Hemangi Dhole- Epidemiologist/ Research Scientist
USA
Summary
Experienced Clinical Research Professional with over a decade of expertise in managing complex clinical trials across therapeutic areas including oncology, cardiology, gastroenterology, and neurology. Skilled in cross-functional leadership, strategic planning, regulatory compliance (FDA, ICH, GCP), and stakeholder collaboration. Proven ability to manage budgets, lead multi-site studies, and ensure operational excellence. Seeking to leverage extensive experience into a Clinical Research Leadership position.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Epidemiologist/Research Scientist
IM-Digestive & Liver Diseases
06.2024 - Current
- Review proposed new research studies and determine projects to implement; negotiate budget and contract issues; initiate regulatory activities; oversee preparation of necessary project summaries, consent forms, etc.
- Act as Principle investigator and oversee statisticians, healthcare providers, and technology developers. Manage relationships with Institutional Review Boards (IRBs) and other external resources.
- Provide mentorship and guidance to clinical research professionals, residents, and fellows, fostering a supportive environment that promotes growth and excellence.
- Provide support with grant writing and submissions
- Oversee on-going research grants and studies, negotiate favorable agreements with laboratories and collaborators on campus; monitor profitability of research studies; renegotiating contracts, supplements, etc. as needed
- Direct financial oversight and management of clinical research unit; Actively participate in the selection process of clinical research unit staff; provide training in research, financial, laboratory, and evaluates staff performance and implements
- Identify potential sponsors for clinical research unit; develop and oversee marketing strategies.
- Work with external statistical analysts to analyze data, develop charts, tables, and references, and ensure precise data recording and reporting
- Initiate and maintain collaborative relationships between clinical research unit and basic science facilities
- Design, execute, and maintain an effective system of internal controls which provides reasonable assurance that operations are effective and efficient, assets are safeguarded, and financial information is reliable
- Ensure compliance with applicable laws, regulations, policies, and procedures
- Analyzed complex data sets using statistical software to identify disease trends using SAS and SPSS
- Collaborated with multidisciplinary teams to develop comprehensive public health solutions for disease outbreaks.
- Secured funding for epidemiological research projects by writing successful grant proposals and presenting findings to stakeholders.
- Maintained data, reporting and quality assurance standards throughout investigations.
- Developed and implemented epidemiological studies to assess public health concerns.
Epidemiology Program Director
UT Southwestern Medical Center
02.2022 - 06.2024
- Lead multi-site randomized controlled research study, orchestrating collaboration, and logistical operations across diverse locations
- Oversee monitoring of Institutional Review Board (IRB) submissions and promptly address inquiries and requests
- Engaged in creation and refinement of various study-related materials, including Clinical Monitoring Plans, Data Management Plans, eCRF forms, completion guidelines, protocols, initial drafts of patient informed consent documents, site instructions for specimen collections, and the approval process for sites to receive the investigational study drug
- Lead and guide cross-functional teams to ensure timely and high-quality execution of clinical trial
- Manage regulatory compliance, including regulatory activities, project summaries, TMFs, IRB submissions, annual updates, and database maintenance
- Developed innovative social media marketing strategies to boost research study participation
- Planned, designed, and scheduled phases for large projects.
- Developed comprehensive project plans with clear timelines, milestones, and budget requirements, ensuring timely delivery of high-quality results.
- Developed strong relationships with internal and External stakeholders through regular communication updates, fostering trust and confidence in the team’s ability to deliver results.
- Collaborated closely with senior management to align project objectives with strategic company initiatives, ensuring that efforts contributed to overall business growth.
- Monitored project performance to identify areas of improvement and adjust.
- Coordinated cross-functional teams and resolved conflicts, maintaining a positive work environment throughout the project lifecycle.
- Provided detailed project status updates to stakeholders and executive management.
- Mentored junior team members in project management best practices to enhance their skills and contribute to better overall performance.
- Improved stakeholder satisfaction with detailed project updates and proactive issue resolution.
- Developed statistical models to enhance predictive analytics capabilities across various projects using SAS, SPSS and R programming.
Senior Manager - Research and Development
UT Southwestern Medical Center
12.2020 - 02.2022
- Monitored progress against project timelines, ensuring timely completion of deliverables while maintaining high-quality standards.
- Set up equipment, organized inventory and maintained facilities.
- Provided technical guidance on experimental design and data interpretation issues for team members as needed.
- Gathered, arranged, and corrected research data to create representative graphs and charts highlighting results for presentations.
- Validated incoming data to check information accuracy and integrity while independently locating and correcting concerns.
- Assisted in the development of new research proposals, resulting in increased funding opportunities and project growth potential.
- Conducted comprehensive literature reviews to inform study designs and methodology decisions.
- Helped team meet regulatory requirements by coordinating documentation and filings.
- Collaborated with multidisciplinary teams to drive project success and achieve objectives.
- Implemented standardized documentation practices across the team to enable easier collaboration between researchers.
- Presented research findings at industry conferences, increasing visibility for the organization.
- Distilled large amounts of information and produced reports, spreadsheets, and documents outlining key details.
- Supported stakeholder engagement efforts through regular communication of research updates and findings.
- Gathered and organized information for research purposes.
- Analyzed complex datasets using SAS to identify trends and inform team decisions.
- Created Statistical Analysis Plan (SAP) to help other research understand the study analysis.
- Created visualizations and dashboards to present findings to stakeholders effectively.
- Streamlined data collection processes, reducing time spent on manual reporting tasks significantly.
Associate Manager- Global Regulatory Affairs
Abbott Healthcare Pt. Ltd
06.2015 - 01.2018
- Led strategic project planning and execution in Cardio-metabolites, Women’s health, and Depression therapeutic areas
- Managed clinical studies and addressed health authorities’ deficiency letters and queries
- Maintained and reviewed clinical dossiers, participated in cross-functional teams, and ensured compliance with global regulatory guidelines
- Reviewed and approved promotional materials and ensured trial safety compliance
- Represented the team globally, traveled to various Abbott locations for strategic discussions, and managed budgets
- Participate and contribute to discussions within cross-functional teams
- Schedule & attend meetings, draft agendas, maintain minutes of meeting, send calendar invites, manage timelines
- Working with Product Leads and SMEs, develops strategic responses, within cross-functional team
- Reviewing and evaluating new guidelines/policy (e.g., WHO, FDA, EU) and determining implications for company documents/labelling of therapeutic area products
- Work periodically on compliance checks, audits, risk management plans
- Coordinating review and approval of documents, considering changing global regulatory environment
- Successfully managed multiple high-priority tasks simultaneously while maintaining strict deadlines ensuring optimal resource allocation.
- Established strong relationships with key stakeholders, fostering collaboration and mutual support.
- Managed cross-functional projects, ensuring timely completion and alignment with company objectives.
- Mentored junior team members, contributing to their professional growth and skill development.
- Enhanced team productivity by implementing efficient project management strategies.
Clinical Data Manager
Cognizant Technology Solutions
03.2014 - 05.2015
- Support Clinical site staff, coordinate with site staff and research assistants, Assist PI’s and site monitors
- Documented adverse events (AE) and serious adverse events (SAE), tracked project status and timelines
- Review informed consents, verify subject recruitment based on inclusion/exclusion criteria
- Reduced data discrepancies through the implementation of robust validation checks and error resolution procedures.
- Led a team of data management specialists to ensure timely completion of project deliverables.
- Managed the transition to electronic data capture systems, resulting in increased productivity and reduced manual errors.
- Collaborated with cross-functional teams to drive the successful execution of clinical trials.
- Participated in internal audits as well as inspections conducted by regulatory agencies, demonstrating compliance with industry standards.
- Conducted ongoing assessments of data quality throughout the course of each trial, addressing any issues promptly and effectively.
- Developed and maintained comprehensive data management plans, ensuring compliance with regulatory requirements.
- Participated in committees to discuss electronic health records and methods to improve overall workflows.
- Created data management plans and provided input on study designs.
- Applications: MEDIDATA RAVE 5.6.4, J-Review
- Developed and maintained software applications using Python and JavaScript frameworks.
- Created predictive analysis to track the business growth
Lead Clinical Data Manager
TATA Consultancy Services
05.2012 - 03.2014
- Led data management efforts, including protocol development, subject recruitment, and IRB submissions
- Experienced in Oncology Data Management
- Conducted data entry and analysis on EDC, managed eCRF design, and performed discrepancy management
- Oversaw data reconciliation and system updates, ensuring regulatory compliance
- Data entry and analysis on EDC
- ECRF designing
- Extraction and reconciliation of large datasets (IVRS, PK/PD), performing cross module data reconciliations
- Identifying new system updates, reviewing standard documents and determine its impact on study
Education
Master of Public Health - Public Health, Epidemiology
The University of Texas at Arlington
Arlington, TX05.2022
Masters - clinical research & Regulatory Affairs
Sikkim Manipal University
Mumbai05.2015
Post-Graduate Certificate - Pharmaceutical Management
University of Mumbai
Mumbai08.2011
Bachelor of Science - Biotechnology
University of Mumbai
Mumbai07.2010
Skills
- Research Scientist
- Regulatory Compliance
- Multi-site Trial Execution
- Institutional Review Board (IRB) management
- Project Planning & Risk Management
- Budgeting & Financial Oversight
- Cross-functional Team Leadership
- Stakeholder Engagement
- Grant Writing & Funding Strategy
- Data Monitoring & Auditing
- Tools: MS Project, J-Review, MEDIDATA Rave, eCRF, EHR Systems, SAS, SPSS, STATA, R programing, ArcGIS, E-clinical works, EPIC,
- Grant writing
- Epidemiological research
- Data analysis
- Statistical modeling
- Chronic Disease Investigation
- Infectious Disease Investigation
Certification
- ICH GCP
- HSP
- HIPAA
- IATA
Timeline
Epidemiologist/Research Scientist
IM-Digestive & Liver Diseases
06.2024 - Current
Epidemiology Program Director
UT Southwestern Medical Center
02.2022 - 06.2024
Senior Manager - Research and Development
UT Southwestern Medical Center
12.2020 - 02.2022
Associate Manager- Global Regulatory Affairs
Abbott Healthcare Pt. Ltd
06.2015 - 01.2018
Clinical Data Manager
Cognizant Technology Solutions
03.2014 - 05.2015
Lead Clinical Data Manager
TATA Consultancy Services
05.2012 - 03.2014
Post-Graduate Certificate - Pharmaceutical Management
University of Mumbai
Bachelor of Science - Biotechnology
University of Mumbai
Master of Public Health - Public Health, Epidemiology
The University of Texas at Arlington
Masters - clinical research & Regulatory Affairs
Sikkim Manipal University
PUBLICATIONS
- Tarrant County Retail Food Environment – Dec 2020
- The Implications of Artificial Intelligence in Dentistry
Softwares
SAS=
SPSS
R
STATA
EPIC