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Cental Monitoring Specialist

Fortrea
Fortrea
3-5 years
Not Disclosed
Bangalore, India
10 April 22, 2026
Job Description
Job Type: Full Time Education: B.Pharm. or Post-Graduation (Microbiology/Quality Assurance/Biochemistry/Biotechnology) Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing

Job Title:

Central Monitoring Specialist


Job Overview:

The Central Monitoring Specialist is responsible for executing central monitoring activities at the site, subject, and study level. The role involves collaborating with study teams, reviewing data from informatics platforms, identifying risks, and ensuring timely reporting and resolution of issues. The specialist plays a key role in risk assessment, monitoring strategy, and data-driven decision-making throughout the study lifecycle.


Key Responsibilities:

Central Monitoring & Study Execution:

  • Perform central monitoring activities across multiple studies and portfolios
  • Ensure accurate tracking and status reporting of assigned studies
  • Conduct reviews at country, study, site, and subject level
  • Ensure timely completion of monitoring activities and reporting

Risk Assessment & Management:

  • Support and prepare study risk assessments
  • Review risk indicators (RIs) and identify potential risks
  • Recommend mitigation strategies and changes in risk profile
  • Conduct deep-dive analysis of site and subject-level risks
  • Propose changes to monitoring intervention levels

Reporting & Documentation:

  • Create, review, and compare monthly risk/status reports
  • Prepare and distribute:
    • Quality risk reports
    • Project/study reports
  • Upload reports to e-TMF, Veeva Vault, or central repositories
  • Maintain and update Central Monitoring Plans and Configuration Plans

Collaboration & Coordination:

  • Work closely with study teams and stakeholders
  • Organize and participate in Study Risk Assessment meetings
  • Take meeting minutes and maintain risk assessment tools
  • Follow up on:
    • Site findings
    • Query resolutions
    • Administrative issues
  • Act as backup for team leads

Data Analysis & Informatics:

  • Review data from informatics platforms (EDC, lab data, etc.)
  • Support development of data visualization and platform requirements
  • Perform study analytics reviews and communicate insights
  • Provide data-driven recommendations to stakeholders

System & Process Support:

  • Perform User Acceptance Testing (UAT) and write test scripts
  • Populate and manage tools with risk factors and monitoring parameters
  • Adjust trigger levels and study-specific risk settings
  • Suggest improvements for processes, tools, and systems

Additional Contributions:

  • Identify study scope changes and evolving risks
  • Contribute ideas for process improvement and innovation
  • Support business growth by promoting central monitoring solutions

Qualifications (Minimum Required):

  • Bachelor’s degree (preferably in Life Sciences) from a recognized institution
  • Equivalent relevant experience may be considered

Experience (Minimum Required):

  • 3–5 years of clinical research experience in:
    • Pharmaceutical companies
    • CROs (Contract Research Organizations)
    • Or related clinical trial roles such as:
      • Project Management
      • Clinical Monitoring
      • Data Management
      • Informatics

Skills & Competencies:

  • Strong analytical and problem-solving skills
  • Attention to detail and accuracy
  • Good planning, time management, and organizational skills
  • Effective communication and teamwork abilities
  • Basic influencing and negotiation skills
  • Understanding of project and risk management

Preferred Qualifications:

  • Postgraduate degree in Life Sciences or related field
  • Additional relevant certifications or experience

Work Environment:

  • Standard office or remote (home-based) working setup