
Healthcare professional with 5+ years of diverse, international experience in healthcare administration, clinical documentation, and public health. Transitioning into Clinical Data Management (CDM) within a CRO environment, with a solid understanding of the clinical trial data lifecycle, data cleaning, and data quality management. Trained in regulatory compliance (ICH-GCP, FDA, GDPR), and equipped to support accurate and timely clinical data delivery. Seeking a Clinical Data Specialist or Clinical Data Coordinator role to leverage conceptual knowledge of EDC systems (Medidata Rave, Oracle Clinical, Veeva Vault, EHR), and regulatory compliance.
ICH-GCP, FDA Compliance, GDPR (Conceptual) Data Integrity & Quality Checks Clinical Documentation Data Cleaning & Query Resolution (Conceptual) Study Start‑Up & Close‑Out (Conceptual) Medidata Rave, Oracle Clinical, Veeva Vault, EHR Systems (Conceptual) Power BI Voyager Microsoft PowerPoint Microsoft Excel Data Extraction & Analysis Regulatory Compliance in Clinical & Public Health Settings Scientific & Medical Knowledge Acquisition Patient & Client Coordination Clinical Coordination Team Collaboration Attention to Detail Problem Solving Effective Communication Time Management Compliance Adherence Languages: English, Hindi, Marathi