Dr. Neeta Nargundkar

Dynamic Managing Director with extensive experience at Biosphere Clinical Research Pvt Ltd, excelling in regulatory compliance and strategic project management. Proven track record in optimizing clinical operations and budget management, while fostering team collaboration and stakeholder engagement. Adept at leading clinical trials and ensuring quality assurance across diverse projects. Seasoned Managing Director with strong leadership skills and significant experience in strategic planning, team building, and financial management. Highly skilled at driving growth by leveraging resources, creating partnerships, and aligning operational processes to business objectives. Demonstrated success in developing effective strategies that significantly improve efficiency and bottom-line profit. Known for fostering innovation, managing risk effectively, and leading cross-functional teams to achieve organizational goals.

Date of Birth: 06/21/72

• Ensure ICH / GCP and applicable regulatory requirement compliance for all sponsored clinical studies
• Ensure internal departmental SOP and ICH / GCP and applicable regulatory compliance, and optimize general operation of the department
• Supports the study team during inspections by Regulatory authorities or audits.
• Proposing strategies and solutions to address the needs of performing clinical studies
• Budget preparation and management associated with clinical studies and overall clinical programs
• Authoring and review of documents required for clinical studies
• Collaborate with members of Clinical Trial Team(s) to develop clinical trial protocol summary, protocols, Informed Consent Form/Patient Information and other trial documents (e.g. CRF, Monitoring Guidelines, data cleaning plans, statistical analysis plans, vendor contracts)
• Participate in clinical summary document generation (e.g. INDs, NDAs) and other submission activities for study specific issues, results or analysis and description of individual cases
• Accountable for ensuring project deliverables met within clinical study timelines
• Monitor external environment with respect to new technology, methodology, regulations and guidelines emerging to support/guide or govern the conduct of clinical studies
• Ongoing evaluation of internal processes as part of helping to ensure compliance with respect to the performance of clinical studies

Managing Director, 2012