Job Title: Clinical Operation Specialist (CTA I – Client Office-Based)
Updated: October 24, 2025
Location: Mumbai, India
Job ID: 25102825
Company: Syneos Health®
About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs, and commercial insights into measurable outcomes that address real-world healthcare challenges.
Our Clinical Development model keeps patients and customers at the center of everything we do. We constantly innovate to make processes efficient, ensuring Syneos Health is not only easier to work with — but also easier to work for.
With 29,000 employees across 110 countries, we work together with passion and purpose to change lives.
Motto: Work Here Matters Everywhere.
Why Join Syneos Health
Career advancement through training, mentoring, and leadership support
Inclusive and supportive “Total Self” culture encouraging authenticity and diversity
Opportunities for continuous learning and growth across global functions
Recognition and total rewards program valuing contribution and innovation
Be part of a team that brings diversity of thought and collaboration to life
Position Overview
The Clinical Operation Specialist (CTA I) provides administrative and operational support to clinical research studies (both registrational and non-registrational) from study start-up to closure, working closely with investigative sites and cross-functional teams.
Key Responsibilities
Study Start-Up
Set up vendors and manage operational details during study initiation.
Coordinate importation of study materials (drug and non-drug items such as lab kits, ECGs).
Collect and distribute essential documents from/to sites during the study life cycle.
Obtain insurance certificates for study coverage.
Documentation & Systems Management
Enter and track data in systems like ECLIPSE, eTMF, SAP, and document exchange portals (MyTrials/SIP).
Upload, verify, and maintain completeness of documents within the electronic master file (eTMF).
Prepare and maintain On-Site Investigator Files (ISF) and other study-related binders.
Coordinate translations and printing of study materials (protocols, ICFs, IBs, patient materials).
Financial & Administrative Support
Handle all payment-related activities, including invoice preparation, Payment Due Reports, and PO/fund creation.
Provide administrative support such as mailings, bill processing, printing, and tracking.
Manage archiving processes during study closure.
Regulatory & Compliance Support
Assist with Health Authority (HA) and Ethics Committee (EC) submissions and follow-ups (protocols, IBs, amendments).
Support audit preparation, CAPA development, and inspection readiness activities.
Ensure compliance with GCP, ICH, local regulations, and company SOPs.
Track and support equipment calibration as per study requirements.
Must-Have Qualifications
2–3 years of experience as a Clinical Trial Assistant (CTA).
Basic understanding of GCP, ICH Guidelines, and local regulatory standards.
Familiarity with the drug development process and document flow in clinical trials.
Strong organizational and multitasking skills to meet project timelines.
Ability to work independently with minimal supervision.
Proficient in MS Office and general web-based systems; willing to learn new applications.
Preferred Qualifications
Experience using Clinical Trial Management Systems (CTMS) and eTMF platforms.
Exposure to complex trial-related software (e.g., EDC systems, IVRS/IWRS, patient diaries).
Strong documentation, communication, and cross-functional coordination abilities.
About Clinical Operations
Roles in Clinical Operations ensure the effective execution of clinical research studies while safeguarding participant well-being and data integrity. The team reviews study protocols, plans procedures aligned with regulatory standards, and collaborates across departments to ensure successful trial conduct from start-up to closure.
About Syneos Health – At a Glance
Partnered in 94% of FDA-approved novel drugs and 95% of EMA-authorized products in the past 5 years
Supported 200+ studies across 73,000 sites and 675,000+ patients globally
Dedicated to innovation, compliance, and patient safety in every step of the trial process
Additional Information
This job description reflects the primary duties and qualifications but is not exhaustive. Responsibilities may evolve based on project or organizational needs. Syneos Health is an Equal Opportunity Employer, committed to inclusion and compliance with all applicable laws, including the Americans with Disabilities Act (ADA).
Apply Now
Apply Here – Syneos Health Careers
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