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

2-3 years

Not Disclosed

India

10 Oct. 28, 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

🌍 Job Title: Clinical Operation Specialist (CTA I – Client Office-Based)

🏢 Company: Syneos Health®

📍 Location: Mumbai, India (Client Office-Based)

🆔 Job ID: 25102825

🗓️ Updated On: October 24, 2025

🔬 About Syneos Health

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization designed to accelerate customer success.
With over 29,000 employees across 110 countries, we bring clinical, medical, and commercial expertise together to deliver results faster — because work here matters everywhere.

Our mission: To place patients and customers at the center of everything we do — simplifying, streamlining, and accelerating clinical development.

🌐 Learn more: www.syneoshealth.com

💼 Position Overview

As a Clinical Operation Specialist (CTA I), you’ll manage the administrative and business activities supporting clinical trial operations — from study start-up to study closure.
This includes maintaining document flow, supporting regulatory submissions, coordinating vendors, and ensuring smooth execution of study processes in compliance with ICH-GCP and local regulatory standards.

🎯 Key Responsibilities

📁 Study Administration

Manage administrative and business activities related to registrational and investigator-sponsored studies.
Set up vendors during study start-up and collect operational details from sites.
Enter and track data in systems such as ECLIPSE, eTMF, SAP, and other clinical platforms.
Upload, complete, and quality-check documents in document exchange portals (MyTrials, Shared Investigator Portal).
Coordinate translation, printing, and distribution of study-related materials (protocols, ICFs, IBs, patient materials).
Maintain On-Site Investigator Files and handle archiving at study closure.

📦 Logistics & Operations

Arrange importation of drug and non-drug supplies (e.g., lab kits, ECGs) to study sites.
Track and support equipment calibration and documentation.
Obtain and manage insurance certificates for trial activities.

💰 Financial Activities

Prepare and process invoices, payment due reports, fund requests, and POs.
Ensure payment accuracy and timely financial follow-up with stakeholders.

🧾 Regulatory & Compliance Support

Support Local GRS with Health Authority submissions and follow-up for approvals.
Assist in Ethics Committee submissions (protocols, IBs, amendments).
Support audit preparation, inspection readiness, and CAPA documentation.

🧠 Must-Have Qualifications

2–3 years of experience as a Clinical Trial Assistant (CTA).
Basic understanding of ICH-GCP guidelines and local regulatory frameworks.
Familiarity with the drug development process and document flow in clinical trials.
Proven ability to manage multiple priorities and meet deadlines.
Strong independent work ethic and attention to detail.
General proficiency with software systems, databases, and web-based applications.

💡 Preferred Qualifications

Hands-on experience with CTMS (Clinical Trial Management Systems) and eTMF platforms.
Familiarity with EDC, IVRS, and eDiary systems.
Prior experience coordinating multi-site studies or vendor management.

🌟 Why Join Syneos Health

At Syneos Health, you’ll be part of a culture that values authenticity, growth, and belonging.
We believe in developing people through:

🌱 Career development & progression
🤝 Supportive and engaged leadership
🧠 Technical and therapeutic area training
🏆 Recognition and rewards programs

We’re committed to our Total Self culture — empowering employees to bring their true selves to work and thrive in a diverse, inclusive environment.

📊 Impact & Contribution

As part of the Clinical Operations team, you’ll:

Ensure safe and compliant conduct of clinical studies.
Collaborate across functions to monitor study progress, address issues, and uphold quality standards.
Support the development of study materials, communication with sites, and regulatory alignment.

Your work ensures patient safety, data integrity, and operational excellence across global clinical research.

⚖️ Equal Opportunity Statement

Syneos Health is committed to fostering a diverse and inclusive workplace.
We welcome applicants from all backgrounds — even if your experience doesn’t perfectly align with the role.
We also encourage you to join our Talent Network to stay informed about future opportunities.

🚀 Join Us

Be part of the team that’s helping develop 94% of FDA-approved novel drugs and 95% of EMA-authorized products over the past five years.
At Syneos Health, every role contributes to a single goal: improving lives through science.

🔗 Apply Now | or join our Talent Network to stay connected.

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

Job Description

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