Location: Bangalore, India
Department: Clinical Operations
🌟 About Syngene International
Syngene International Ltd. is a leading innovation-driven contract research, development, and manufacturing organisation (CRDMO) offering integrated scientific services from early discovery to commercial supply. With a strong commitment to excellence, Syngene supports global pharmaceutical and biotechnology companies in accelerating their drug development pipelines.
At Syngene, safety is a core value—not just a protocol. The company fosters a culture where safety is treated with the same importance as business performance. Every employee is expected to uphold safety standards, contribute to safe practices, and complete mandatory training related to data integrity, health, and environmental safety.
Learn more about Syngene at www.syngeneintl.com
Role Overview: Senior Clinical Research Associate
As a Senior CRA, you will play a pivotal role in managing clinical trial sites and ensuring 🧭 the quality and integrity of data collected. You will be responsible for site selection, initiation, monitoring, and close-out visits in accordance with Good Clinical Practice (GCP) guidelines and regulatory requirements.
This role demands strong organisational skills, attention to detail, and the ability to work collaboratively across teams. You’ll be part of a dynamic Clinical Operations department, contributing to the success of global clinical trials.
🔍 Key Responsibilities
Conduct site selection, initiation, monitoring, and close-out visits as per protocol and regulatory standards.
Manage assigned study sites and therapeutic areas, ensuring compliance and data integrity.
Administer protocol and study-related training to site staff.
Maintain regular communication with sites to manage expectations and project activities.
Investigate quality issues and collaborate with Clinical Project Managers to implement corrective and preventive actions.
Track regulatory submissions, ethics committee approvals, subject recruitment, CRF completion, and data query resolution.
Document site management activities, monitoring visit findings, and action plans.
Submit timely visit reports, follow-up letters, and other study documentation.
Assist Clinical Project Managers in designing study tools and processes.
May be assigned as Lead CRA to support project coordination and delegation of responsibilities.
🧠 Skills & Capabilities
Strong verbal and written communication skills.
Ability to work in a fast-paced, dynamic environment.
Capable of managing multiple tasks and meeting tight deadlines.
Creative problem-solving and solution-oriented mindset.
Team player with a focus on collaboration and accountability.
Commitment to safety, quality, and compliance.
🎓 Education & Experience
Education Requirements:
M.Sc, M.Pharm, Pharm D, BAMS, BDS, MDS, BHMS, or any life science degree.
Experience Requirements:
3 to 9 years of experience in clinical research, preferably in site monitoring and management.
Familiarity with eTMF systems and regulatory documentation is a plus.
🌱 Syngene Values
All employees are expected to demonstrate alignment with Syngene’s core values:
Excellence
Integrity
Professionalism
These values guide every aspect of work at Syngene—from scientific innovation to operational discipline.
📬 How to Apply
Ready to take your career to the next level?
Apply now via:
👉 Syngene Careers – Sr CRA
Or visit the careers page: www.syngeneintl.com
🚀 Join Syngene and Transform Science into Solutions
Be part of a global team where your expertise in clinical research directly contributes to shaping the future of healthcare innovation.