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Centralized Clinical Trial Manager

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ICON
8-10 years
Not Disclosed
Bangalore, Chennai, India
2 May 7, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology

Centralized Clinical Trial Manager

Location: Bangalore, India / Chennai, India
Work Mode: Office or Home (Hybrid/Flexible)
Job Type: Full-Time
Experience Required: Minimum 8–10 Years in Clinical Research with 5+ Years in On-Site Monitoring
Industry: Clinical Research / Pharmaceutical / CRO


Job Overview

We are seeking an experienced and highly organized Centralized Clinical Trial Manager to oversee centralized clinical trial operations, site visit report reviews, protocol compliance activities, and quality oversight across global clinical studies. The selected candidate will act as an extension of the Clinical Trial Management (CTM) team, ensuring high-quality monitoring documentation, timely issue resolution, and adherence to regulatory and sponsor standards.

This role is ideal for professionals with strong expertise in clinical trial management, on-site monitoring, protocol deviation management, clinical quality review, and stakeholder coordination within pharmaceutical, biotechnology, or CRO environments.


Key Responsibilities

Clinical Trial Oversight & Report Review

  • Review and approve:
    • Site visit reports
    • Monitoring visit reports (MVR)
    • Follow-up letters (FUL)
    • Clinical monitoring documentation
  • Ensure reports comply with:
    • Study protocols
    • Sponsor SOPs
    • ICON SOPs
    • Regulatory guidelines
  • Maintain high standards of:
    • Data accuracy
    • Documentation quality
    • Consistency across sites and visits
  • Minimize report errors and ensure timely report completion.

Protocol Deviation & Action Item Management

  • Follow up on:
    • Action items
    • Protocol deviations
    • Escalation activities
    • Quality concerns
  • Coordinate with:
    • Clinical Research Associates (CRA)
    • Clinical Trial Managers (CTM)
    • Project Managers (PM)
      for timely issue resolution.
  • Escalate unresolved issues, operational risks, and patient safety concerns appropriately.

Clinical Quality & Safety Oversight

  • Monitor and escalate:
    • Safety trends
    • Patient-related concerns
    • Operational inconsistencies
    • Compliance risks
      identified in visit reports.
  • Ensure adherence to:
    • ICH-GCP guidelines
    • Clinical trial regulations
    • Sponsor quality standards
    • Internal compliance procedures.

Operational Management & Metrics Tracking

  • Perform regular oversight of:
    • OMR systems
    • ICO Trial platforms
    • Sponsor CTMS systems
    • Vendor systems
  • Track and ensure compliance with:
    • Timelines
    • Quality metrics
    • Monitoring deliverables
    • Action item closure
  • Support process optimization and continuous improvement initiatives within clinical trial operations.

Cross-Functional Collaboration

  • Liaise with:
    • CTMs
    • CRAs
    • Clinical Operations teams
    • Sponsors
    • Vendors
    • Cross-functional stakeholders
  • Participate in project meetings and provide recommendations for:
    • Quality improvement
    • Operational efficiency
    • Monitoring consistency
    • Clinical trial performance
  • Communicate safety concerns and operational risks that may impact study delivery or patient safety.

Training & Continuous Improvement

  • Complete all required training programs related to:
    • Clinical research
    • Quality standards
    • Process management
    • Regulatory compliance
  • Promote a culture of:
    • Continuous improvement
    • Process optimization
    • Operational excellence
    • Service quality enhancement.

Required Qualifications

Educational Qualifications

Required Qualification:

  • Bachelor’s Degree in:
    • Life Sciences
    • Healthcare
    • Pharmacy
    • Biotechnology
    • Clinical Research
    • Nursing
    • Or related scientific disciplines

Preferred Qualification

  • Advanced Degree preferred in:
    • Clinical Research
    • Life Sciences
    • Healthcare Management
    • Pharmaceutical Sciences