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Centralized Monitor

2 years years
Preffered by Company
Not Disclosed May 14, 2024
Job Description
Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Opportunity at IQVIA: Centralized Monitor - India

Position: Centralized Monitor
Location: Ahmedabad, Gujarat
Domain: Clinical Operations

Job Overview:
The Centralized Monitor is responsible for managing the execution of assigned clinical studies from initiation to closeout. This includes ensuring that all project deliverables meet the timelines and adhere to standard operating procedures (SOPs), policies, and practices. The role involves providing project-related support across multiple projects, sites, and teams, reviewing structured clinical data outputs, and ensuring adherence to all relevant SOPs, policies, Good Clinical Practices, and regulatory requirements. The monitor is also responsible for ensuring patient safety, data integrity, and protocol compliance while managing site visit reports and maintaining high standards of quality.

Essential Functions:

  • Independently manage assigned sites and perform Subject Level Data Review; perform dual roles if required.
  • Conduct remote monitoring visits as assigned.
  • Investigate clinical data at the site level to ensure accuracy and completeness of patient information for reviews.
  • Engage in study-specific analytics and contribute to developing new analytics proposals as per customer demand.
  • Provide operational insights on assigned sites/studies, manage study/site metrics, and ensure compliance with clinical operation plans.
  • Offer guidance and input to clinical study teams and stakeholders to facilitate continuous process improvements and issue resolution.

Qualifications:

  • Bachelor's degree in clinical, life sciences, mathematical sciences, related field, or nursing.
  • At least 2 years of relevant experience or an equivalent combination of education, training, and experience.

This role ensures the smooth execution of clinical trials with a focus on quality and efficacy, supporting IQVIA's commitment to enhancing healthcare outcomes.