Job Title: Sr. Clinical Trial Assistant (Sr. CTA) / CTA III / Sr. Clinical Operations Specialist
Company: Syneos Health
Location: India – Client Location
Job Type: Full-Time
Experience Required: 3–6 Years of Experience in Clinical Research, Clinical Operations, or the Pharmaceutical/Biotechnology Industry
About Syneos Health
Syneos Health is a leading global biopharmaceutical solutions organization that integrates clinical development, medical affairs, and commercial capabilities to accelerate customer success. The company partners with pharmaceutical, biotechnology, and healthcare organizations to bring innovative therapies to patients faster and more efficiently.
With more than 29,000 professionals across 110 countries, Syneos Health delivers comprehensive clinical research and development solutions. Over the past five years, the organization has supported 94% of all novel FDA-approved drugs and 95% of EMA-authorized products, demonstrating its strong global presence in the clinical research ecosystem.
Role Overview
The Sr. Clinical Trial Assistant (Sr. CTA) / CTA III / Sr. Clinical Operations Specialist provides operational and administrative support to clinical trial teams to ensure the successful execution of clinical research studies. The role involves managing clinical documentation, coordinating study activities, and supporting clinical monitoring teams in site management and trial operations.
The position plays an important role in ensuring clinical trials are conducted in compliance with study protocols, regulatory requirements, ICH-GCP guidelines, and internal corporate policies.
Key Responsibilities
Clinical Trial Operations Support
Perform clinical trial activities in accordance with corporate clinical operations policies, standard operating procedures (SOPs), and work instructions.
Assist clinical monitoring teams with investigator site management and trial coordination.
Site Coordination and Communication
Act as a sponsor representative for assigned clinical trial sites.
Communicate with investigator sites to ensure compliance with clinical protocols, study procedures, and regulatory guidelines.
Clinical Documentation and File Management
Create, organize, and maintain clinical trial project files and documentation.
Prepare and maintain investigator site manuals, study reference tools, and supporting documentation.
Clinical Data Tracking and Database Management
Maintain and update clinical trial tracking systems and databases.
Monitor and record incoming and outgoing clinical and regulatory documentation related to study sites and project teams.
Study Logistics and Supply Coordination
Coordinate ordering, packaging, shipping, and tracking of clinical trial materials and site supplies.
Ensure timely distribution of study materials to investigator sites.
Communication and Operational Support
Manage shared project mailboxes and respond to investigator site queries.
Route communications and documentation to appropriate project stakeholders.
Meeting Coordination and Documentation
Assist in scheduling and coordinating project meetings.
Prepare detailed meeting minutes, track action items, and support follow-up activities.
Quality and Compliance Monitoring
Participate in internal file audits and documentation reviews.
Identify potential operational challenges and implement corrective actions where necessary.
Training and Knowledge Development
Maintain awareness of clinical research best practices, regulatory standards, and industry developments through ongoing training.
Provide mentorship or guidance 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 trial operations, clinical research coordination, or pharmaceutical/biotechnology industry roles.
Experience supporting clinical trial documentation, site coordination, and clinical project teams is preferred.
Technical Skills
Clinical Research Knowledge
Strong understanding of clinical trial processes and clinical research operations.
Regulatory and Compliance Awareness
Knowledge of ICH-GCP guidelines, clinical documentation standards, and regulatory requirements.
Clinical Data and Documentation Management
Experience maintaining clinical tracking systems and managing study documentation.
Organizational and Multitasking Skills
Ability to manage multiple tasks, prioritize responsibilities, and maintain high attention to detail.
Communication and Collaboration
Strong written and verbal communication skills to interact with investigator sites, sponsors, and cross-functional teams.
Technology and Systems Adaptability
Ability to work with clinical research software, databases, and digital collaboration tools.
Additional Information
Minimal travel may be required (approximately 10%) depending on project requirements.
The role requires strong organizational skills and the ability to work effectively in a fast-paced clinical research environment.
Equal Opportunity Employer
Syneos Health is committed to building a diverse, inclusive, and equitable workplace. The company provides equal employment opportunities to all qualified individuals regardless of race, gender, religion, nationality, disability, or other protected characteristics. Reasonable accommodations are provided in accordance with applicable laws and regulations.
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