Centralized Study Analyst
Location: Bangalore
Work Model: Hybrid
Employment Type: Full-Time
Application Deadline: June 30, 2026
Job Requisition ID: 262483
Job Summary
The Centralized Study Analyst supports clinical trial start-up and study execution activities by managing clinical trial agreements, protocol amendments, study documentation, and stakeholder coordination. The role ensures timely contract execution, amendment implementation, regulatory compliance, and maintenance of study records while working closely with sponsors, legal teams, clinical operations, and other cross-functional departments.
The position requires strong organizational skills, knowledge of clinical research processes, and the ability to manage multiple studies and priorities within strict timelines.
Key Responsibilities
Contract Management
Draft, review, negotiate, and finalize:
Clinical Trial Agreements (CTAs)
Confidentiality Agreements (CDAs/NDAs)
Contract Amendments
Related Site Contract Documentation
Coordinate with sponsors, legal teams, clinical operations, and study teams to facilitate timely contract execution.
Manage site agreement timelines and ensure adherence to study milestones and turnaround targets.
Maintain contract documentation and status updates within systems such as SAMS, UCV, and other applicable platforms.
Facilitate internal review and approval workflows for contract execution.
Obtain required authorizations and signatures for agreement finalization.
Track contract progress and ensure executed documents are properly filed and maintained.
Identify contract-related risks, delays, and issues, escalating concerns when necessary.
Provide regular contract status updates to study teams and management.
Protocol Amendment Management
Coordinate protocol amendment submissions for assigned studies and sites.
Support amendment-related contract and budget modifications.
Review amendment requirements and communicate timelines, documentation needs, and action items to study teams and investigative sites.
Track amendment submissions, approvals, and implementation activities.
Collaborate with:
Clinical Operations
Regulatory Affairs
Legal Teams
Finance Departments
Maintain accurate amendment documentation and study records.
Support site communications and follow-up activities to prevent delays in implementation.
Study Operations & Compliance
Ensure compliance with:
SOPs
Sponsor Requirements
Quality Standards
ICH-GCP Guidelines
Maintain study trackers, reports, metrics, and operational documentation.
Monitor study deliverables and escalate risks or delays that may impact timelines.
Support audit and inspection readiness by maintaining complete and accurate records.
Participate in process improvement initiatives and departmental projects.
Collaborate effectively with internal and external stakeholders to support study execution.
Complete required training, compliance activities, and timesheets within established timelines.
Required Skills & Competencies
Clinical Research Knowledge
Strong understanding of:
Clinical Trial Agreements (CTAs)
Protocol Amendment Processes
Clinical Trial Start-Up Activities
Site Contracting Procedures
Working knowledge of:
ICH-GCP Guidelines
Clinical Research Operations
Regulatory Requirements
Technical & Functional Skills
Experience using contract tracking and document management systems.
Proficiency in Microsoft Office Suite:
Excel
Word
PowerPoint
Outlook
Ability to maintain accurate trackers, reports, and study documentation.
Soft Skills
Excellent communication and stakeholder management skills.
Strong negotiation and coordination abilities.
Excellent organizational and multitasking skills.
High attention to detail and accuracy.
Ability to prioritize multiple projects and deadlines.
Strong problem-solving and risk management capabilities.
Educational Qualifications
Minimum Requirements
Bachelor's Degree in Life Sciences (preferred), OR
Certification in an Allied Health Profession from an accredited institution, such as:
Nursing
Medical Technology
Laboratory Technology
Other Healthcare Disciplines
Equivalent relevant experience may be considered in lieu of formal educational qualifications.
Experience Requirements
Required Experience
3–5 years of experience in:
Clinical Research
Clinical Trial Start-Up
Site Contracts
Regulatory Operations
Study Coordination
Clinical Operations
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