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Centralised Clinical Team Lead Ii

0-2 years
Not Disclosed
10 May 1, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.