Centralized Study Analyst
Location: Bangalore
Category: Clinical
Job ID: 262483
Role Overview
The Centralized Study Analyst supports clinical study operations with a strong focus on clinical trial agreements, protocol amendments, and study-level coordination activities. The role ensures timely execution of contracts and amendments while maintaining compliance with ICH-GCP guidelines, sponsor requirements, and internal SOPs.
This position requires strong coordination across cross-functional teams to ensure smooth study execution and high-quality documentation management.
Key Responsibilities
1. Clinical Trial Agreements (CTA) & Contract Management
Draft, review, negotiate, and finalize:
Clinical Trial Agreements (CTAs)
Confidentiality agreements (CDAs)
Amendments and site contract documentation
Coordinate with:
Sponsors
Legal teams
Clinical Operations
Study teams
Ensure timely execution of contracts within study milestones and timelines.
Maintain contract status in systems such as SAMS, UCV, and other tracking tools.
Track and manage contract execution lifecycle from initiation to filing.
2. Site & Study Coordination
Ensure smooth coordination between study sites and internal teams.
Communicate contract progress, updates, and outstanding issues.
Maintain accurate records of executed documents in repositories.
Support resolution of site-related queries and delays.
3. Internal Approvals & Workflow Management
Facilitate internal approval workflows for contract execution.
Ensure required authorizations are obtained on time.
Maintain compliance with SOPs and internal governance processes.
4. Protocol Amendment Support
Coordinate protocol amendment submissions and updates.
Review amendment requirements and communicate action items.
Support contract and budget updates aligned with protocol changes.
Track amendment timelines and ensure timely completion and implementation.
5. Cross-Functional Collaboration
Work closely with:
Clinical Operations
Regulatory Affairs
Legal teams
Finance teams
Ensure alignment across all stakeholders for smooth study execution.
6. Documentation & Tracking
Maintain accurate study trackers, reports, and dashboards.
Ensure all amendment-related documents are properly uploaded and maintained.
Monitor contract and amendment progress across studies.
7. Risk Management & Escalation
Identify risks, delays, and operational issues impacting study timelines.
Escalate critical issues to management proactively.
Support mitigation planning and resolution tracking.
8. Compliance & Quality Assurance
Ensure adherence to:
SOPs
ICH-GCP guidelines
Sponsor requirements
Quality standards
Support audit readiness through complete and accurate documentation.
9. Process Improvement
Participate in continuous improvement initiatives.
Support efficiency improvements in contract and amendment processes.
Contribute to departmental goals and operational enhancements.
10. Administrative Responsibilities
Complete assigned training and compliance activities on time.
Maintain timesheets and required documentation.
Support operational reporting and documentation needs.
Required Skills & Competencies
Strong knowledge of clinical trial contracting processes
Understanding of protocol amendments and clinical study operations
Knowledge of ICH-GCP guidelines
Strong communication and stakeholder management skills
Excellent organizational and multitasking abilities
High attention to detail and accuracy
Ability to manage multiple priorities under tight timelines
Proficiency in:
Contract tracking systems
Microsoft Office tools
Qualifications
Education
University/College degree in Life Sciences preferred
OR
Certification in allied health fields (e.g., Nursing, Medical Technology, Laboratory Technology)
Experience Requirements
3–5 years of experience in clinical research
Strong understanding of ICH-GCP and clinical regulations
0–2 years of additional professional experience in related roles
Key Competencies
Strong organizational and communication skills
Ability to work collaboratively in cross-functional teams
High-quality and consistent work delivery
Strong computer and system usage skills
Work Environment
General office-based environment
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