Akshay Bhati
Bengaluru
Summary
I am a dedicated clinical research professional with over four years of experience in clinical research and clinical project management, where I worked on different stages of clinical studies and project management (CTMS – Zavacor). Proven track record of successfully managing multiple studies, ensuring compliance with regulatory requirements.
Overview
5
5
years of professional experience
Work History
Senior Clinical Database Setup Coordinator
LabCorp Drug Development Pvt. Ltd.
Bengaluru
09.2024 - Current
- Performed effective multitasking and played the role of trainer, workload dealer, quality reviewer, mentor, and standard operating procedure (SOP) reviewer as per the business requirements.
- Planned employee workloads and delegated tasks strategically to meet seasonal fluctuations in demand.
- To critically review CRFs, SOWs, and CILs as specified in the data management plan, and to query any errors or omissions with either the Global Study Manager, Study Design Lead, or Clinical Database Designer as necessary.
- Ensure that the TAT (turnaround time) of the projects is consistently maintained at 99% and above.
- Utilized data visualization tools (Power BI) to effectively communicate business insights.
Clinical Database Setup Coordinator
LabCorp Drug Development Pvt. Ltd.
Bengaluru
06.2021 - 08.2024
- To action all tasks related to clinical data management study setup in the database (i.e., Zavacor) from the start (i.e., new loads to handle modification requests as the study commences until the completion of a study).
- Collaborated with cross-functional teams to identify data sources and streamline data collection, resulting in a significant reduction in report development time.
- To track and resolve data clarification forms in the study-specific database.
- To resolve the quality control of data and CRFs, as appropriate.
- Monitored project progress and provided updates to stakeholders.
Project Assistant
Department of Clinical Research, Narayana Health
Bengaluru
05.2020 - 06.2021
- Co-author of professional scientific papers for publication in peer-reviewed journals.
- Preparation of project-related reports, manuscripts, and presentations.
- Experienced in designing informed consent forms. I also have experience in the informed consent process and communication with patients.
- Recruited many patients to evaluate their responses and medical files for several studies.
- Experience in capturing patients' data relevant to the study in the paper and e-CRF.
- Performed statistical analysis of several studies.
Education
Master of Science - clinical research
Rajiv Gandhi University of Health Sciences
Bengaluru, Karnataka05-2020
Bachelor of Science - zoology
Mohanlal Sukhadia University
Udaipur, Rajasthan03-2018
Skills
- Good comprehension of ICH-GCP guidelines
- Good Clinical Practice certified
- Electronic data capture
- Clinical trial management
- Medical writing experience
- Good knowledge about study documents
- Project management
- Microsoft Office and Power BI
Publications
- Online Fellowship Exit Examination During the COVID-19 Pandemic, Muralidhar Kanchi, Poonam Malhotra, Kirubanand Senniappan, Ajith Kumar, Radha Krishnan, Soumi Das, Akshay Bhati, Kumar Belani, Global Bioethics Journal - UNESCO, 2207-7723
- Off-pump technique may prevent the worsening of renal function in CAD patients with CKD undergoing coronary artery bypass grafting, Shaheen Afsal, Sujani Kola, Manaswini Keshav, Shashank Viswanathan, Akshay Bhati, Harish Bandlapally, Muralidhar Kanchi, J Card Crit Care, 2021, 00:1–5, 2457-0206
Projects
- Investigation of genetic factors predisposing individuals to acute kidney injury (AKI) and discovery of potential biomarkers of AKI in patients undergoing off-pump coronary artery bypass grafting (OP-CABG)
- U-Tru signal study
- Prostate quantification study
- A retrospective study for the development of a multi-marker test for the prediction of the risk of platinum drug resistance to aid in effective therapy planning in patients with high-grade ovarian carcinoma
- Prevalence of perceived stress and its association with metabolic parameters among individuals undergoing a master health check-up: A cross-sectional study
Timeline
Senior Clinical Database Setup Coordinator
LabCorp Drug Development Pvt. Ltd.
09.2024 - Current
Clinical Database Setup Coordinator
LabCorp Drug Development Pvt. Ltd.
06.2021 - 08.2024
Project Assistant
Department of Clinical Research, Narayana Health
05.2020 - 06.2021
Master of Science - clinical research
Rajiv Gandhi University of Health Sciences
Bachelor of Science - zoology
Mohanlal Sukhadia University
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