Vidhuna Sadanandan

● Talent Acquisition and Performance Management: Staff recruitment, monitoring workload to track appropriate staffing levels and contributing to the execution of affirmative actions in the department. Development of staff and management of staff performance by setting employee objectives based on strategic goals.

● Resource & Budget Management Familiarize with cost metrics for data management, assigns personnel to ensure study deadlines and financial budgets are met, tracks data for success metrics, contributes to the development and implementation of plans, policies, and procedures within department guidelines to improve work quality, efficiency, productivity, and expense control of the global data management group.

● Process Optimization & Compliance: Upholds training principles of a regulated environment, ensuring required training for staff members is completed and documented, helps develop training plans, ensures new staff members are adequately trained in a reasonable timeframe, delivers appropriate overview training sessions for other members of the department, informing them of the roles and responsibilities of the global data management team.

● Training & Development: Development and delivery of comprehensive training programs, fostering a culture of continuous learning and development within the team.

● Data Management & Innovation: Created and validated datasets in compliance with regulatory standards.

● Data Standardization Leadership:Actively drives data standardization initiatives across departments and within industry consortia, ensuring alignment with evolving standards.

● Client & Stakeholder Engagement:Builds and maintains strong client relationships, effectively communicating data standardization capabilities and strategies to diverse audiences.

● Data Process Optimization: Streamlines dataset production workflows, leveraging automation and new technologies to enhance accuracy and efficiency.

● Team Development & Training: Mentors and trains new staff, fostering a culture of continuous learning and knowledge sharing.

● Software Validation & Enhancement: Leads software validation efforts, ensuring compliance with regulatory standards, and collaborates on software enhancement projects.

• Analyzed preclinical study data, identified gaps, and created SEND datasets using Xybion tools, ensuring compliance and performing QC.
• Provided SEND consultancy services to clients, addressing their queries and offering solutions.
• Developed in-depth knowledge of Pristima, Savante, and Labwise products, providing feedback for enhancements.
• Stayed updated on FDA & CDISC regulatory requirements for non-clinical study data submission; Mentored new team members.
• Ensured quality deliverables while working in a fast-paced environment to meet targets.

• Proficient in FDA regulations, ICH GCP, SDTM/SEND models, CDISC, medical terminology, and database development within the drug development process.
• Led data standardization for non-clinical studies, creating compliant datasets and editing nSDRG/Define.xml.
• Developed and executed test plans for database validation, ensuring data integrity.
• Consistently delivered high-quality, standardized data, meeting regulatory requirements.
• Conducted SEND Assure analysis to validate study data against reports, preparing comprehensive validation reports.

• Study Documentation Management: Maintained source documents, CRFs, ISFs per ICH-GCP guidelines.
• Investigational Product (IP) Handling: Ensured proper storage and handling of IP as per protocol requirements.
• Ethics Committee (EC) Submissions: Completed and submitted regulatory documents to EC, facilitating study initiation and conduct.
• Laboratory Coordination: Liaised with local and central laboratories to streamline sample processing and analysis.
• Subject Recruitment and Safety: Assisted in patient recruitment, informed consent process, and timely adverse event reporting.

● Offered courses on Plant Biotechnology, Molecular Biology, Environmental Biotechnology, Immunology and Genetic engineering for undergraduates and postgraduates.

● Designed and executed labs for undergraduates and postgraduates, guided undergraduates and postgraduate students in final year projects as part of their curriculum.

● Extensive research experience and teaching assistantship in the relevant subject area including the production of relevant outputs and managing students.