Centralised Clinical Team Lead
Location: Bangalore
Employment Type: Full Time
Job Overview
The Centralised Clinical Team Lead (CCTL) is responsible for supporting the management and oversight of clinical trial activities under the direction of Project Managers and Clinical Trial Leads. The role focuses on Trip Report review, risk identification, quality oversight, process improvement, issue management, stakeholder communication, and ensuring compliance with ICH-GCP, regulatory requirements, and Fortrea SOPs.
The position acts as a key liaison between Clinical Research Associates (CRAs), Clinical Trial Leads (CTLs), Project Managers (PMs), and study teams to ensure successful clinical trial delivery and patient safety.
Summary of Responsibilities
Clinical Operations Oversight
Support management of complex clinical research projects under the direction of Project Managers and Clinical Trial Leads.
Ensure site monitoring activities are conducted in compliance with:
Fortrea SOPs
ICH-GCP Guidelines
Applicable Regulatory Requirements
Review project progress and implement actions required to achieve study objectives.
Ensure timely communication and collaboration across clinical operations teams.
Act as the primary communication point for Global CTLs and Project Managers.
Trip Report Review & Quality Management
Perform comprehensive review of monitoring Trip Reports for quality, compliance, and consistency.
Ensure Trip Reports align with protocol requirements, GCP standards, and study expectations.
Identify quality concerns, trends, protocol deviations, and operational risks.
Support implementation of best practices related to Trip Report review processes.
Perform quality checks on work completed by newly onboarded CCTL team members.
Ensure consistent and high-quality review standards across projects.
Risk & Issue Management
Proactively identify study risks and operational challenges.
Escalate issues according to project-specific escalation pathways.
Track and follow up on:
Protocol Deviations
Site Issues
Safety Concerns
Monitoring Findings
Operational Risks
Serve as liaison between:
Clinical Research Associates (CRAs)
Clinical Trial Leads (CTLs)
Project Managers (PMs)
Support timely resolution of issues impacting study delivery or patient safety.
Process Improvement & Operational Excellence
Identify opportunities for process improvement within Clinical Operations.
Lead implementation of revised processes, procedures, and operational initiatives.
Support continuous improvement programs to enhance efficiency and quality.
Contribute to development and maintenance of:
Trip Report Templates
Review Guidelines
Departmental Procedures
Best Practice Documentation
Training & Mentorship
Mentor and train newly hired Centralised Clinical Team Leads.
Provide coaching on:
Trip Report Reviews
ICH-GCP Compliance
SOP Adherence
Clinical Operations Processes
Support development of training materials and training plans.
Ensure training resources remain updated with procedural and regulatory changes.
Conduct knowledge-sharing sessions and support team development initiatives.
Clinical Trial Support Activities
Support study teams with:
Clinical Quality Control (CQC) Visits
Document Reviews
eTMF Reconciliation Activities
Protocol Deviation (PD) Review and Trending
PSV/SIV Slide Deck Preparation
CRA Training Activities
CTL Support Tasks
Participate in internal and project-specific initiatives as assigned.
Perform additional duties as assigned by management.
Qualifications (Minimum Required)
Bachelor's Degree in Life Sciences or related discipline preferred.
OR
Certification in an Allied Health Profession such as:
Nursing
Medical Technology
Laboratory Technology
Related Healthcare Disciplines
Equivalent experience may be considered in lieu of educational qualifications.
Experience (Minimum Required)
Minimum 10 years of Clinical Research experience.
Minimum 2 years of Trip Report Review experience.
Strong understanding of:
ICH-GCP Guidelines
Clinical Trial Monitoring
Regulatory Requirements
Clinical Development Processes
Experience supporting global clinical studies.
Strong knowledge of site monitoring activities and clinical operations.
Advanced proficiency in:
Microsoft Word
Microsoft Excel
Microsoft PowerPoint
Demonstrated ability to:
Manage multiple priorities
Lead process improvement initiatives
Influence stakeholders
Mentor and coach team members
Deliver high-quality work consistently
Preferred Skills
Clinical Trial Monitoring
Trip Report Review
Clinical Quality Control
Risk Management
Protocol Deviation Management
eTMF Management
Clinical Operations Leadership
Stakeholder Management
Training and Mentoring
Process Improvement
Inspection Readiness
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