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Centralized Clinical Trial Manager

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ICON
5-10 years
Not Disclosed
Bangalore, Chennai, India
10 Feb. 27, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Centralized Clinical Trial Manager

Job Location: Bangalore or Chennai, India
Work Model: Office-Based or Home-Based
Job Type: Full-Time
Job Requisition ID: JR145001
Industry: Clinical Research / Clinical Trial Management

The Centralized Clinical Trial Manager role is an advanced-level clinical operations position responsible for centralized oversight of clinical trial documentation, visit report quality, protocol compliance, and cross-functional coordination. This position plays a strategic role in ensuring clinical trial delivery aligns with ICH-GCP, regulatory requirements, sponsor expectations, and organizational SOPs.

This opportunity is ideal for experienced clinical research professionals with strong on-site monitoring backgrounds who are ready to transition into centralized trial leadership and quality oversight.

Role Overview

The Centralized Clinical Trial Manager (CCTM) is responsible for reviewing and approving site visit reports in compliance with study protocols, sponsor guidelines, and internal SOPs. The role ensures data accuracy, timely escalation of risks, patient safety oversight, and continuous process improvement across multiple clinical studies.

The CCTM functions as an extension of the Clinical Trial Manager (CTM) team and serves as a key liaison between Clinical Research Associates (CRAs), Project Managers (PMs), and trial stakeholders.

Key Responsibilities

  • Review and approve monitoring visit reports in accordance with protocol, annotated report templates, sponsor SOPs, and corporate standards

  • Ensure high-quality documentation standards with minimized errors and consistent reporting across sites and visits

  • Monitor turnaround timelines for visit reports per contractual and regulatory requirements

  • Track, follow up, and escalate action items and protocol deviations for timely resolution

  • Identify and escalate safety trends observed in monitoring reports to protect patient safety

  • Provide oversight of CTMS, monitoring oversight metrics, and key performance indicators (KPIs) including MVR and follow-up timelines

  • Support continuous improvement initiatives and process optimization across trials

  • Participate in project meetings and contribute insights related to quality trends and operational risks

  • Liaise with CTMs to communicate emerging issues that may impact trial delivery or compliance

  • Ensure inspection readiness and adherence to ICH-GCP and applicable regulatory frameworks

  • Maintain accurate oversight documentation and compliance records

Required Experience

  • Minimum 8–10 years of clinical research experience

  • At least 5 years of hands-on on-site monitoring experience

  • Proven experience in Clinical Trial Management and monitoring oversight

  • Strong understanding of monitoring visit documentation and risk-based monitoring approaches

Educational Qualifications

  • Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Biotechnology, or related healthcare field

  • Advanced degree preferred

Core Competencies and Skills

  • Thorough knowledge of ICH-GCP guidelines and global regulatory requirements

  • Strong analytical and data review capabilities

  • Experience with CTMS platforms and clinical trial oversight systems

  • Excellent organizational and project management skills

  • Ability to manage multiple studies and meet strict deadlines

  • Strong written and verbal communication skills in English

  • Proficiency in Microsoft Office and clinical systems

  • Willingness to travel when required

Why Apply Through ThePharmaDaily.com

ThePharmaDaily.com connects experienced clinical research professionals with global CROs, pharmaceutical sponsors, and biotech organizations. If you have strong monitoring expertise and are looking to step into centralized clinical leadership, this role offers a high-impact opportunity within global clinical development.

Apply now to advance your career in Clinical Trial Management and centralized clinical operations.