Centralised Clinical Team Lead I
Location: Bangalore, India
Category: Clinical / Clinical Operations
Employment Type: Full-Time
Experience Required: 8+ years in Clinical Research, including 2+ years in Trip Report Review
Job Overview
We are seeking a Centralised Clinical Team Lead I to manage clinical projects and ensure the successful execution of clinical trials in compliance with Fortrea Standard Operating Procedures (SOPs), ICH-GCP guidelines, and local regulatory requirements. The role involves overseeing site monitoring, mentoring Clinical Research Associates (CRAs), supporting clinical trial deliverables, and driving process improvement initiatives. This position reports to the Project Manager or Project Director and requires strong leadership, operational, and clinical expertise.
Key Responsibilities
Lead and manage clinical projects under the guidance of the Project Manager/Director, ensuring timely and compliant execution.
Oversee site monitoring responsibilities, ensuring adherence to SOPs, ICH guidelines, and GCP standards.
Implement trip report review best practices, including review of templates, guidelines, and project-specific plans.
Identify and escalate risks, protocol deviations, and operational issues, serving as a liaison between CRAs, CTLs, and Project Managers for timely resolution.
Proactively propose and support process improvement initiatives within clinical operations.
Maintain up-to-date training and ensure the team’s compliance with changes in procedures, SOPs, and Work Instructions.
Support clinical teams during CQC visits for local and regional clinical trial sites.
Train, mentor, and guide CRAs and IHCRAs across clinical operations functions.
Perform additional responsibilities as assigned, including document review, ETMF reconciliation, PD review and trending, PSV/SIV slide deck creation, and CRA training support.
Ensure effective communication of project progress, outstanding issues, safety concerns, and operational trends to relevant stakeholders.
Required Qualifications & Experience
Education: University or college degree in Life Sciences or a related allied health profession (e.g., Nursing, Medical Technology, Laboratory Technology).
Experience: Minimum 8 years in clinical research with a strong understanding of ICH-GCP guidelines and applicable regulatory requirements.
At least 2 years of trip report review experience is highly desirable. Candidates with 8+ years of relevant clinical research experience in pharmaceutical or CRA industries will also be considered.
Demonstrated ability to plan, organize, and communicate effectively across project teams.
Proficiency in MS Office Suite (Word, Excel, PowerPoint) and departmental clinical tools.
Strong interpersonal skills with the ability to influence, lead, and facilitate meetings.
Experience in process improvement initiatives, mentoring, and delivering high-quality clinical operations output.
Work Environment & Physical Demands
Primarily office-based in Bangalore, India; remote work possible based on business needs.
Candidates should be flexible to work shifts and extended hours if required.
May involve extensive computer usage and domestic travel for site monitoring and project support.
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