Job Title: Senior Clinical Trial Assistant (Sr. CTA) / CTA III / Senior Clinical Operations Specialist
Company: Syneos Health
Location: India (Remote)
Job Type: Full-Time
Experience Required: 3–6 Years of Experience in Clinical Research, Clinical Operations, or Pharmaceutical Industry
About Syneos Health
Syneos Health is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. The company combines clinical development, medical affairs, and commercial expertise to help pharmaceutical and biotechnology organizations bring innovative therapies to market faster.
With a workforce of more than 29,000 professionals across 110 countries, Syneos Health supports global clinical development programs and collaborates with industry leaders to improve healthcare outcomes. Over the past five years, the organization has contributed to 94% of all novel FDA-approved drugs and 95% of EMA-authorized products, demonstrating its strong impact in the global clinical research ecosystem.
Role Overview
The Senior Clinical Trial Assistant (Sr. CTA) / CTA III / Senior Clinical Operations Specialist supports clinical trial operations by coordinating clinical study activities, maintaining trial documentation, and assisting clinical monitoring teams with site management and study execution.
This role ensures that clinical trial activities are conducted in compliance with applicable regulatory requirements, ICH-GCP guidelines, corporate policies, and study protocols. The position also involves close collaboration with clinical teams, investigator sites, and internal stakeholders to ensure efficient clinical trial management.
Key Responsibilities
Clinical Trial Operations Support
Perform clinical operations activities in compliance with corporate policies, standard operating procedures (SOPs), and clinical trial guidelines.
Support clinical monitoring teams with site management activities and act as a sponsor representative for assigned clinical studies.
Site Coordination and Communication
Communicate with investigator sites to ensure adherence to clinical study protocols, procedures, and regulatory requirements.
Coordinate study-related communications between sites, project teams, and sponsors.
Clinical Trial Documentation Management
Create, organize, and maintain project files and clinical trial documentation.
Prepare and maintain investigator site manuals, reference materials, and other clinical study documents.
Clinical Data and Tracking Management
Maintain and update clinical trial tracking systems and databases.
Track incoming and outgoing clinical and regulatory documents associated with investigator sites and study teams.
Clinical Supply and Logistics Coordination
Coordinate ordering, packaging, shipping, and tracking of clinical trial supplies and study materials.
Ensure timely delivery of study materials to investigator sites.
Operational Coordination and Meeting Support
Manage shared project mailboxes and respond to site queries.
Coordinate team meetings, document meeting minutes, and track action items.
Quality and Compliance Support
Participate in internal file audits and ensure study documentation meets regulatory and compliance standards.
Identify operational issues proactively and implement corrective actions when necessary.
Training and Mentorship
Maintain up-to-date knowledge of clinical research processes and regulatory requirements through continuous training.
Provide mentorship or training support to junior Clinical Operations Specialists when required.
Educational Qualifications
Associate Degree, Bachelor’s Degree, or equivalent qualification in Life Sciences, Pharmacy, Clinical Research, or a related field.
Experience Requirements
3–6 years of experience in clinical research, clinical operations, or the pharmaceutical/biotechnology industry.
Experience supporting clinical trial management, documentation, and site coordination activities.
Technical Skills
Clinical Research Knowledge
Good understanding of clinical research processes, study protocols, and clinical trial operations.
Regulatory and Compliance Awareness
Familiarity with ICH-GCP guidelines, clinical data standards, and regulatory documentation requirements.
Clinical Data and Documentation Systems
Experience managing clinical trial documentation and maintaining clinical tracking databases.
Operational and Organizational Skills
Strong attention to detail with the ability to manage multiple tasks and deadlines efficiently.
Communication and Collaboration
Excellent written and verbal communication skills for coordination with clinical teams, sites, and stakeholders.
Technology Adaptability
Ability to quickly adopt new clinical research technologies, tools, and digital platforms.
Additional Information
Minimal travel may be required (approximately 10%) depending on study requirements.
The role requires the ability to work in a fast-paced clinical research environment while maintaining high standards of compliance and documentation accuracy.
Equal Opportunity Employer
Syneos Health is committed to creating a diverse, inclusive, and supportive workplace environment. The organization provides equal employment opportunities to all qualified candidates regardless of gender, race, disability, religion, or other protected characteristics, and offers reasonable accommodations where required.
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