Nilamadhab Nayak

• > An individual patient data registry preparation for cancer care and outcomes is being developed in collaboration with six other centers across India (JIPMER, IMS & SUM, Amala, AIIMS Rishikesh, CMC Ludhiana, and MMRC).
• > Coordinated for setting up a new Clinical Research Unit, especially in the field of Oncology (Infrastructure setup, Laboratory equipments, Calibration, Manpower, Training, SOP Preparation).
• > Conducted different registry trials in Brest cancer, Ovarian Cancer and Colorectal cancer from Sponsors like AstraZeneca, Dr. Reddy's laboratories, Pfizer, Bristol-Meyer(BMS).
• > Helps IEC(Institutional Ethics Committee) for organizing in a efficient manner to promote clinical trials.
• > Optimized data collection processes to enhance efficiency in data entry and analysis.
• > Optimized site performance metrics through continuous support and resources for clinical trial investigators.
• > Oversaw budgets and timelines to avert potential cost overruns and delays in study completion.
• > Analyzed patient records, databases, and physician referrals to select appropriate candidates for research studies.
• > Gather, analyze, and structure collected data.
• > Implemented informed consent protocols and upheld meticulous record-keeping.
• > Oversaw unit budget t o achieve financial objectives for spend rate and funding.

• Analyzed patient records, databases, and physician referrals to determine suitable candidates for research studies.
• Engaged in initiation visits and investigator meetings, executing trials aligned with study timelines and budgets.
• Ensured adherence to protocols governing patient care and clinical trial operations.
• Collaborated with the principal investigator and sponsors to streamline daily trial activities and ensure compliance with research protocols.
• Managed clinical trials emphasizing conditions such as oncology, hematology, gastroenterology, urology, nephrology, endocrinology, general medicine, ophthalmology, rheumatology, pulmonary medicine, and psychiatry.
• Collected, analyzed, and dispatched lab specimens.
• Executed informed consent processes and documented records.
• Compiled data in accordance with established research protocols, operations manuals, and case report form standards.
• Oversaw the quality assurance program, integrating on-site evaluations, internal audits, and customer surveys.
• Negotiated resolutions and achieved mutually beneficial agreements across the involved parties.
• Prioritized punctuality and upheld an exceptional attendance record, consistently arriving at work prepared for immediate engagement.
• Achieved an excellent attendance record through consistent punctuality.
• Fostered a positive working environment for research staff through regular team-building activities and ongoing professional development opportunities.

• Engaged with Pharmaceutical Sponsors and CRO partners to assess requirements and ensure prompt Clinical service provision.
• Implemented operational efficiencies yielding significant savings and enhanced profit margins.
• Negotiated resolutions and established cooperative agreements between conflicting parties.
• Upheld exemplary attendance record, reliably arriving on time for work.
• Troubleshot problems, streamlined operations, and facilitated superior client support.
• Orchestrated team communications and information sharing during meetings.
• Oversaw quality assurance program, encompassing on-site evaluations, internal audits, and customer surveys.
• Spearheaded data collection efforts by recruiting, training, and managing a team of research assistants to ensure accurate and timely results.

• Conducting clinical trials, clinical data management, ADR reporting, SAE reporting, and drug safety associate overseeing all aspects of the clinical trial process.
• Ensuring trials are conducted, recorded, and reported according to the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
• Conduct site identification and conduct feasibility studies.
• Keep a close association with the site for patient recruitment, patient follow-up, and protocol-related activities.
• Maintain accurate and timely correspondence and communication with the sponsor and site.
• Ensure the proper, essential documents are in place prior to the trial startup and on an ongoing basis throughout the study.
• Responsible for coordinating with the principal investigator, department, and central administrator to help ensure that clinical research and related activities are performed in accordance with ICH-GCP guidelines and sponsoring agency policies and procedures.
• Assists the principal investigator in the administration and oversight of clinical research and related activities.
• Area of Expertise

>Oncology.

>Immunology and rheumatology.

>Gastroenterology.

>Medicine.

>Pediatrics.

>Urology.

>Nephrology.

>Ophthalmology.

>Cardiology.

>Endocrinology.

>Neurology.

>Psychiatric science.

• Collaborated with pharmacy team members to develop and implement strategies for continuous improvement in quality of care.
• Managed high volume of prescriptions daily while maintaining excellent customer service and attention to detail.
• Conducted regular audits of the pharmacy's controlled substances inventory, ensuring accurate record-keeping and preventing diversion.
• Enhanced pharmacy efficiency by implementing new workflow processes and inventory management systems.
• Mentored pharmacy students and interns, contributing to development of future healthcare professionals.