Swati Bhargava

• Clinical Data Management Leader with expertise in Rare Disease, Advanced Therapies, and Diabetes Therapeutic Areas.
• Proven experience leading high-performing teams of clinical data insights and project managers within centralized data review functions.
• Skilled in driving operational excellence by establishing baseline criteria and efficiency parameters that enhance departmental Key Performance Indicators (KPIs), and overall performance.
• Adept at managing complex, resource-intensive therapeutic areas by applying deep functional expertise, and strategic resource oversight. Strong track record in leading cross-functional, interdisciplinary teams, resolving project challenges, and making data-driven decisions aligned with organizational goals.
• Brings in-depth knowledge of drug development, clinical trial processes, data acquisition, clinical data strategy, and risk-based quality management, and monitoring approaches.
• Recognized for a hands-on leadership style, and a consistent focus on innovation, collaboration, and delivery excellence in clinical data operations.
• Collaborated with cross-functional teams, aligning organizational objectives, and enhancing decision-making.

Senior Manager – Oncology and Immuno-Oncology Therapeutic Area.

• Led cross-functional teams to develop and implement data management strategies, enhancing operational efficiency and data integrity.
• Spearheaded initiatives to optimize data governance frameworks, resulting in improved compliance and reduced risk exposure across projects.
• Mentored junior staff on data management best practices, fostering a culture of continuous improvement and knowledge sharing within the team.
• Established key performance indicators for data quality metrics, driving accountability and enhancing decision-making processes across departments.
• Experienced in leading a team of people and project managers to ensure consistent, high-quality, and timely delivery of clinical data management projects across multiple country-specific studies.
• Accountable for resource planning and alignment in collaboration with Country Leads, driving project health, and operational success.
• Oversight responsibilities include managing SLAs, KPIs, and financial performance across projects, while monitoring key performance metrics to identify trends, and drive process improvements.
• Actively mentor managers to enhance leadership effectiveness, team engagement, and professional development. Skilled in optimizing resource utilization, ensuring cost efficiency, and promoting knowledge sharing across projects and departments.

• Manager – Oncology & Immuno-Oncology Therapeutic Area
• Led a team of people and project managers to ensure the consistent, timely, and high-quality delivery of clinical data management projects.
• Oversaw SLA and KPI tracking, finance reviews, and departmental performance metrics for client projects. Provided strategic leadership and mentorship to managers, focusing on enhancing managerial effectiveness, team development, and engagement.
• As the Oversight Project Manager, I managed resource planning to meet project objectives while maximizing efficiency and cost-effectiveness.
• Monitored project quality and performance trends, driving continuous improvement, and knowledge sharing across teams and departments.

• Led a team of data management professionals, overseeing resource planning, staff utilization, recruitment, performance management, and professional development.
• Provided expert guidance on key data management deliverables, including eCRF design, database setup, validation, and data management plans.
• Served as Project Manager for multiple large-scale studies, ensuring on-time, high-quality delivery while managing scope, budget, and client expectations. Actively contributed to departmental initiatives, process improvements, metrics tracking, and internal tool development.
• Collaborated with cross-functional teams to enhance efficiency, and ensure compliance with regulatory and operational standards.

• Served in a dual role as Line Manager and Data Team Lead (RAVE Database, 2014–2016), managing team performance, client deliverables, and issue resolution.
• Acted as the primary point of contact for data management activities, driving process improvements, and team development.
• Led training, performance reviews, and recruitment, while ensuring high-quality project execution.
• Also contributed as a Subject Matter Expert for external data and lab processes, and played a key role in metrics, SLAs, and productivity tracking initiatives.

• Served as the primary point of contact for data management deliverables and issue resolution, collaborating with clients, vendors, and internal teams. Acted as Subject Matter Expert for external data while driving process efficiency and training project teams.
• Full-time

• Data and Listings review, Query Management, Encoding
• Full-time

• Data Validation, Query Management, Performance of Quality Control
• Activities of Data and Project deliverables, Validate programmed edit checks
• Writing Edit Checks for both EDC Studies and Paper-studies. During the tenure I had also worked as a coordinator with the Institute Sai Bio Sciences and was involved in training and mentoring the freshers in the organization
• Full-time

• Key Responsibilities: Worked for a Project using Tissue Culture technique for finding the causes and the mechanism of Iron Chlorosis in Sugarcane
• Full-time