Senior Clinical Operations Specialist / Lead Clinical Operations Specialist
Company: Syneos Health
Location: IND – Remote
Job ID: 25108746
Updated On: May 13, 2026
Company Overview
Syneos Health is a global life sciences organization that supports clinical development, regulatory operations, and drug commercialization. The company works across the full clinical trial lifecycle to accelerate the delivery of new therapies.
Role Summary
The Senior / Lead Clinical Operations Specialist is responsible for:
Supporting clinical trial operations and study execution
Managing clinical trial systems, documentation, and study workflows
Supporting Clinical Project Managers in study planning and execution
Ensuring compliance, data accuracy, and operational efficiency across clinical trials
Key Responsibilities
1. Clinical Trial Systems & Data Management
Maintain and update Clinical Trial Management Systems (CTMS)
Update study timelines, milestones, and regulatory approvals
Ensure accurate tracking of study progress in systems
2. Trial Master File (TMF) Management
Support setup and maintenance of TMF (Trial Master File)
Ensure completeness, accuracy, and proper filing of essential documents
Coordinate with clinical teams for continuous TMF updates
3. Budget & Financial Support
Assist Clinical Project Managers with study budget tracking
Support planning, reporting, and reconciliation of study costs
Perform good receipt booking aligned with vendor financial reports
4. External Service Provider Coordination
Support setup and coordination of external vendors and service providers
Ensure required documentation and onboarding materials are complete
Monitor day-to-day vendor operations and follow-ups
5. Study Operations Support
Provide logistical and administrative support for study teams
Assist with study start-up, recruitment, and close-out activities
Support meeting scheduling, coordination, and documentation (minutes, reports)
6. Central Monitoring & Data Oversight (Advanced Responsibility)
Conduct central monitoring using eCRF, IRT, and lab data
Identify trends, safety signals, protocol deviations, and data issues
Communicate findings to CRAs and clinical teams for resolution
Support Data Review Team (DRT) discussions
7. Study Documentation & Reporting
Prepare monitoring plans and study-specific tools (if required)
Review eCRFs and study-related documentation
Generate reports from clinical systems
8. Communication & Stakeholder Management
Participate in internal and external meetings
Maintain communication with clinical trial teams and vendors
Escalate critical issues to project leadership
Required Experience & Skills
7–10 years of Clinical Trial Assistant (CTA) experience
Exposure to centralized monitoring preferred
Strong understanding of clinical research operations
Experience with CTMS, TMF, and eCRF systems
Good communication skills in English
Proactive, detail-oriented, and quick learner
Preferred Competencies
Experience in clinical trial start-up, conduct, and close-out
Knowledge of vendor management in clinical studies
Familiarity with regulatory compliance and GCP guidelines
Ability to work independently in remote environments
Work Environment
Fully remote (India-based)
Global clinical operations setting
High collaboration with Clinical Project Managers and vendors
Fast-paced, deadline-driven clinical trial environment
Role Impact
Ensures smooth execution of clinical trials
Maintains compliance and data integrity across study systems
Supports patient safety and operational efficiency
Contributes to successful study delivery and regulatory readiness
Career Progression
This role can lead to:
Clinical Project Manager (CPM)
Clinical Operations Lead / Manager
Clinical Trial Manager (CTM)
Central Monitoring / Risk-Based Monitoring Lead roles
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Remote, India | Siliguri |Illinois :
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Tallinn |Hà Nội :
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Bangkok |Israel :
Tel Aviv | Yavne | Kfar Saba | Netanya | Be'Er Sheva |Remote :
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Prague |Chile :
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