PaloAltoRecruiter Since 2001
the smart solution for Palo Alto jobs

Medical Specialist

Company: Genesis10
Location: Palo Alto
Posted on: November 22, 2021

Job Description:

Genesis10 is currently seeking a Medical Specialist with our client in the SEO industry in their Palo Alto location. This is a 12 month + contract position. Description:

  • The Sr. Clinical Data Manager (CDM) is responsible for managing data management (DM) activities in the design, administration, data collection and locking of databases for clinical trials and studies.
  • As part of the Clinical Research Team, the CDM will play a key role in the clinical team and interface with external CROs and external vendors to fulfill many of his/her responsibilities. Responsibilities:
    • Serve as the Data Manager on multiple studies
    • Develop database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations.
    • Create and maintain project DM documentations (Data Management Plan, etc)
    • Develop Case Report Form (CRF), electronic and/or paper.
    • Participates in the review of Clinical research documents (eg. Protocols, Case Report Forms, Reports and Statistical analysis).
    • Extract and monitor the trial data to identify issues
    • Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock
    • data reconciliation and/or Manage CDM activities with clinical trial monitors
    • Participates in the preparation and presentation of data, when applicable.
    • Ensures data system compliance by following the established guidelines of national and international regulatory authorities.
    • The Sr. Clinical Data Manager (CDM) is responsible for managing data management (DM) activities in the design, administration, data collection for clinical trials and studies.
    • As part of the Clinical Research Team, the CDM will play a key role in the clinical team to fulfill many of his/her responsibilities.
    • Work with various product area teams to guide them on data collection and proper documentation
    • Develop CRF, DMP and program EDC and provide hands on support for database programming Qualifications:
      • Minimum of 2 years of experience in Clinical Data Management from CROs or Medical Device/Pharmaceutical companies.
      • Experience in electronic data capture (EDC) systems.
      • Working knowledge of ICH/GCP guidelines, Clinical Research, Clinical Trial process and FDA regulations. Working knowledge of Clinical Database applications such as EDC and CTMS. Knowledge of industry data standards (CDISC, SDTM, CDASH).
      • Excellent organizational skills.
      • Outstanding interpersonal, oral and written communication skills.
      • Able to work as a W2 employee of Genesis10 (no Corp-to-Corp) Desired:
        • BS preferably in Health Sciences, Statistics, MIS or Informatics.
        • Applicable knowledge working with other clinical databases, SAS, and other.
        • Experience with working on device registries within the medical device and/or pharmaceutical industry.
        • A programming background is nice to have (software or EDC). If you have the described qualifications and are interested in this exciting opportunity, apply today! About Genesis10: Genesis10 is a leading U.S. business and technology consulting firm with hundreds of clients needing proven talent and solutions to power their strategic initiatives. If you are a high performing business or IT professional with solid, referenced experience, we want to meet you. Genesis10 recruiters and delivery professionals are highly accomplished career advocates, who get to know you beyond your resume to position you with the opportunities that fit your skills, experience and aspirations. We have benefit options to fit your needs and a support staff that works with you from placement throughout your engagement project after project. To learn more about Genesis10 and to view all our available career opportunities, please visit us at www.genesis10.com "Genesis10 is an Equal Opportunity Employer, M/F/D/V

Keywords: Genesis10, Palo Alto , Medical Specialist, Healthcare , Palo Alto, California

Click here to apply!

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

I'm looking for
in category
within


Log In or Create An Account

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

Palo Alto RSS job feeds