Amita Rao
Research Fellow
Mumbai,MH
Summary
Dynamic professional with over 16 years of experience in Pharmaceutical Clinical Research Development and Operations, complemented by 3 years of freelance teaching in Clinical Research, Pharmacovigilance, and IPR Law. Expertise includes a deep understanding of technical and regulatory requirements from organizations such as the USFDA, EMEA, WHO, and ANVISA for Bioanalysis, Bioequivalence, Bioavailability Studies, and PK/PD studies. Proven ability to collaborate with cross-functional teams to develop project plans, manage resources and budgets, and ensure timely delivery of project objectives while identifying risks and implementing effective mitigation strategies. Successfully designed comprehensive online courses on platforms like Udemy, focusing on advanced clinical research fundamentals and strategies for aspiring Clinical Research Associates.
Overview
16
16
years of professional experience
12
12
Certifications
3
3
Languages
12
12
years of post-secondary education
Work History
Research Fellow
P.D. Hinduja Hospital & MRC
10.2024 - Current
- Performing multitasking activities in various Clinical departments like Medical Writing, Clinical Data analysis, Clinical Research training, AI Implementation.
- Therapeutic areas: Neurology, AI in nursing care, Dermatology, Infectious diseases.
Data Surveillance Analyst
Parexel Research Pvt. Ltd.
11.2021 - 05.2023
- Played an integral role in RBQM/Department Support by actively engaging in cross-functional meetings, initiatives, and comprehensive metrics reporting.
- Actively participated in Business Development/Sponsor Support endeavors by contributing to data surveillance process presentations, conducting DS technologies demonstrations, and delivering insightful DS findings/presentations.
- Provided valuable assistance in crafting Data Surveillance Plan, inclusive of Key Risk Indicators, Quality Tolerance Limits & cutting-edge Data Surveillance Technologies.
- Conducted thorough reviews of relevant data using sophisticated platforms such as the Data Surveillance Application, CluePoints, DDM Application, and other pertinent reports and systems.
- Diligently documented findings from Data Surveillance activities in meticulously maintained tracking systems like the DS Findings & Actions Log, CluePoints Signals & Actions Tracker, and other specified repositories.
- Actively participated in routine Data Surveillance meetings, communicating findings from diverse reviews to key cross-functional leads on the project.
- Collaborated closely with Technology Teams to identify innovative solutions that seamlessly aligned with Parexel’s overarching business and technology strategy.
- Identified and meticulously evaluated potential data quality issues to ensure steadfast adherence to established standards.
- Defined and executed precise follow-up actions in collaboration with relevant stakeholders or as directed by guidance.
- Actively engaged in both external and internal meetings, audits, and regulatory inspections as necessitated by project requirements.
- Promptly recognized and escalated any instances of study non-compliance, issues, delays, or data quality signals to the Functional Lead for immediate action.
- Therapeutic areas: Restless leg syndrome, Breast cancer, Chron’s disease, Melanoma study, Amyloidosis, Thalassemia, Non-alcoholic steatohepatitis(NASH), Parkinson’s disease.
Legal & Administrative Officer
Welsun Chemicals Pvt. Ltd.
07.2021 - 10.2021
- Managed legal documentation and administrative tasks efficiently.
- Managed legal documentation & administrative tasks, ensuring compliance with legal regulations and company policies.
Medical Surveillance Specialist 1
IQVIA
04.2017 - 06.2021
- Monitored and evaluated laboratory results daily from the sponsor-designated central laboratory.
- Conducted preliminary reviews of laboratory results based on established protocol-specific reference range guidelines.
- Applied relevant clinical laboratory experience to compare current results with prior laboratory values, identifying clinically significant increases/decreases and contacting investigator sites for additional clinical context as needed for distribution to the Project Team.
- Acted as a liaison between the Medical Services Department, sponsor-designated laboratory, and the IQVIA Project Team.
- Established new projects using project-specific procedures in collaboration with Sponsor/IQVIA Medical Advisors, Central Laboratory Project Manager, and IQVIA Clinical Project Manager.
- Ensured that project setup aligned with protocol objectives and maintained the integrity of laboratory support services.
- Participated in investigator/study start-up meetings, delivering Medical Laboratory Surveillance presentations as requested by the Sponsor or project manager.
- Represented the Medical Services Team at client meetings, project team meetings, and investigator meetings.
- Maintained up-to-date laboratory knowledge through continuing education activities and attending medical seminars.
- Identified potentially significant trends or shifts in laboratory results, alerting IQVIA Medical Advisors based on clinical laboratory and monitoring experience.
- Interacted with the Project Team to convey critical information that could impact study objectives.
- Collaborated with central laboratory staff to facilitate appropriate monitoring and reporting of subject laboratory results.
- Managed the daily archival of documents such as daily review reports and final emails in eTMF.
- Utilized platforms like Elvis, Veeva Vault, and Wingspan for document management.
- Created folders in eTMF and provided training to the team on Veeva Vault and Elvis archival.
- Prepared various PowerPoint presentations on Veeva Vault training, including tasks such as uploading emails and completing assigned tasks.
- Archived emails in Elvis DIA for subsequent transfer by RIM staff to Veeva.
- Therapeutics areas: Breast cancer, malignant tumor of brain, Non-Hodgkin Lymphoma, Hemophilia, Ulcerative Colitis, Major depressive disorder, Hypertriglyceridemia, Hypersomnia, Chron’s disease, Pulmonary Fibrosis, Gastrointestinal cancer, Meningitis
Clinical Research Associate
Anazeal Analytical Research Pvt. Ltd.
10.2013 - 07.2016
- Identified and evaluated potential sites suitable for conducting clinical trials.
- Collaborated closely with doctors, consultants, and investigators to facilitate the smooth running of trials.
- Oversaw the setup of trial sites, ensuring adequate provision of all necessary trial materials, including the investigational medicinal product (IMP).
- Negotiated study budgets with Principal Investigators to ensure alignment with project objectives.
- Drafted essential trial documentation such as informed consent forms (ICFs), case report forms (CRFs), and Investigators Brochures.
- Ensured meticulous management of investigational product (IP) shipment records and storage facilities, conducted IP accountability checks, verified source data, identified any discrepancies between CRFs and source data, and coordinated the delivery of trial supplies to sites.
- Conducted comprehensive study close-out visits, meticulously archived study files, and provided effective training and mentorship to incoming personnel.
Legal Assistant
Adv. Dinesh Rao & Associates
11.2011 - 09.2013
- Legal drafting in various domains including medicolegal and IPR cases
Clinical Research Coordinator
P.D. Hinduja Hospital
06.2010 - 10.2011
- Directed the drug dispensing, maintained patient and investigational product (IP) accountability logs, completed case report forms (CRFs), oversaw sample collection and processing, conducted clinical investigations such as electrocardiograms (ECGs), pulse measurements, temperature monitoring, and receipt of IP shipments.
- Coordinated with the Ethics Committee to ensure the protection of the rights, safety, and well-being of all trial subjects.
- Managed regulatory authority applications and approvals related to the monitoring and marketing of new and existing drugs.
Education
Mastery Program - AI & ML
Be10X
04.2025 - 01.2026
Diploma - Pharmacovigilance
Academy of Clinical Excellence
03.2020 - 03.2021
LLB - Medicine & IPR
New Law College, Mumbai University
06.2013 - 04.2016
MBA - Healthcare Services
Sikkim Manipal University
07.2011 - 11.2013
M.Sc. - Animal Physiology
D.G. Ruparel College, Mumbai University
06.2006 - 10.2009
P.G. Diploma - Clinical Research
ICRI, Cranfield University
10.2007 - 11.2008
B.Sc. - Zoology
Kirti College, Mumbai University
06.2003 - 04.2004
Skills
Clinical Research & Operations, Pharmacovigilance, AI in Healthcare, Clinical data analysis, Medical writing, Medical Surveillance, Legal advisor
Accomplishments
I have developed couple of AI tools such as Stroke prevention app, Fall prevention app, Hospital bed resource allocation tool, RAG, Healthcare LLM tool, CT scan reading app, X-Ray reading app, ECG reading tool, Copywriting app, Document insight extraction tool, DNA sequence prediction tool, created some sample Websites for Healthcare, etc.
Certification
Completed Workshop on AI &ML from Be10X
AWARDS
Chron’s Disease Study 2023, Melanoma Study 2023, Breast Cancer Study, 2022, Idiopathic Hypersomnia Study 2021, Hypertriglyceridemia Study, 2018
Timeline
Mastery Program - AI & ML
Be10X
04.2025 - 01.2026
Research Fellow
P.D. Hinduja Hospital & MRC
10.2024 - Current
Data Surveillance Analyst
Parexel Research Pvt. Ltd.
11.2021 - 05.2023
Legal & Administrative Officer
Welsun Chemicals Pvt. Ltd.
07.2021 - 10.2021
Diploma - Pharmacovigilance
Academy of Clinical Excellence
03.2020 - 03.2021
Medical Surveillance Specialist 1
IQVIA
04.2017 - 06.2021
Clinical Research Associate
Anazeal Analytical Research Pvt. Ltd.
10.2013 - 07.2016
LLB - Medicine & IPR
New Law College, Mumbai University
06.2013 - 04.2016
Legal Assistant
Adv. Dinesh Rao & Associates
11.2011 - 09.2013
MBA - Healthcare Services
Sikkim Manipal University
07.2011 - 11.2013
Clinical Research Coordinator
P.D. Hinduja Hospital
06.2010 - 10.2011
P.G. Diploma - Clinical Research
ICRI, Cranfield University
10.2007 - 11.2008
M.Sc. - Animal Physiology
D.G. Ruparel College, Mumbai University
06.2006 - 10.2009
B.Sc. - Zoology
Kirti College, Mumbai University
06.2003 - 04.2004