Manish Pudke

Background

About Manish Pudke

As a Clinical Research Coordinator (CRC) at Hector Research Archival Pvt. Ltd, I have spent the last 1.5 years managing and coordinating clinical trials, ensuring compliance with regulatory requirements, and supporting the efficient execution of research projects. My role involves working closely with principal investigators, study sponsors, and regulatory bodies to deliver high-quality data and maintain ethical standards throughout the research process. I am skilled in: Trial Management: Coordinating day-to-day operations, patient scheduling, and ensuring accurate documentation. Regulatory Compliance: Ensuring adherence to GCP, FDA, ICH guidelines, and local regulations. SAE Reporting: Efficiently identifying and reporting Serious Adverse Events (SAEs) as per required timelines and protocols. Regulatory Document Submission: Preparing and submitting regulatory documents for approval to ethics committees (EC), regulatory authorities, and study sponsors. Documentation: Managing accurate and complete documentation for clinical trials, ensuring all records are in compliance with regulatory standards. Data Management: Ensuring data integrity, accuracy, and security, including data entry and analysis. Sponsor Audits: Successfully facing sponsor audits, ensuring trial compliance, and addressing any audit findings with appropriate corrective actions. Patient Interaction: Managing patient recruitment, obtaining informed consent, and maintaining positive relationships throughout the trial process. Team Collaboration: Working with cross-functional teams to ensure smooth trial operations and effective communication. At Hector Research Archival, I have contributed to several successful trials, particularly in urology, cardiology, and nephrology. My experience spans across these therapeutic areas, where I have been involved in patient recruitment, SAE management, regulatory documentation, and ensuring trial compliance. I take pride in my ability to manage complex tasks and ensure that trials are conducted with the highest levels of integrity and efficiency. Looking ahead, I am excited to expand my career by moving into roles such as Clinical Research Associate (CRA) or Clinical Trial Assistant (CTA), where I can further leverage my experience in trial management, monitoring, and regulatory compliance. My ultimate goal is to contribute to the development of innovative therapies that improve patient outcomes while advancing my skills in clinical research.