Hari Krishna Chanda

Associate Director- Cdm @OrciMed Life Sciences Private Limited

GB

Provide leadership, direction, and mentorship to the Clinical Data Management and SAS programming teams.Oversee the recruitment, training, and performance evaluation of team members, ensuring alignment with organizational goals and objectives.Lead the planning, execution, and completion of Clinical Data Management and SAS programming projects, ensuring adherence to timelines, budget, and quality standards.Coordinate with cross-functional teams, including clinical operations, biostatistics, regulatory affairs, and IT, to ensure seamless integration of Data Management and programming activities into clinical trials.Develop and implement Data Management plans, data validation plans, and data review guidelines for clinical trials.Oversee data collection, processing, and cleaning activities, ensuring data quality and integrity throughout the clinical trial lifecycle.Ensure compliance with regulatory requirements, industry standards, and best practices related to data management.Provide leadership and guidance in the development and validation of SAS programs for statistical analysis and reporting of clinical trial data.Review and approve SAS code, datasets, and statistical outputs to ensure accuracy, consistency, and compliance with predefined analysis plans and regulatory requirements.Establish and maintain quality management systems for clinical data management and SAS programming, including SOPs, work instructions, and data standards.Identify and mitigate risks related to data management and programming activities, implementing appropriate risk mitigation strategies and contingency plans.Ensure timely escalation of issues and resolution of discrepancies to minimize impact on clinical trial timelines and deliverables.