Job Title: Centralised Clinical Team Lead II
Location: Bangalore, India
Category: Clinical
Job ID: 25382
Company: Fortrea
Employment Type: Full-time
Seniority Level: Mid-to-Senior (Individual Contributor)
Position Summary
As a Centralised Clinical Team Lead II (cCTL-II) at Fortrea, you will lead centralized clinical monitoring and trip report review activities across multiple studies. This role involves cross-functional collaboration with Clinical Research Associates (CRAs), Project Managers (PMs), and global stakeholders, ensuring quality and compliance in clinical trial monitoring per ICH-GCP and SOPs.
Key Responsibilities
Trip Report Review & Monitoring Oversight
Review CRA trip reports and identify risk trends and protocol deviations.
Mentor and train CRAs and centralized team members on reporting best practices.
Own and update trip report templates, guidelines, and support eTMF reconciliation.
Act as liaison between CRA, CTL, and PM to resolve issues efficiently.
Prepare PSV/SIV slide decks and support document reviews and trending analyses.
Central Monitoring Leadership
Lead central monitoring activities for multiple studies.
Design, implement, and refine study-specific risk assessment and mitigation strategies.
Develop Central Monitoring Plans, configuration documents, and oversee analytics.
Perform study-level and site-level data reviews; propose monitoring level adjustments.
Manage and analyze key performance indicators via visual data tools and reports.
Maintain updated risk profiles and ensure quality reporting is completed on time.
Project & Quality Oversight
Support study teams during sponsor audits, quality events, and CQC visits.
Ensure compliance with SOPs, regulatory requirements, and issue escalation processes.
Suggest and support continuous process and systems improvements.
Prepare for regulatory inspections and assist in inspection readiness activities.
Training & Mentorship
Provide onboarding and ongoing training for junior cCTLs.
Collaborate in the development of SOPs and training materials.
Qualifications & Skills
Bachelor’s degree or equivalent in life sciences or a health-related field.
Several years of clinical research experience, including centralized monitoring.
Strong knowledge of ICH-GCP, regulatory compliance, and clinical trial processes.
Experience in data-driven decision-making and using data visualization tools.
Excellent written and verbal communication skills.
Ability to work independently and collaboratively in a cross-functional environment.
About Fortrea
Fortrea is a leading global contract research organization (CRO) dedicated to supporting clinical trial operations, patient safety, and regulatory compliance across the life sciences sector.
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