Anindita Mandal

Collaborated closely with Biostatistics, Clinical Operations, and external vendors to optimise data workflows and maintain regulatory readiness, thereby mitigating compliance risks. Managed three therapeutic studies focused on respiratory conditions, employing agile methodologies to enhance task prioritisation, operational efficiency, and safeguard the integrity of critical clinical data. Successfully completed the database lock of a legacy trial initiated in 2017, adhering to stringent regulatory timelines while delivering high-quality data, thereby reinforcing the organisation's reliability and credibility. Reviewed and developed essential clinical study documents, including protocols, CRFs, Data Management Plans (DMPs), and Data Transfer Agreements (DTAs), ensuring document accuracy, regulatory compliance, and procedural alignment. Championed database build activities, including user acceptance testing coordination, edit check specification reviews, and final data archiving, which significantly improved data quality and ensured long-term data accessibility. Delivered targeted peer training on EDC-IRT integration and external vendor data reconciliation, boosting team knowledge and execution capabilities.

Acted as the SDTM subject matter expert, leading the project team to ensure the delivery of high-quality clinical data management services that met client expectations and adhered to regulatory standards. Directed project activities across multiple Oncology and vaccine studies, ensuring timely delivery within contract specifications while upholding high data integrity. Mentored and supported junior data managers, nurturing their professional growth and consistently maintaining quality standards in data management deliverables.

Oversaw all Clinical Data Management activities for assigned Oncology projects, ensuring adherence to project timelines and quality standards. Communicated effectively with sponsors and collaborators regarding data management issues, fostering collaborative problem-solving. Produced and maintained essential study-related documentation to support project integrity and regulatory compliance. Ensured Case Report Form (CRF) design met study data collection requirements, defining and reviewing edit checks in the Data Validation Plan to enhance data quality. Coordinated external data transfers and reconciliations with the clinical database, ensuring data consistency and accuracy.