Senior Clinical Operations Specialist / Lead Clinical Operations Specialist (Immediate Joiner)
Company: Syneos Health
Location: IND – Client (Remote/Hybrid depending on assignment)
Job ID: 25108746
Updated On: May 13, 2026
Company Overview
Syneos Health is a global life sciences services organization focused on accelerating drug development and commercialization. It partners with pharmaceutical innovators across the clinical development lifecycle to deliver efficient, compliant, and high-quality clinical research outcomes.
Role Summary
The Senior / Lead Clinical Operations Specialist is responsible for supporting clinical trial execution and operational oversight. The role ensures smooth study conduct through systems management, documentation control, vendor coordination, and clinical study support activities.
Key Responsibilities
1. Clinical Trial Systems Management (CTMS)
Maintain and update Clinical Trial Management System (CTMS) data
Track study timelines, milestones, and regulatory authorizations
Ensure system accuracy and ongoing updates
2. Trial Master File (TMF) Management
Support setup and maintenance of TMF
Ensure all essential documents are properly filed and maintained
Coordinate with clinical teams for continuous TMF updates
Ensure audit readiness of documentation
3. Budget & Financial Tracking
Support Clinical Project Managers in study budget management
Assist in tracking, planning, and reporting of study costs
Perform vendor-related financial reconciliation and reporting
4. External Vendor Coordination
Support onboarding and coordination of external service providers
Ensure documentation and operational readiness of vendors
Monitor vendor activities and follow up on deliverables
5. Study Operations Support
Provide logistical and administrative support for study teams
Assist with study start-up, recruitment, and close-out activities
Coordinate meetings, prepare agendas, and document meeting minutes
Generate reports and support project documentation
6. Central Monitoring & Data Oversight (Advanced Function)
Perform central monitoring using eCRF, IRT, central lab data
Identify trends, deviations, risks, and safety signals
Communicate findings to clinical teams and CRAs
Participate in Data Review Team (DRT) discussions
Support preparation of central monitoring packages
7. Study Start-Up & Close-Out Support
Assist in initiation, recruitment, and study closure activities
Support operational transitions and process implementation
Ensure smooth execution of study milestones
8. Communication & Coordination
Participate in internal and client meetings
Maintain communication with Clinical Trial Teams (CTT)
Escalate issues or risks to project leadership
Ensure alignment across stakeholders
Additional Responsibilities (as required)
Develop monitoring plans and study-specific tools
Provide input into eCRF design and review
Ensure data consistency, completeness, and accuracy across systems
Collaborate with medical teams to identify safety trends
Support CRAs with monitoring preparation and reporting
Required Skills & Experience
7–10 years of Clinical Trial Assistant (CTA) experience
Exposure to centralized monitoring preferred
Strong understanding of clinical trial operations
Experience with CTMS, TMF, and clinical data systems
Strong English communication skills
Proactive, adaptable, and detail-oriented approach
Preferred Competencies
Experience in global clinical trials
Knowledge of GCP and regulatory guidelines
Vendor and stakeholder coordination experience
Ability to manage multiple operational tasks simultaneously
Experience in remote/global team environments
Work Environment
Client-based assignment (India)
Remote/hybrid clinical operations setting
High collaboration with Clinical Project Managers and vendors
Fast-paced, multi-study operational environment
Role Impact
Ensures smooth execution of clinical trials
Maintains regulatory compliance and data integrity
Supports patient safety through monitoring and oversight
Enables efficient study delivery across global trials
Career Progression
This role can lead to:
Clinical Project Manager (CPM)
Clinical Trial Manager (CTM)
Clinical Operations Lead / Associate Director
Central Monitoring / Risk-Based Monitoring Specialist roles
Uttar Pradesh :
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Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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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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Kyiv |Lima Region :
Lima |France :
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Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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