Required Attributes : At least 10 years of experience in the clinical operations field.
Previous experience in field operations (CRA role) is an asset.
• Knowledge of drug development and registration process in India.
• In-depth understanding of the overall clinical trial process, androles of all functions on the study team, including vendors
...
• Strong knowledge for best practices within clinical research, process improvement and compliance with standard operating procedures and clinical trial regulations including ICH-GCP Responsibilites: Accountable for the planning and execution of clinical studies in line with quality standards, agreed timelines and budget from study synopsis to archiving Builds and leads the study team by identifying and engaging the appropriate functions (internal and external staff) based on the type and complexity of the study. Organizes and schedules study teammeetings. Establishes, promotes and maintains strong working relationships within the study team, and across relevant functions. Ensure agreed actions are followed-up.
Proactively identify study risks and ensure appropriate mitigation plans execution. Manage contingencies plan proactively and lead problem solving and resolution efforts to ensure studycontinuity and quality.
experience
15show more Required Attributes : At least 10 years of experience in the clinical operations field.
Previous experience in field operations (CRA role) is an asset.
• Knowledge of drug development and registration process in India.
• In-depth understanding of the overall clinical trial process, androles of all functions on the study team, including vendors
• Strong knowledge for best practices within clinical research, process improvement and compliance with standard operating procedures and clinical trial regulations including ICH-GCP Responsibilites: Accountable for the planning and execution of clinical studies in line with quality standards, agreed timelines and budget from study synopsis to archiving Builds and leads the study team by identifying and engaging the appropriate functions (internal and external staff) based on the type and complexity of the study. Organizes and schedules study teammeetings. Establishes, promotes and maintains strong working relationships within the study team, and across relevant functions. Ensure agreed actions are followed-up. ...
Proactively identify study risks and ensure appropriate mitigation plans execution. Manage contingencies plan proactively and lead problem solving and resolution efforts to ensure studycontinuity and quality.
experience
15show more
