Nagapriya Mahanandi

• Lead global cross-functional study teams, acting as the primary operational lead and escalation point for study delivery and performance
• Drive execution of clinical trials ensuring alignment with protocol, timelines, budget, and data quality expectations
• Partner with clinical development, biostatistics, and regulatory teams to provide operational input into protocol design and study strategy
• Lead feasibility assessments and data-driven country and site selection strategies
• Oversee investigator meetings, ensuring scientific alignment and operational readiness
• Provide oversight for key study deliverables including CRFs, DMPs, monitoring plans, and data review plans
• Ensure robust data quality and integrity, tracking metrics, query resolution timelines, and database readiness
• Manage CROs and vendors end-to-end, ensuring accountability and performance aligned with scope and quality expectations
• Lead risk identification and mitigation using proactive, data-driven approaches, ensuring minimal impact to timelines
• Oversee patient recruitment strategies and enrollment performance, implementing corrective actions as needed
• Ensure compliance with CTMS, eTMF, and clinical trial registry requirements
• Drive study close-out including database lock, TMF reconciliation, and clinical study report support
• Mentor and develop team members, fostering a collaborative, high-performance culture

• Supported global trials with a focus on operational excellence, study metrics, and quality-driven execution
• Collaborated across functional teams (clinical development, data management, safety) to ensure integrated study delivery
• Identified study risks and supported implementation of mitigation strategies balancing timelines and cost
• Contributed to protocol development and study documentation including CRFs, data review plans, and CSRs
• Directed TMF oversight to ensure inspection readiness and completeness
• Managed vendor deliverables and budgets in alignment with SOW and study objectives
• Participated in inspections and audit readiness activities, ensuring compliance with regulatory expectations

• Led global biosimilar clinical trials from initiation to close-out, ensuring scientific and operational alignment
• Directed CRO/vendor selection, contracting, and performance management across global studies
• Led study start-up including feasibility, site selection, TMF setup, and investigator engagement
• Ensured compliance with global regulatory requirements and trial transparency standards
• Implemented risk management frameworks and contingency strategies to maintain study timelines
• Oversaw monitoring activities and ensured data quality, protocol adherence, and issue resolution
• Maintained continuous inspection readiness and TMF quality
• Managed study budgets and financial tracking, ensuring efficient resource utilization

• Supported execution of global trials with focus on operational coordination and documentation
• Maintained TMF and ensured data and document quality standards
• Coordinated cross-functional communication across sites, CROs, and internal teams

High-level analysis of gene expression microarrays and SNP microarrays
Mcode (Molecular complex detection) detecting highly interconnected regions in large protein- protein interaction networks that represent molecular complex
Cytoscape to perform Network analysis of expressed genes in gene-gene interaction