Clinical Operation Specialist (CTA I) – Mumbai (Client Office-Based)
Company: Syneos Health
Updated: 24-Oct-2025
Location: Mumbai, India
Job ID: 25102825
About Syneos Health
Syneos Health is a leading fully integrated biopharmaceutical solutions organization.
They focus on accelerating clinical, medical, and commercial outcomes through innovation, collaboration, and a strong patient-centric model.
29,000 employees across 110 countries
Worked on 94% of FDA-approved drugs in last 5 years
Worked on 95% of EMA-authorized products
Supported 200+ studies across 73,000 sites and 6.75 lakh patients
Position Summary
The Clinical Operation Specialist (CTA I) provides administrative, documentation, and operational support throughout the lifecycle of clinical trials (start-up → conduct → closure).
Role focuses on document management, regulatory support, vendor coordination, site support, and system tracking.
Must-Have Requirements
2–3 years experience as a Clinical Trial Assistant (CTA)
Basic understanding of ICH-GCP and local regulations
Basic knowledge of clinical trial process & document flow
Ability to manage multiple tasks & meet deadlines
Ability to work independently
Strong computer aptitude; ability to learn new software systems
Preferred Skills
Experience using:
CTMS (Clinical Trial Management Systems)
eTMF (Electronic Trial Master File)
Familiarity with tools such as:
Electronic Data Capture (EDC)
Patient diaries
Interactive Voice/Web Response (IVRS/IWRS)
Key Responsibilities
✅ 1. Study Start-Up Activities
Set up vendors and collect site operational details
Coordinate translation of:
Protocol
Informed Consent Form (ICF)
Patient materials
Arrange importation of:
Study drug
Lab kits
ECG machines
✅ 2. Documentation Management
Upload, manage, and complete documents in:
ECLIPSE
eTMF
SAP
MyTrials / Shared Investigator Portal
Perform completeness checks
Prepare On-Site Investigator File
Handle documentation for printing, binding, and archiving
✅ 3. System Tracking & Data Entry
Enter required data into all relevant study systems
Track study progress, documents, payments, and materials
✅ 4. Financial Activities
Prepare invoices
Generate payment due reports
Create fund requests / Purchase Orders (POs)
✅ 5. Regulatory & Ethics Support (May Include)
Submission to:
Health Authorities
Ethics Committees
Preparation and follow-up on:
Protocols
Amendments
IB
Support during:
Audits
CAPA preparation
Inspections
✅ 6. Study Conduct & Closure
Collect/distribute site documents
Support equipment calibration and tracking
Handle archiving processes at study end
General Role Description
Provides administrative and operational support in clinical research
Ensures patient safety and protocol adherence
Coordinates with cross-functional teams
Communicates with sites and manages essential documents
Work is routine but requires accuracy and independence
Ideal Candidate Profile
Strong attention to detail
Good documentation & coordination skills
Organized and proactive
Comfortable with multiple clinical trial systems
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