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Clinical Operation Specialist (Cta I - Mumbai, Client Office-Based)

0-2 years
Not Disclosed
10 Nov. 11, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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