Clinical Research Senior Systems Administrator Job at TD2, Scottsdale, AZ

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  • TD2
  • Scottsdale, AZ

Job Description

Description:s for RFIs and proposals; also assist with the development and presentation of slides for client presentations (e.g. bid defense and kick-off meetings).
  • Maintain a folder of trial CTMS documents and training certificates for inclusion in the Trial Master File (TMF).
  • Continually grow personal skill level on CTMS and TMF systems.
  • Lead integration with Electronic Data Capture systems by partnering with the Data Management team to Independently prepare and manage weekly external EDC ingestions with Cyberduck raw data files inputs, configure internal EDC tagging, and perform external EDC clinical trial Ingestion User Acceptance Testing (UAT).
  • Assist users in obtaining department metric reports as outputs from the CTMS system.
  • Assist with Clinical activities, as needed, such as maintaining TD2 Controlled Documents within the Learning Management System (LMS).
  • Perform other duties as assigned.

Job Requirements:

  • Bachelor’s degree is required, preferably in a health science field.
  • 2+ years of clinical research experience (CRA, CTM, PM, or other clinical research-related role) within a CRO is highly preferred.
  • Minimum five (5) years’ experience working in CTMS and TMF systems as clinical program manager.
  • Knowledge in pharmaceutical drug development with experience in oncology as a therapeutic area is preferred.

Required Specialized/Technical Skills:

  • Knowledge of GCP, ICH guidelines and FDA regulations.
  • Experience with CTMS, including acting as CTMS Administrator.
  • Experience with eTMF, including acting as eTMF Administrator.
  • Strong working knowledge of computer programs including CTMS, eTMF, and MS Office products including Word, Excel, and PowerPoint.
  • Prior experience with clinical research with an understanding of clinical operations including clinical trial design, study implementation, CRA/site management, and data management.
  • Excellent planning, organizational and time management skills, including the ability to support and prioritize multiple projects.
  • Advanced communication and problem-solving skills.
  • Able to work under tight timelines.
  • Ability to lead internal and external meetings with appropriate meeting note taking and follow- through of action items.

TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veteran’s status, gender, sexual orientation, gender identity, or gender expression.

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Job Tags

Full time,

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