Job Details

 

 Job Summary

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  • Job Title: Sr. Associate Central Monitor
  • Job Code: SA-PFE-0085
  • Job Location: Groton, CT 06340
  • Job Date: 11/22/2021
  • Duration: perm
  • First Shift: 08:00 am - 05:00 pm
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 Job Description

SourceAbled is looking for a Sr Associate Central Monitor for a direct hire role for our pharmaceutical client. The position will focus on ensuring the completeness, quality, and integrity of the subject data in the clinical trial database under Risk Based Monitoring (RBM) model.

Candidates with autism, neurodivergence and/or disabilities highly encouraged to apply.

Position Tasks

  • Develop the Risk-Based Monitoring system (i.e. CluePoints) for applicable studies
  • Ensure key risk indicators (KRIs) and data quality assessment (DQA) are properly defined
  • Set up in the system to support the study, processing and reviewing of study data for the signal and action management
  • Follow up for the issue resolution.
  • Review protocols to ensure the set-up, review and reporting requirements can be met and are standardized
  • Provide technical oversight, guidance and coordination for all the central monitor activities
  • Set up and test Risk Based Monitoring (RBM)- Central Monitoring Analytics system at study level to ensure system quality.
  • Work with Study Team to define the issue resolution for the review of findings as signals and actions.
  • Develop, implement, and maintain Quality Control related documentation for RBM related activities to ensure data completeness and accuracy
  • Perform central monitoring activities including review system outputs, propose suggestions for signal and action management, and follow up with study team for the action resolutions.
  • Work with Clinical Data Scientist (CDS) to ensure all signals and actions are properly mitigated and RBM systems properly released
  • Ensure information learned during course of study are documented and shared with other central monitors/study teams to facilitate cross-study learning. Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables. 
  • Review study level system outputs to process for the signal and action management 
  • Plan and execute communication plans & methods to ensure customer satisfaction and enable Able to resolve conflicts, influence and communicate cross-functionally with key stakeholders and customers.

Education/Experience

    • Bachelor's Degree in a scientific or business related discipline.
    • 3+ years’ experience in data management/programming or data mining.
    • Demonstrated knowledge of clinical development including knowledge and understanding of the principles of GCP.
    • Understanding of clinical trials.
    • Awareness of relevant data standards, e.g. CDISC, CDASH, SDTM.
    • Experience with or ability to learn programming in a clinical trial environment, e.g. SAS code, SQL query, R, Python to extract and analyze operational and clinical trial data from various information systems.
    • Ability to critically analyze, interpret, and summarize statistical output from risk-based quality management software, e.g. CluePoints
    • Ability to manage tasks, time and priorities.
    • Demonstrated effective verbal and written communication skills, including the ability to communicate in a remote team environment and adapt communications to audience.

Preferred

    • Relevant pharmaceutical industry experience.
    • Master's Degree
    • Experience with or ability to learn data visualization techniques, e.g. Spotfire, JReview, Tableau.
    • Proficient experience using commercial clinical data management systems and/or EDC products.

To find out more about Rangam, SourceAbled, and this role, click the apply button.  

 

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