Abhishekh

- Oversaw CRA duties within the Quality Monitoring Team, ensuring high standards of research integrity and compliance. Successfully conducted close-out visits to conclude study activities. - - - - - - Monitored and facilitated the completion and release of Case Report Forms (CRFs) and other clinical documentation. Ensured adherence to protocols at study sites, clinical labs, and biorepository labs. Documented and addressed queries in accordance with regulatory standards/ QMP (Quality Management Plan). Collaborated closely with the clinical team to maintain study integrity and compliance. Led site management activities, including site selection, initiation, conduct, and closure of studies in compliance with local regulations, ICH-GCP, and protocol requirements to ensure data quality and study subject protection. Managed patient recruitment at site level, ensuring successful completion of the clinical program. Personnel Coordination: - Reporting to with Clinical Team Lead Manager (TL) and Project and (PM/QM) via SCU & weekly updates meeting, communicating progress and critical issues that could impair trial progress. Occasionally interacted directly with Chief- Clinical Portfolio Managers (CPM). Technical Proficiency: - Utilized IT systems (e.g., Clindox, RedCap, OctalSoft, ODK & DMS) proactively for site visit preparation, conduct, and Source Data Verification (SDV) in collaboration with the data management team.

Spearheaded Regulatory Documentation Processes, including the preparation and review of Certificates of Analysis (COAs) and Drug Master Files (DMFs), ensuring stringent adherence to compliance standards. - - - - Conducted in-depth market research and contributed to Corrective and Preventive Actions (CAPA) for oncology products, aligning strategies with regulatory and clinical demands. Designed and delivered targeted training programs, product demonstrations, and presentations, enhancing product understanding and promoting clinical efficacy through detailed data-driven presentations. Managed quality inspections for parenteral preparations, addressing Temperature Excursions using temperature data loggers across Dalrec’s India supply chain. Ensured regulatory compliance in product labelling, packaging, and Package Insert Leaflets (PIL) by reviewing and approving product artwork in line with regulatory requirements.

- Conducted Site Initiation Visits (SIV), Monitoring Visits (MV), and Close-Out Visits (COV) across different study phases, ensuring compliance with regulatory standards and approved protocols by SER-IEC. - - - Proactively monitored Data Accuracy and Integrity in clinical documents, including Case Report Forms (CRFs), Informed Consent Forms (ICFs), and Study Protocols, by maintaining continuous oversight aligned with SOPs and regulatory standards. Organized and facilitated Ethics Committee Meetings, handling all required documentation and Regulatory Submissions, ensuring thorough documentation and precise records of ethical compliance and review outcomes. Conducted Quality Control Audits of clinical trial documents, including study files, CRF files, and monitoring files, by effectively distributing and managing the workload.