Centralized Study Analyst

Fortrea

0-5 years

Not Disclosed

Bangalore, India

Openings: 10 June 3, 2026

Job Description

Job Type: Full Time Hybrid Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Apache Spark, Artificial Intelligence (AI), Big Data, Data Governance, Data Literacy, Data Management, Data Quality, Data Science, Data Strategies, Data Visualization, Machine Learning (ML), Master Da, Auditing, Audit Management, Audits Compliance, Communication, Continued Learning, Decision Making, Gmp Procedures, Inspection Readiness, Managing Ambiguity, Organizing, People Management and Leadershi, Bachelor’s Degree (BS) or Master’s Degree (MS) in: Life Sciences Pharmacy Biotechnology Biomedical Sciences Chemistry Regulatory Affairs Or related scientific disciplines, Budget Management, Clinical Trials, Negotiation Skills, Process Improvement, Project Planning, Vendor Management, Waterfall Model, Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Intern, Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Intern, Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Intern, Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Intern, Causality Assessment, Change Control, Continual Improvement Process, Data Analytics and Digital, GDP Knowledge, gmp knowledge, HSE Knowledge, Manufacturing Process, Manufacturing Production, Operational Excellence, Process, Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Collaboration, Data Integrity, Decision Making Skills, Lifesciences, Clinical Research, Clinical Trials, Curious Mindset, Databases, Drug Development, Job Description, Lifesciences, Medical Communication, Medical Information, Medical Writing, Military Intelligence, Pat, Clinical SAS Programming, Clinical Trials, Cross-Functional Teams, Drug Development, Lifesciences, Negotiation Skills, People Management, Problem Solving Skills, Regulatory Compliance, Risk Management, Strategy Execution, Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance, Clinical Trials, Functional Teams, Literature Review, Management Skills, Medical Information, Medical Records, Medical Strategy, Pharmacovigilance, Regulatory Compliance, Risk Management, Safety Scien, Coaching Skills, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Pro, Collaboration, Communication Skills, gmp, GMP Guidelines, Operational Excellence, Problem Solving Skills, Quality Agreements, Quality Compliance, Quality Management, Quality Standards, Regulatory Requ, Communication Skills, Continual Improvement Process, Master Data, Material Requirements Planning (Mrp), Materials Management, People Management, Production Planning, Supplier Relationship Management (Srm), Supply-Chain Man, CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, 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, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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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Centralized Study Analyst

Job Description

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