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Clinical Monitoring Analyst (Cluepoints) - Remote
Clinical Monitoring Analyst (Cluepoints) - RemoteIQVIA • WorkFromHome, Free State, South Africa
Clinical Monitoring Analyst (Cluepoints) - Remote

Clinical Monitoring Analyst (Cluepoints) - Remote

IQVIA • WorkFromHome, Free State, South Africa
5 days ago
Job type
  • Remote
Job description

Clinical Monitoring Analyst (Cluepoints) - Remote

IQVIA, Bloemfontein, Free State, South Africa

This unique role within IQVIA lends itself to a Lead programmer on Cluepoints called Centralized Monitoring Analyst (CMA) with strong communication and organisation skills. Having experience with SAS programming is necessary. The CMA contributes to the execution of the Centralized Monitoring process by performing setup, programming and refresh(es) of the Centralized Monitoring platform, according to the study‑specific Centralized Monitoring Plan (CMP). This role is part of a sponsor‑dedicated project where you will be working with the client directly to manage deliveries.

Responsibilities

  • Supports the Centralized Monitoring Lead (CML) in the development of the fit‑for‑purpose CM strategy by contributing to the identification of the relevant CM elements to be implemented for the study (Quality Tolerance Limits (QTL), Key Risk Indicators, data visualizations and Data Quality Assessments)
  • Setup / Program QTL, KRI and Data Quality Assessments according to the study CMP
  • Refresh the Centralized Monitoring Platform at predefined frequency to enable signal identification
  • Generate and maintain the Centralized Monitoring Platform specifications document and file it in eTMF
  • Review and understand protocol
  • Understand the data sources for the study, the data transfer specifications and the data structure
  • Execute and document peer‑review of CM platform setup done by other CMA colleagues

Experience & Qualifications

  • At least 3 years relevant experience in the area of pharmaceutical research and development or related field, preferably in centralized Monitoring, data management, and / or biostatistics
  • 2-3 years SAS experience including macro language
  • Knowledge / experience working on Cluepoints
  • Ability to work in an autonomous way and engage with relevant stakeholders to execute activities related to study‑level centralized monitoring process
  • Ability to understand basic statistical analysis concepts and to interpret their outcome
  • Ability to maintain confidentiality of data and information during interactions with staff at all levels
  • Ability to work with limited close supervision
  • Demonstrated communication, interpersonal, organizational, and problem‑solving skills
  • High levels of initiative, drive and commitment
  • Prior experience in a Data Management related field is required
  • Experience with relational databases, preferably Clinical Data Management and EDC Systems
  • Experience communicating with all levels of personnel and participating in collaborative work teams (locally and globally)
  • Advanced knowledge of federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices
  • Excellent command, both verbal and written, of English
  • This role is not eligible for UK visa sponsorship.

    IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

    Additional Information

  • Seniority level : Not Applicable
  • Employment type : Full‑time
  • Job function : Research, Analyst, and Information Technology
  • Industry : Pharmaceutical Manufacturing
  • #J-18808-Ljbffr

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    Analyst Monitoring • WorkFromHome, Free State, South Africa

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