Sunil Kumar Nagaraja

Assessed source documents meticulously to guarantee completion in alignment with established regulatory frameworks and ICH GCP protocols.

Conducted assessments of IP accountability and management practices to maintain adherence to sponsor and regulatory requirements.

Developed training materials for new staff, promoting adherence to quality control protocols.

Analyzed trends to identify improvement areas, contributing to enhanced data quality and integrity.

Identified protocol deviations and analyzed root causes and developed solutions to prevent recurrence by implementing CAPA.

Review ISF for completeness.

Assessed informed consent documents to ensure compliance with ethical guidelines and GCP regulations.

Spearheaded optimization and management of standard operating procedures.

Medical Monitor

• Collaborated with research teams to evaluate clinical trial protocols and monitor patient safety throughout the study.
• Facilitated recruitment of eligible patients for clinical trials to ensure compliance with study protocols.
• Delivered comprehensive training sessions to enhance site personnel's understanding of study procedures and protocols.
• Oversaw compliance with good clinical practices during all phases of study execution.
• Conducted thorough reviews of adverse event reports from sites during trials and relayed critical findings to sponsors and principal investigators.
• Managed safety assessment inquiries across multiple sites, ensuring timely and accurate responses to all queries. Oversaw the collection and analysis of site safety assessment feedback, enhancing overall safety compliance. Coordinated safety assessment processes at multiple locations, driving improvements in site safety protocols.
• Analyzed data listings from various sources to ensure accuracy, identifying discrepancies and facilitating necessary corrections with relevant sites.
• Advised site teams on effective patient management strategies for individuals meeting criteria for enhanced monitoring or study discontinuation.
• Protocol deviation management: Identified protocol deviations and classified it into important and non important PDs.

Medical reviewer

• Analyzed ICSR data to determine causality, seriousness, and expectedness of molecules associated with specific events, enhancing safety assessments.
• Ensured accurate coding of reported events in compliance with MedDRA standards.

• Oversaw the design and implementation of clinical trials aimed at determining drug safety and bioequivalence standards.
• Conducted studies with strict adherence to SOPs, ethical standards and regulatory requirements, ensuring subject safety and well being as the central focus.
• Provided inputs for development of informed consent documents for participant recruitment.
• Mentored junior staff on best practices in clinical research methodologies.
• Participated in training sessions with investigative sites to ensure proper understanding of GCPs and protocol requirements.
• Reviewed literature related to therapeutic area and Investigational product to provide operational feasibility.
• Reviewed and provided inputs for development of case report forms.
• Identified potential risks associated with clinical trials prior to initiation of studies.
• Faced regulatory audits like US FDA, EMEA and DCGI
• Managed laboratory inventory and ensured compliance with safety regulations.
• Collaborated with cross-functional teams to facilitate trial operations and streamline data collection processes.
• Demonstrated commitment to ethical research practices by adhering to regulatory guidelines and maintaining patient confidentiality at all times.

• Facilitated input gathering for comprehensive protocol development.
• Managed BA/BE studies with limited oversight. Oversaw screening and selection of potential study volunteers. Administered informed consent procedures to participants. Supervised participant dosing protocols. Guaranteed integrity of data collection methods. Advocated for the safety of subjects during trials. Delivered accurate safety documentation to sponsors, ethics committees, and regulatory bodies.
• Ensured trial is completed as per GCP and regulatory guidelines
• Strict adherence to GDP
• Mentored junior researchers on best practices and methodologies.
• Oversaw adherence to ethical standards in all research activities.

• Performed screening and identification of potential volunteers for the trail.
• Administered Informed consent and supervised dosing activities.
• Coordinated data collection and analysis for regulatory submissions.
• Medical management of reported adverse events by prioritizing safety first concept.
• Reviewed scientific literature to support ongoing research initiatives.
• Ensured compliance with ethical standards in all research activities.
• Monitored overall progress of projects against timelines and deliverables ensuring timely completion.
• Safety management and documentation

• In patient hospital care.
• Managed patient care and coordinated treatment plans with healthcare teams.
• Conducted comprehensive patient assessments and documented findings accurately.
• Collaborated with multidisciplinary teams to enhance patient outcomes and safety.

• Diagnosed patient conditions through thorough physical examinations and medical history reviews.
• Developed and implemented treatment plans tailored to individual patient needs in coordination with the consultants.
• Collaborated with multidisciplinary teams to ensure comprehensive patient care.
• Performed out patient and in patient routine medical care procedures.