About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success by combining clinical, medical affairs, and commercial expertise.
Key Highlights
29,000+ employees across 110 countries
Strong track record supporting:
94% of novel FDA-approved drugs
95% of EMA-authorized products
Global clinical trial footprint across thousands of sites and patients
Work Culture
“Work Here Matters Everywhere” philosophy
Emphasis on career growth, training, and development
Inclusive Total Self culture promoting authenticity and belonging
Strong focus on diversity, collaboration, and innovation
Role Overview
Position: Clinical Trial Manager I / II (CTM I / CTM II)
Location: India (Remote – Client-based)
Job Type: Talent Pipeline / Future Opportunity
The CTM is responsible for leading clinical trial operations, ensuring delivery of site management, clinical monitoring, and central monitoring activities. This role focuses on patient safety, regulatory compliance, data integrity, and timely execution of clinical studies.
Key Responsibilities
1. Clinical Trial Oversight
Lead site management, clinical monitoring, and central monitoring activities
Oversee study execution from site activation to closeout
Ensure compliance with:
Protocol
ICH-GCP guidelines
Regulatory requirements
2. Risk Management & Strategy
Identify critical data, processes, and execution risks
Contribute to Risk Assessment and Categorization Tool (RACT)
Develop and implement risk mitigation strategies
Escalate risks related to timeline, quality, and budget
3. Study Planning & Execution
Review study scope, protocol, and budgets
Ensure team alignment with contractual obligations
Participate in key meetings (e.g., Kick-Off Meetings)
Drive study milestones:
Site activation
Patient enrollment
Database lock
4. Team Leadership & Oversight
Manage CRAs and Central Monitors
Oversee:
Resource allocation
Site assignments
Team performance and compliance
Provide feedback to line managers on team performance
5. Cross-Functional Collaboration
Work with:
Study Start-Up teams
Data Management
Patient Recruitment
Pharmacovigilance
Quality Assurance
Ensure seamless coordination and delivery across functions
6. Systems & Tools Management
Oversee setup and use of:
CTMS (Clinical Trial Management System)
EDC (Electronic Data Capture)
ePRO / eDiary systems
TMF (Trial Master File)
Ensure dashboards and systems reflect real-time study progress
Support User Acceptance Testing (UAT)
7. Monitoring Quality & Compliance
Review:
Monitoring visit reports
Site communications
Central monitoring reports
Ensure documentation reflects:
Site performance
Compliance risks
Patient safety concerns
8. Training & Development
Train study teams on:
Protocol specifics
CRF completion
SOPs and clinical plans
Ensure ongoing compliance with study requirements
9. Client & Stakeholder Interaction
Provide updates on study progress, risks, and deliverables
Act as escalation point for site-related issues
Communicate with investigators and site staff when needed
10. Audit & Inspection Readiness
Support inspection readiness activities
Ensure compliance with:
SOPs
Regulatory standards
Monitoring plans
Qualifications
Education
Bachelor’s degree or Registered Nurse (RN) in a related field
Equivalent experience may be considered
Experience
Minimum 2+ years of CTM experience
Experience in:
Clinical trial site management
Clinical monitoring
Vendor management experience (preferred)
Experience with risk-based monitoring (preferred)
Technical Knowledge
Good Clinical Practice (GCP)
ICH Guidelines
Clinical trial processes and systems
Budget and financial management basics
Skills & Competencies
Strong leadership and team alignment skills
Strategic thinking and problem-solving ability
Strong communication and interpersonal skills
Conflict resolution skills
Ability to manage complex, global clinical trials
Critical thinking and risk-based decision-making
Travel Requirements
Moderate travel (~20%)
Role Summary
The CTM I / II acts as a clinical functional lead, responsible for:
Managing clinical and central monitoring teams
Ensuring compliance with monitoring plans
Delivering studies on time, within budget, and with high quality
Supporting clinical operations through leadership, mentoring, and technical expertise
Additional Information
This is a pipeline opportunity, not an active role
Responsibilities may evolve based on business needs
Equivalent qualifications and experience will be considered
Company complies with global employment regulations and provides reasonable accommodations
Call to Action
Apply or join the Talent Network to be considered for future opportunities
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
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Mexico |northeastern :
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Saarbrucken |Switzerland :
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Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
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Queensland |Melbourne :
South Yarra |United Kingdom :
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Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Mississauga | Uxbridge | Renfrew | Richmond Hill | North York | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |Greece :
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Auckland |New Zealand :
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Barcelona |Madrid :
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Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Kyiv |Lima Region :
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Taipei |Mazovia :
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