthCare Traveler
Description: Critical Need for All Hospital Based RN SpecialtiesTravel Registered Nurse Jobs Assignments br Looking for an RN travel assignment You are in the right place, the HCEN Network of staffing agencies (more...)
Company: HealthCare Traveler Jobs
Location: Lake Elsinore
Posted on: 03/5/2021

PRN - Registered Nurse (RN) - ICU
Description: Job Description We have immediate per diem PRN shifts available
Company: Aya - Shifts
Location: Poway
Posted on: 03/5/2021

Surgery Department - Special Procedures Travel RN
Description: Travel Surgery Nurses Needed - Special Procedures RNs Nationwide Travel RN Nursing Assignments br br Looking for a Surgical Services travel assignment You are in the right place, the HCEN Network (more...)
Company: RN Travel HealthCare Jobs
Location: Yucaipa
Posted on: 03/5/2021

School Speech Language Pathologist - 321181892
Description: We're looking for an exceptional School Speech Language Pathologist for a full-time position in La Mesa, CA who can start immediately and work through December 18th. This therapist will help with the (more...)
Company: The Job Network
Location: La Mesa
Posted on: 03/5/2021

Travel Cytotechnologists
Description: Travel Cytotechnologist Numerous Nationwide Travel Assignments / Jobs br br Tired of completing an application just to get informationClick the View or Apply button for HCEN's Free, Quick Short (more...)
Company: HealthCare Traveler (Allied Health)
Location: Rosemead
Posted on: 03/5/2021

Medical Surgical RN Travel Nurse Assignments - Med Surg
Description: Medical Surgical RN - Nationwide Travel Nurse Assignments Are 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: HealthCare Traveler Jobs
Location: La Mirada
Posted on: 03/5/2021

RN - Rehab - Crisis Response
Description: Host Healthcare has a great travel nurse opportunity. A prestigious facility is looking to hire a travel nurse. This is an opportunity to earn top pay while
Company: Host Healthcare
Location: Poway
Posted on: 03/5/2021

Licensed Therapist / Speech Language Pathologist / California / Speech Language Pathologist Job
Description: Speech Language Pathologist Positions Available Now - Lake Elsinore, CA The Stepping Stones Group is currently interviewing Speech Language Pathologists like YOU for the 2020-2021 school year and ESY (more...)
Company: The Stepping Stones Group
Location: Lake Elsinore
Posted on: 03/5/2021

Licensed Massage Therapist
Description: Los Angeles, CA SHARE YOUR HEALING TOUCH WITH--LOS ANGELES Join the Number 1 rated on-demand massage service in the world Soothe connects massage therapists directly to clients via our app, making the (more...)
Company: Soothe
Location: San Gabriel
Posted on: 03/5/2021

PCU Progressive Care Unit RN-Travel Nurse
Description: Travel Nurse Progressive Care RN Registered Nurse br PCU Travel Nurse Jobs Assignments br Looking for a PCU travel assignment You are in the right place, the HCEN Network of staffing agencies have (more...)
Company: RN Travel HealthCare Jobs
Location: La Mirada
Posted on: 03/5/2021

Log In or Create An Account

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

Irvine RSS job feeds