Senior Centralized Study Specialist
Company: Fortrea
Job Location: Bangalore, India
Employment Type: Full-Time
Work Model: Hybrid
Job Requisition ID: 263406
Application Deadline: August 31, 2026
Job Overview
The Senior Centralized Study Specialist is responsible for supporting clinical trial contracting, site agreement management, protocol amendments, documentation, and study execution activities across assigned studies.
The role requires strong knowledge of clinical research, ICH-GCP, clinical trial agreements, contract negotiation, amendment management, stakeholder coordination, and study tracking.
The position works closely with Sponsors, Clinical Operations, Regulatory, Legal, Finance, study teams, and clinical sites to ensure contracts and study-related activities are completed accurately, compliantly, and within agreed timelines.
Key Responsibilities
Clinical Trial Contracting
Draft, review, negotiate, and finalize:
Clinical Trial Agreements (CTAs)
Confidentiality Agreements
Contract Amendments
Related Site Contract Documentation
Coordinate with Sponsors, Legal, Clinical Operations, and study teams to facilitate timely contract execution.
Manage site agreement timelines against study milestones.
Ensure contracts are completed within agreed turnaround times.
Maintain accurate contract status and documentation in:
SAMS
UCV
Other applicable systems
Facilitate internal approval workflows.
Obtain required authorizations for contract execution.
Track contract execution status.
Ensure executed agreements are properly filed and maintained.
Identify contracting risks, delays, and issues proactively.
Escalate significant risks and delays to management.
Provide regular status updates to study teams and management.
Protocol Amendment Management
Coordinate protocol amendment submissions for assigned studies and sites.
Manage documentation updates related to protocol amendments.
Support amendment-related:
Contract revisions
Budget revisions
Documentation updates
Review amendment requirements and identify required actions.
Communicate timelines, action items, and documentation requirements to sites and study teams.
Track amendment progress from submission through approval and implementation.
Ensure amendments are completed within required timelines.
Coordinate with Clinical Operations, Regulatory, Legal, and Finance teams.
Site & Stakeholder Management
Communicate with clinical sites regarding contracts and amendment requirements.
Follow up on outstanding site queries and documentation.
Proactively identify issues that could delay study activities.
Maintain effective relationships with internal and external stakeholders.
Coordinate activities across multiple functions and studies.
Provide timely status updates and escalation where required.
Documentation & Compliance
Ensure all contract and amendment documentation is accurately uploaded and maintained.
Maintain study trackers, reports, and operational metrics.
Ensure compliance with:
ICH-GCP
Company SOPs
Sponsor requirements
Quality standards
Applicable regulations
Maintain complete and accurate documentation for audit readiness.
Ensure assigned activities meet quality and compliance requirements.
Study Operations & Process Improvement
Support efficient execution of assigned clinical studies.
Participate in process improvement initiatives.
Identify opportunities to improve contracting and amendment processes.
Support departmental goals and operational objectives.
Complete required:
Training
Timesheets
Compliance activities
Study documentation
Required Skills & Competencies
Strong understanding of clinical trial contracting.
Strong knowledge of protocol amendment processes.
Good understanding of ICH-GCP.
Knowledge of clinical research operations.
Strong contract negotiation skills.
Excellent communication skills.
Strong stakeholder-management abilities.
Strong organizational and multitasking skills.
High attention to detail.
Ability to manage multiple studies simultaneously.
Ability to work effectively under tight timelines.
Experience with contract tracking systems.
Good working knowledge of Microsoft Office.
Minimum Qualifications
University/College degree, preferably in:
Life Sciences
Health Sciences
Related discipline
Allied health certification may also be considered, including:
Nursing
Medical Technology
Laboratory Technology
5–8 years of experience in clinical research.
Strong working knowledge of:
ICH-GCP
Applicable clinical research guidelines
Relevant regulations
Fortrea may consider relevant equivalent professional experience in lieu of educational requirements.
Core Skills
Clinical Research | Clinical Trial Agreements | CTA | Contract Negotiation | Site Contracting | Protocol Amendments | Regulatory Start-Up | ICH-GCP | Clinical Operations | Sponsor Management | Site Management | Stakeholder Management | SAMS | UCV | Contract Tracking | Documentation | Study Trackers | Risk Management | Audit Readiness | SOP Compliance | Process Improvement
Experience – 1-Line Summary
5–8 years of clinical research experience with strong expertise in clinical trial contracting, CTA negotiation, protocol amendments, site management, ICH-GCP, stakeholder coordination, documentation, and study tracking.
Salary Package – Market Estimate
The Fortrea JD does not disclose an official salary range. For a Bangalore-based Senior Clinical Study/Contracting professional with 5–8 years of relevant experience, a reasonable market estimate is approximately ₹9–15 LPA CTC, with candidates having strong CTA negotiation, sponsor-facing, centralized study, and CRO experience potentially targeting ₹12–18 LPA.
Expected market range: ₹9–15 LPA
Strong candidate range: ₹12–18 LPA
Potential higher range: ₹18 LPA+ for highly relevant senior-level clinical contracting/CRO experience.
Note: These are market estimates only and are not an officially confirmed Fortrea salary range.
Work Environment
Hybrid work model.
Bangalore-based position.
Requires regular coordination with internal and external stakeholders.
May involve managing multiple studies and time-sensitive deliverables.
Ideal Candidate Profile
The ideal candidate should have 5–8 years of clinical research experience with significant exposure to Clinical Trial Agreements, contract negotiation, site contracting, protocol amendments, ICH-GCP, sponsor/site communication, study tracking, and cross-functional coordination.
Candidates with experience in a CRO environment, particularly in centralized contracting or study-start-up operations, would be especially well suited for this position.
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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