DINESH LENDAVE

Key Responsibilities:

• Managing and abstracting oncology-specific clinical trial data from EMRs into EDC platforms such as Rave, Medidata, REDCap, Clario, OnCore, CAISIS, and Palantir.
• Working primarily on Phase I and Phase II oncology clinical trials focused on safety, dose escalation, efficacy endpoints, and biomarker evaluation.
• Ensuring high-quality, accurate capture of cancer-specific endpoints, lab data, and treatment responses.
• Adhering to oncology protocol requirements and ensuring compliance with ICH GCP, ICMR, and GxP guidelines.
• Avoiding the use or exposure of PHI (Protected Health Information) during data abstraction and documentation processes.
• Performing timely data entry and resolving queries related to screening data, demographics, protocol compliance, biopsies, chemotherapy, radiation therapy, adverse drug reactions (ADR), concomitant medications (ConMed), laboratory results, surgical interventions, and types of cancer.
• Reviewing source documentation to ensure consistency with case report forms (CRFs), and protocol-defined parameters.
• Collaborating effectively with clinical teams, data managers, and other stakeholders to ensure data integrity, and to support timely and accurate submission of clean data for interim and final analyses.
• Supporting SAE tracking, tumor response assessments, and survival follow-up data.

• Involved in daily dispensing activities.
• Involved in the evaluation, selection, and training of production personnel.
• Review of the batch manufacturing records.
• To perform all batch manufacturing activities.