Senior Clinical Data Coordinator (Standards) in Chennai, भारत

Senior Clinical Data Coordinator role at ICON involves designing and analyzing clinical trials while managing complex medical data. The position requires leading data management initiatives, ensuring regulatory compliance, and mentoring junior coordinators in a sponsor-dedicated model.

Responsibilities

• Design and maintain detailed data management plans with regulatory compliance documentation
• Identify, resolve, and streamline data discrepancies to enhance quality throughout study lifecycle
• Develop and execute data management strategies collaborating with clinical operations and biostatistics teams
• Mentor junior data coordinators on data reconciliation, coding, and cleaning procedures
• Support project activities including documentation archiving and investigator site query management

Requirements

• Bachelor's degree in Life Sciences, Healthcare, or related field
• Proven clinical data management experience in pharmaceutical or biotechnology industry
• Proficiency with data management software such as Medidata or Oracle RDC
• Strong attention to detail and ability to work independently in fast-paced settings
• Excellent cross-functional collaboration and communication skills
• Knowledge of ICH-GCP and regulatory guidelines preferred
• Willingness to travel approximately 5% as required