BHAVNA DARYANI
Milpitas,USA
Summary
Dynamic clinical research operations leader with robust background in overseeing large-scale programs and improving operational efficiency. Known for delivering impactful process improvements and fostering strong team collaboration. Highly adaptable to changing needs and proficient in strategic planning and project management.
Overview
15
15
years of professional experience
Work History
Lead Clinical Research Operations Program Manager
Google
Mountain View, California
10.2021 - Current
- Manage a team of Clinical Research Associates.
- Designed, managed, and executed the designated clinical studies including FDA validation trials.
- Design and develop protocols, informed consent forms (ICFs), case report forms (CRFs), enrollment plans, schedules, and other study-related documents to ensure regulatory compliance and effective study execution.
- Manage IRB communications and submissions for protocols and amendments, ensuring timely approvals and adherence to regulatory standards.
- Collaborate and Partner with external CROs and vendors to carry out efficient and fully compliant research trials.
- Conduct site qualification and monitoring to assess site performance and compliance, delivering detailed reports and correspondence to management.
- Lead process improvement and development, including SOP development, training, and process mapping.
- Participate in process improvement and development: SOP development, training, process mapping, and other departmental activities.
- Authored and reviewed manuscript submissions for health sciences journals.
CLINICAL RESEARCH OPERATIONS SPECIALIST
Akorbi Workforce Solutions
Palo Alto, California
10.2019 - 10.2021
- Designed research studies and developed protocols, informed consent forms, and case report forms in collaboration with project teams to ensure effective trial execution.
- Designed research studies and developed protocols/ICFs/CRFs in collaboration with project teams.
- Managed IRB communications and submissions for protocols and amendments, ensuring adherence to regulatory standards and facilitating timely approvals.
- Ensured data quality control and conducted thorough data analysis to support accurate trial outcomes.
- Created and maintained trial master files to uphold regulatory compliance.
- Oversaw shipment delivery and receipt of clinical study materials, ensuring accountability and integrity of devices throughout the trial.
CLINICAL ASSISTANT
About Smile Dental
San Jose, California
03.2018 - 01.2019
- Oversaw quality assurance program through on-site evaluations, internal audits, and patient surveys, ensuring compliance and enhancing patient satisfaction.
- Served as liaison between office, laboratories, and insurance companies including Delta Dental and Cigna to streamline communication and processes.
- Created data collection and monitoring mechanisms using Dentrix software to enhance dental care.
- Acted as liaison between office, laboratories, and insurance companies like Delta Dental and Cigna.
- Managed clinical inventory and supplies order shipments, contributing to operational improvements.
DENTAL SURGEON
Sewa Sadan Eye Hospital Trust
India
02.2013 - 10.2014
- Performed dental procedures including scaling, root canals, prosthodontics, extractions, and radiology to address patient needs.
- Oversaw operating room activities with local anesthesia, maintaining compliance with safety protocols to ensure patient safety.
- Collaborated with laboratories and surgeons to devise comprehensive treatment plans.
- Mentored and trained dental assistants and interns, fostering skill development and knowledge retention.
- Coordinated dental camps in schools and rural areas to deliver accessible dental care.
INTERN
Mansarovar Dental College
India
01.2012 - 12.2012
- Executed dental procedures including root canals, cavity fillings, and tooth extractions, guiding patients on pain management techniques to minimize discomfort.
- Achieved Best Dental Intern Certificate for outstanding performance during internship.
- Coordinated boot camps and dental conventions, increasing community engagement and awareness of dental health practices.
Education
Bachelors Of Dental Surgery -
MANSAROVAR DENTAL COLLEGE
IndiaClinical Trials Design And Management
UCSC Silicon Valley
Santa Clara, CASkills
- Clinical data management
- Study design
- Protocol development
- Regulatory compliance
- GCP compliance
- Clinical trial standards
- Data analysis
- Electronic data capture
- Clinical trial software
- Project management tools
- Clinical research terminology
- Team leadership
- Collaboration skills
- Organizational skills
- Critical thinking
Accomplishments
- GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) (CITI)
- Biomedical Research (CITI)
- Public Health Research (CITI)
- Responsible Conduct of Research (CITI)
- HIPAA
- Veeva Vault certification
Awards and Honors
- Authored “SymptomAI: Toward a Conversational AI Agent for Everyday Symptom Assessment” published in arXiv.
- Authored "Opportunistically Detecting Signs of Hypertension on a Consumer Smartwatch," published in Nature.
- Authored "Assessment of Asthma Severity Using Remote Sensors," published in the Journal of Allergy and Clinical Immunology (JACI).
- Spearheaded the research study "Body Temperature Software" for the Google Pixel ecosystem - FDA approved (De Novo).
- Acknowledged in the “Prospective validation of smartphone-based heart rate and respiratory rate measurement algorithms” published in Nature.
- Acknowledged in the research study of “Research into how AI can help users understand skin conditions”
- Co-authored "Sleep-wake Detection With a Contactless, Bedside Radar Sleep Sensing System," focusing on non-invasive monitoring.
- Validated smartphone-based heart and respiratory rate algorithms in the prospective study published via medRxiv.
- Recognized for contributions to the Federated Learning manuscript published by Google in npj Digital Medicine and medRxiv.
- Published "Dental World" presentation in the official journal of the Indian Dental Association (IDA).
Timeline
Lead Clinical Research Operations Program Manager
Google
10.2021 - Current
CLINICAL RESEARCH OPERATIONS SPECIALIST
Akorbi Workforce Solutions
10.2019 - 10.2021
CLINICAL ASSISTANT
About Smile Dental
03.2018 - 01.2019
DENTAL SURGEON
Sewa Sadan Eye Hospital Trust
02.2013 - 10.2014
INTERN
Mansarovar Dental College
01.2012 - 12.2012
Clinical Trials Design And Management
UCSC Silicon Valley
Bachelors Of Dental Surgery -
MANSAROVAR DENTAL COLLEGE