Rohini Dwarkanath

Accomplished Clinical Data Management Professional with 15+ years of experience in a managerial role, supporting global pharmaceutical customers. Demonstrated expertise in program and project management, financial oversight, forecasting, and timeline management. Proficient in organizational and business strategy, process optimization, team leadership, and mentoring. Successfully managed clinical trials from study setup to closeout, spanning Phase I to Phase III, consistently delivering high-quality data management solutions. Proven track record of maintaining strong client and stakeholder engagement.

• CDM professional Development Certificate Program, The CRA Training Institute, Houston, Texas, USA, 12/19
• IELTS, British Council, India, India, 08/17

• Neuropsychiatry: Bi-polar Disorder, Major Depressive Disorder
• Central Nervous System: Pain Management
• Cardiovascular: Hypertension
• Respiratory Disorders: Chronic Obstructive Pulmonary Disorder (COPD)
• Gastroenterology: Irritable Bowel Syndrome (IBS)
• Blood Disorders: Hemophilia

Led programs in Respiratory Disorders, Central Nervous System, Neuropsychiatry, and Pain Management studies, managing a team of 30 data managers and overseeing a budget of $5 million. Actively participated in Sponsor and Internal Audits. Represented Data Management team in RFP meetings., Spearheaded strategic planning, process definition, and timeline execution with effective monitoring of timelines and budgets to ensure high-quality deliverables., Change request management, timeline negotiations, risk management discussions., Collaborated closely with cross-functional stakeholders to define KPIs, KRIs, and vendor processes. Coordinated with SDTM, Medical, and Clinical teams to ensure smooth and seamless data delivery. Standardized the Query Writing and Handling processes, leading to a 50% reduction in re-queries across both EDC and vendor data., Led a project focused on optimizing processes to enhance data quality, increasing Quality Index from 98% to 99.5%, surpassing the sponsor's target of 99%., Contributed as a core team member to the capability development initiative, driving improvements across functions such as data validation, medical coding, and user acceptance testing (UAT).