Centralized Study Analyst
Location: Bangalore, India
Work Model: Hybrid
Employment Type: Full-Time
Department: Clinical Operations / Study Start-Up
Experience Required: 3–5 Years
Industry: Clinical Research / CRO / Pharmaceutical / Biotechnology
Position Summary
The Centralized Study Analyst is responsible for supporting clinical trial start-up and site management activities through the coordination of site contracts, protocol amendments, regulatory documentation, and study-related operational processes. The role ensures timely execution of Clinical Trial Agreements (CTAs), management of protocol amendments, and maintenance of study documentation while collaborating with sponsors, sites, legal teams, regulatory functions, and clinical operations teams.
The successful candidate will contribute to efficient study execution by ensuring compliance with applicable regulations, ICH-GCP guidelines, sponsor requirements, and organizational procedures.
Key Responsibilities
Clinical Trial Contract Management
Draft, review, negotiate, and finalize Clinical Trial Agreements (CTAs), confidentiality agreements, amendments, and related site contract documentation.
Coordinate with sponsors, legal departments, clinical operations teams, and study personnel to facilitate timely contract execution.
Manage site agreement timelines and ensure completion within study milestones and established turnaround times.
Facilitate internal contract review and approval processes.
Obtain required authorizations and approvals for agreement execution.
Track contract status and maintain accurate contract records within study management systems.
Ensure executed agreements are properly filed and maintained in designated repositories.
Identify contract-related risks, delays, and operational issues and escalate when necessary.
Provide regular contract status updates and progress reports to stakeholders.
Protocol Amendment Coordination
Coordinate protocol amendment submissions and related documentation updates across assigned studies and sites.
Support amendment-related contract modifications and budget revisions.
Review amendment requirements and communicate timelines, action items, and documentation needs to study teams and investigational sites.
Track amendment progress to ensure timely completion of submissions, approvals, and implementation activities.
Collaborate with Clinical Operations, Regulatory Affairs, Legal, Finance, and external stakeholders to facilitate amendment execution.
Ensure amendment documentation is accurately maintained within study systems and tracking tools.
Support site communication and follow-up activities to resolve outstanding issues and minimize implementation delays.
Study Operations & Compliance
Maintain study trackers, metrics, reports, and operational documentation.
Ensure adherence to Standard Operating Procedures (SOPs), sponsor requirements, quality standards, and ICH-GCP principles.
Support audit and inspection readiness through accurate and complete documentation management.
Monitor study activities and proactively identify operational risks that may impact study deliverables.
Escalate study-related issues and delays to management in a timely manner.
Participate in process improvement initiatives and departmental projects.
Collaborate effectively with internal and external stakeholders to support successful study execution.
Complete required training, compliance activities, and administrative responsibilities within established timelines.
Required Skills & Competencies
Technical Competencies
Strong understanding of clinical trial contracting processes and Clinical Trial Agreements (CTAs).
Knowledge of protocol amendment management and study start-up activities.
Working knowledge of ICH-GCP guidelines and clinical research regulations.
Experience using contract management, study tracking, and clinical trial systems.
Proficiency in Microsoft Office applications, including Excel, Word, Outlook, and PowerPoint.
Professional Competencies
Excellent communication and stakeholder management skills.
Strong negotiation and relationship-building capabilities.
Exceptional organizational and multitasking skills.
Strong analytical and problem-solving abilities.
Ability to manage multiple studies simultaneously in a deadline-driven environment.
High level of attention to detail and quality.
Ability to work independently and collaboratively within cross-functional teams.
Education & Qualifications
Minimum Qualifications
Bachelor's Degree in Life Sciences, Pharmacy, Biotechnology, Nursing, Medical Laboratory Technology, or a related healthcare discipline.
OR
Certification in an allied health profession from an accredited institution.
Equivalent relevant experience may be considered in lieu of educational requirements.
Experience Requirements
Mandatory Experience
3–5 years of experience in Clinical Research, Clinical Operations, Study Start-Up, Site Contracting, Regulatory Affairs, or related functions.
Strong working knowledge of ICH-GCP guidelines and applicable clinical research regulations.
Experience supporting contract negotiation, site agreements, protocol amendments, or clinical trial operational activities.
Preferred Experience
Experience within a CRO, pharmaceutical company, biotechnology organization, or clinical research environment.
Familiarity with contract lifecycle management systems and clinical trial management platforms.
Experience supporting global or multi-site clinical studies.
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Canada |Quebec :
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Greece |North Island :
Auckland |New Zealand :
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Manila |Croatia :
Croatia |Zagreb :
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Japan | Saitama |Tokyo :
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