Divya Bhadran
Kochi
Summary
Clinical Data Specialist with extensive experience in developing and implementing data management protocols, ensuring compliance with regulatory standards while enhancing data integrity. Successfully collaborated with cross-functional teams to streamline data collection processes, resulting in improved efficiency and accuracy during clinical trials. Conducted thorough data validation and cleaning activities, which led to higher quality datasets for clinical analysis and reporting. Engaged in regular audits of clinical data systems, identifying discrepancies and ensuring adherence to Good Clinical Practice (GCP).
Overview
10
10
years of professional experience
Work History
Clinical Data Specialist
IQVIA
Kochi
08.2025 - Current
- Led the development and implementation of data management protocols, ensuring compliance with regulatory standards and improving data integrity.
- Collaborated with cross-functional teams to streamline data collection processes, enhancing efficiency and accuracy in clinical trials.
- Conducted data validation and cleaning activities, resulting in improved quality of datasets used for clinical analysis and reporting.
- Developed comprehensive reports summarizing clinical trial outcomes, facilitating effective communication of results to stakeholders.
- Implemented process improvements that optimized data entry workflows, reducing turnaround time for critical project deliverables.
- Engaged in regular audits of clinical data systems, identifying discrepancies and ensuring adherence to Good Clinical Practice (GCP).
- Updated project documentation including study protocols, monitoring plans.
- Participated in user acceptance testing for new versions of clinical trial software applications.
- Provided technical support to end users on clinical database applications.
- Generated customized reports from CDMS based on sponsor requests.
- Analyzed complex datasets to identify trends or patterns in the data.
- Developed standard operating procedures related to clinical data management activities.
- Provided guidance and mentorship to junior team members.
- Identified discrepancies between collected data and original source documents; resolved issues by working with investigators or other staff members.
- Performed data validation tasks to ensure accuracy and completeness of clinical trial data.
- Prepared periodic reports summarizing study progress and outcomes.
- Compiled data to enter necessary information into appropriate databases.
- Developed procedures for organizing and filing clinical data to enhance workflow efficiency.
- Analyzed clinical data using statistical tools to identify informational trends.
- Followed standard operating procedures to perform quality control audits.
- Increased productivity and efficiency by regularly reevaluating processes and technologies.
- Adjusted data into necessary formats by using categorization and classification software.
Clinical Data Analyst
Fortrea
Bangalore
08.2021 - 08.2025
- Analyzed clinical trial data to ensure compliance with regulatory standards, enhancing data integrity and reliability.
- Developed and maintained comprehensive data management systems, streamlining processes for efficient data retrieval and reporting.
- Collaborated with cross-functional teams to design data collection tools, improving accuracy and consistency in patient data.
- Complete required trainings according to timelines
- Within the specified timelines review and action, queries on an ongoing basis and upon meeting the quality expectations update database appropriately, as assigned
- Work as per assigned Data Management related operational data flows
- Review reports and take actions as defined in the DMP or eCRF review manual, as assigned
- Perform ongoing and final consistency checks, data listings review as defined in the DMP and eCRF
- Review Manual, as assigned
- Ensure that all Data Management activities are conducted in compliance with relevant regulatory requirements and Good Clinical Practices
- Setup and maintenance of EDC User Access Accounts for databases
- Ensure EDC user requests for database access are completed accurately and efficiently
- Troubleshoot and correct User access issues; follow up with EDC vendor for technical support as needed
- Create, format and distribute User Access Report to Project Managers/Lead Data Manager for reconciliation of User access
Dentist
HCL AVITAS
07.2019 - 08.2020
- Examining, diagnosing and treating oral health problems.
- Treatments like oral prophylaxis, restoration, extractions, crown preparation and educating patients.
- Conducting camps in offices, school and spreading awareness of oral health and anti-smoking.
Dentist
VASAN DENTAL CARE
08.2017 - 06.2019
- Examining, diagnosing and treating oral health problems.
- Treatments like oral prophylaxis, restoration, extractions, crown preparation and educating patients.
- Conducting camps in offices, school and spreading awareness of oral health.
Junior Resident
Charak Palika hospital
New Delhi
04.2016 - 03.2017
- Dental resident examining oral health issues, diagnosing and treating oral problems.
- Creating awareness among patients related to oral problems and importance of treatment.
Education
PG Diploma - Clinical Research & Pharmacovigilance
Bachelor of Dental Surgery -
KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES
Basic SAS Programming -
SAS INDIA
Skills
- ICMR Guidelines
- Indian GCP schedule Y
- Phases of Clinical Trials
- Drug Discovery and Development Process
- Principles of ICH GCP
- Indian and US FDA regulations
- CRF Design
- Ethics in Clinical Research
- Bio availability and bio equivalence study and guidelines
- Responsibilities of sponsor
- Sponsor Investigator Responsibilities
- Sponsor Vendor Responsibilities
- Site visit
- Site initiation
- NDA
- Essential documents
- IND application
- Consent form
- Electronic signature
- Data tracking of CRFs
- Data management plan
- Electronic Data Capture
- Data collection
- Data entry
- Data validation
- Knowledge of Pharmacovigilance
- Basic Knowledge of Human Anatomy & Physiology
- Knowledge of Dentistry
- Good Knowledge of Clinical Practice & protocols
- Knowledge of Human Disease / Diagnosis & Treatments
- Adaptable
- Collaborative with team
- Self-driven
- Honest
- Hard-working
- Problem solving skills
- Enthusiastic
- Quick witted
Accomplishments
- Maintained decent academic record consistently.
- University 7th Rank holder in Oral medicine and Radiology.
Clinical Research Knowledge
- ICMR Guidelines
- Indian GCP schedule Y
- Phases of Clinical Trials
- Drug Discovery and Development Process & Principles of ICH GCP
- Comprehensive knowledge about Indian and US FDA regulations.
- CRF Design
- Ethics in Clinical Research
- Bio availability and bio equivalence study and guidelines
- Responsibilities of sponsor, SI
- Sponsor Investigator Responsibilities
- Sponsor Vendor Responsibilities
- Site visit
- Site initiation
- NDA
- Essential documents
- IND application
- Consent form
- Electronic signature
Clinical Data Management Knowledge
- Data tracking of CRFs
- Data management plan
- Electronic Data Capture
- Data collection
- Data entry and Data validation
References
References available upon request.
Extracurricular Activities
Participated in health awareness camps Winner of poster designing competition conducted by Public health Dept. & Rajiv Gandhi University on Oral Hygiene day 2015.
Disclaimer
I hereby declare that the information furnished in this document is true to the best of my knowledge.
Area Of Expertise
- Knowledge of Pharmacovigilance
- Basic Knowledge of Human Anatomy & Physiology
- Knowledge of Dentistry
- Good Knowledge of Clinical Practice & protocols
- Knowledge of Human Disease / Diagnosis & Treatments
Areas Of Interest
- Clinical Research
- Pharmacovigilance
Languages
English
Advanced
C1
Hindi
Upper Intermediate
B2
Malayalam
Upper Intermediate
B2
Timeline
Clinical Data Specialist
IQVIA
08.2025 - Current
Clinical Data Analyst
Fortrea
08.2021 - 08.2025
Dentist
HCL AVITAS
07.2019 - 08.2020
Dentist
VASAN DENTAL CARE
08.2017 - 06.2019
Junior Resident
Charak Palika hospital
04.2016 - 03.2017
PG Diploma - Clinical Research & Pharmacovigilance
Bachelor of Dental Surgery -
KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES
Basic SAS Programming -
SAS INDIA