Visionary, strategic leader with over 22 years of experience in clinical trial data and systems management, execution and operations in various therapeutic areas in biotech/ pharma industry. Experienced in creating strategic technology roadmap for Clinical Development Operations/ Clinical Data Management, driving process optimization/ digital transformation and successful implementations of novel technologies for clinical trial execution and operations with an aim of optimizing delivery and efficiency, delivering cost savings, improving clinical trial access to patients across the globe. Experience developing, leading and managing high-performing teams.
Skilled in implementing and managing Electronic Data Capture (EDC) platforms, Decentralized (DCT)/Virtual/Hybrid Trial Technology Solutions(eCOA, eDiary, eConsent, Telehealth, Patient centric/ Site centric solutions, sensors, wearables, eSource, EHR-EDC integrations), CTMS, Data integrations with IRT/Safety systems, eTMF, Clinical Data Warehouse, Pinnacle21 enterprise system and reporting/analytics solutions. Experienced in managing all data receipt, SDTM generation and SDTM submissions Delivery. Experienced in managing Data Analytics/ Reporting solutions for Cross-functional Clinical/ Medical Data Review, Risk-based data quality monitoring, business intelligence and oversight. Experience with developing and managing Clinical Data Collection Standards & Governance.
Strong knowledge of GCP and regulatory requirements. Experience leading and overseeing CSV deliverables for implementation of new technologies as business owner. Experience with audits/ inspections from agencies like FDA, PMDA, MHRA, EMA. Skilled in Continuous Process improvement and performance management, vendor governance, developing KPIs, Operations and Quality Metrics for overseeing vendors, strategic partnerships (FSP, Full-service CROs, Technology vendors). Experience supporting mergers and acquisitions (M&As) and spin-offs.
