Job Title: Clinical Operation Specialist (CTA I – Mumbai, Client Office-Based)
Updated: October 24, 2025
Location: Mumbai, India (Client Site)
Job ID: 25102825
Organization: Syneos Health®
About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization that accelerates customer success by transforming medical, clinical, and commercial insights into real-world outcomes.
With 29,000 employees across 110 countries, Syneos Health brings the customer and patient to the center of every process. The organization’s collaborative and agile approach drives innovation and efficiency in delivering new therapies to market.
Motto: Work Here Matters Everywhere
Why Join Syneos Health
Strong focus on career growth and professional development through mentorship, technical and therapeutic training.
Supportive Total Self Culture fostering authenticity, inclusivity, and employee well-being.
Peer recognition and total rewards program promoting employee engagement and satisfaction.
A diverse, collaborative, and innovative global work environment.
Position Overview
The Clinical Operation Specialist (CTA I) provides administrative and operational support for the setup, execution, and closure of clinical trials.
This role ensures smooth coordination among study sites, vendors, and internal teams, with responsibility for document management, submissions, payment tracking, and study logistics.
Key Responsibilities
1. Study Start-Up Support
Manage administrative and operational activities related to registrational and non-registrational clinical trials (including Investigator Sponsored Research Studies).
Set up vendors and collect operational details from study sites.
Coordinate and manage importation of study drugs and non-drug supplies (e.g., lab kits, ECG equipment).
Prepare and organize On-site Investigator Files and other essential documentation.
Support equipment calibration tracking and study initiation activities.
2. Documentation & Systems Management
Enter and maintain data in internal systems including ECLIPSE, eTMF, and SAP.
Ensure timely upload, quality control, and completeness checks of documents in electronic Trial Master File (eTMF) and other platforms (e.g., MyTrials, Shared Investigator Portal).
Coordinate translation, printing, and binding of study-related documents such as protocols, ICFs, and Investigator Brochures.
Manage archiving activities at study closure as per company standards.
3. Financial & Administrative Coordination
Handle invoice processing, payment tracking, and preparation of Payment Due Reports, fund requests, and Purchase Orders (POs).
Manage insurance certificate procurement for study sites.
Provide administrative support to the study team, including mailing, billing, and documentation tasks.
4. Regulatory & Ethics Support
Support Local Global Regulatory Submissions (GRS) by preparing and/or performing submissions to Health Authorities and Ethics Committees for approvals and amendments.
Follow up on submission status until approvals are received.
Assist during audits, inspections, and Corrective and Preventive Action (CAPA) preparations for local issues.
Qualifications & Experience
Must Have
2–3 years of experience as a Clinical Trial Assistant (CTA).
Basic understanding of ICH-GCP guidelines, local regulations, and drug development processes.
Ability to manage multiple priorities and meet project deadlines.
Demonstrated ability to work independently with minimal supervision.
Strong computer aptitude and willingness to learn new systems.
Preferred
Experience with Clinical Trial Management Systems (CTMS) and eTMF systems.
Exposure to other clinical research applications such as Electronic Data Capture (EDC), Patient Diaries, and Interactive Voice/Web Response Systems (IVRS/IWRS).
Core Skills
Excellent organizational, documentation, and time management skills.
Strong communication and interpersonal abilities.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and general web-based tools.
Attention to detail and ability to handle high-volume documentation accurately.
Team-oriented mindset with a proactive and solution-driven approach.
About Syneos Health’s Global Impact
Over the past 5 years, Syneos Health has:
Partnered on 94% of all FDA-approved novel drugs and 95% of EMA-authorized products.
Conducted over 200 studies across 73,000 sites and 675,000+ trial patients worldwide.
At Syneos Health, every role contributes to advancing clinical research and improving patient lives.
Website: www.syneoshealth.com
Additional Information
Responsibilities listed are not exhaustive and may vary based on business needs.
Equivalent education and experience will be considered.
Syneos Health is an equal opportunity employer and complies with disability and diversity regulations globally.
Reasonable accommodations are available for employees or applicants as needed.
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