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.
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Tallinn |Hà Nội :
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