Roles & Responsibilities:
• Coordinate with Sponsors and internal Operations teams for clinical trial feasibility with quick turnaround times.
• Oversee ethical conduct of Phase II–IV clinical trials in compliance with ICH-GCP and regulatory standards.
• Ensure timely completion of clinical trials with high-quality, error-free data collection from sites.
• Drive repeat business from Sponsors/CROs through superior site performance and delivery.
• Train and mentor operations teams on essential clinical trial documents and ethical trial conduct.
• Lead recruitment, capacity building, and performance development of the clinical operations team.
• Handhold teams throughout the entire clinical trial lifecycle and identify high performers for vertical growth.
• Prepare sites for FDA audits and ensure audit readiness.
• Develop new clinical trial sites across India, including non-metro locations, and build therapeutic area–specific investigator networks.
• Establish and implement SOPs, operational systems, controls, and efficient marketing processes.
• Prepare business plans, achieve targets, and continuously improve operational and marketing strategies.
• Anticipate risks, mitigate issues proactively, and ensure adherence to sponsor timelines.
• Monitor market trends, gather industry intelligence, and keep management informed.
• Prepare MIS and management reports and maintain strict control on headcount.
Qualification:
• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, or related field.
Experience:
• Extensive experience in clinical operations with strong exposure to Phase II–IV clinical trials and site management.
Skills:
• Strong leadership and team-building capabilities.
• Excellent sponsor and stakeholder management skills.
• Deep understanding of clinical trial operations, ethics, and regulatory compliance.
• Strategic planning, risk management, and business development skills.
• Ability to work across metro and non-metro clinical trial sites.
• Strong communication, training, and reporting skills.
About the Organization:
The organization operates in the clinical research domain with a focus on ethical, high-quality clinical trial execution across India. It emphasizes operational excellence, regulatory compliance, strong investigator networks, and sustainable growth through robust systems, processes, and team development.
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