Clinical Support Specialist II
Company: Syneos Health
Location: Hyderabad, India (Hybrid)
Job ID: 25110263
Updated On: July 3, 2026
Job Summary
Syneos Health is hiring a Clinical Support Specialist II to provide operational and administrative support across various clinical research functions, including Project Management, Site Management, Data Management, Site Activation, Site Contracting, Regulatory Submissions, Biostatistics, and Medical Writing. The role focuses on supporting clinical trial startup activities, maintaining regulatory documentation, and ensuring high-quality project execution in compliance with global clinical research standards.
Key Responsibilities
Provide operational and administrative support to multiple clinical functions.
Support Clinical Research Associates (CRAs) and Country Regulatory Specialists.
Coordinate project documentation and cross-functional communications.
Manage shared mailboxes and organize project files.
Maintain and update clinical and project tracking systems.
Track project timelines and milestones.
Create, compile, format, review, and QC project documents.
Manage document version control and filing.
Coordinate document translations using approved vendors.
Support Trial Master File (TMF) filing and maintain inspection-ready documentation.
Assist with Ethics Committee (Local Package) submissions.
Support Site Activation and Regulatory Submission activities.
Monitor project workload, timelines, and budgeted effort.
Ensure compliance with SOPs, Work Instructions, and GCP guidelines.
Use AI-enabled tools, dashboards, and automated reports for project support.
Complete assigned training and maintain accurate timesheets.
Deliver quality work while collaborating with cross-functional teams.
Required Skills
Clinical Operations
Site Activation
Site Start-Up
Regulatory Submissions
Local Package (Ethics Committee) Submissions
Trial Master File (TMF)
Clinical Documentation
Project Coordination
Timeline & Milestone Tracking
Document Management
Quality Control (QC)
SOP & GCP Compliance
AI-enabled Tools & Dashboards
Microsoft Office (Word, Excel, PowerPoint, Outlook)
Communication Skills
Organizational & Time Management
Problem Solving
Attention to Detail
Eligibility
Associate's Degree or equivalent combination of education, training, and experience.
Experience in Clinical Operations or Clinical Research.
Knowledge of Site Activation, Regulatory Submissions, and Clinical Trial processes.
Experience with Ethics Committee (Local Package) submissions is mandatory.
Good understanding of clinical trial setup, maintenance, and closeout activities.
Strong written and verbal English communication skills.
Experience
Required Experience: 1–2 years of experience in Clinical Operations, Site Activation, Regulatory Submissions, Clinical Trial Start-Up, or Clinical Research Support.
Salary Package (Estimated Market Standard)
₹5.5 LPA – ₹8.5 LPA (depending on experience, relevant skills, and interview performance).
Work Mode
Hybrid
Hyderabad Location
Why Join Syneos Health?
Global exposure to clinical research and drug development projects.
Career growth through structured learning and development programs.
Collaborative and inclusive work culture.
Technical and therapeutic area training.
Employee recognition and rewards programs.
Opportunity to contribute to innovative healthcare and clinical research initiatives.
About Syneos Health
Syneos Health is a leading global life sciences organization that partners with pharmaceutical, biotechnology, and healthcare companies across the drug development and commercialization lifecycle. Over the past five years, the company has contributed to 94% of FDA-approved novel drugs, 95% of EMA-authorized products, and supported 200+ clinical studies across 73,000 sites involving more than 675,000 clinical trial participants.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Delhi | Gangtok | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Auckland |New Zealand :
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Madrid |Cebu Province :
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Manila |Croatia :
Croatia |Zagreb :
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Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
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Japan | Saitama |Tokyo :
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Kyiv |Lima Region :
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