Neha Savant
Team Lead - Clinical Reviewer
Summary
Detail-oriented and highly analytical Clinical Reviewer and Research Associate with 4 years of experience in reviewing clinical data, ensuring regulatory compliance, and supporting medical research projects. Proven ability to evaluate clinical documentation, identify discrepancies, and collaborate effectively with cross-functional teams to uphold data integrity and research quality. Skilled in literature review, protocol development, data analysis, and regulatory reporting. Committed to advancing clinical outcomes through accuracy, precision, and evidence-based research practices.
Overview
6
6
years of professional experience
Work History
Team Lead - Clinical Reviewer
Gravita Oasis Review Solutions Private Limited
03.2022 - 06.2024
- Enhanced overall team performance by providing regular coaching, feedback, and skill development opportunities.
- Educated team members on organizational mission and goals to enhance alignment and drive success.
- Completed detailed documentation for each case reviewed, ensuring clarity for future reference and potential audits.
- Used medical and clinical review guidelines and parameters to maintain consistency in MD review process, appropriate utilization levels and compliance with facility policies and procedures.
- Established clear performance metrics for the team which helped in tracking progress towards set targets effectively.
- Coached team members in techniques necessary to complete job tasks.
- Evaluated employee skills and knowledge regularly, training, and mentoring individuals with lagging skills.
- Maintained database systems to track and analyze operational data.
Research Associate (QC Auditor)
ACCUTEST RESEARCH LABORATORIES
10.2018 - 10.2020
- To perform quality checks in clinical phase.
- To perform in process and retrospective quality checks in clinical department.
- Retrospective quality checking of study documents (Screening form, CRF,TMF).
- To perform quality checks in different in-process activities like screening, ICF presentation, checkin, dosing, vital examination, check-out, poststudy, etc.
- To report the finding in written to the concerned person.
- To verify responses given with query generated.
- To provide SOP training to other staff as and when required.
- To check study related labels
- To maintain all QC reports in file and archive them.
- To request and maintain accountability of all study related documents.
- To check all study related documents for its legibility, accuracy and completeness.
- To solve QA/RA queries.
- To conduct study initiation meeting.
- To compile trial master file.
- Any other administrative or system related activities has assigned by the head-clinical or Designee.
- To help in report preparation
Education
MASTERS OF PHARMACY - Pharmaceutics
SIGMA INSTITUTE OF PHARMACY
Vadodara, India 04.2001 -
Bachelor of Pharmacy -
SIGMA INSTITUTE OF PHARMACY
Vadodara, India 04.2001 -
Skills
Regulatory guidelines expertise
Operational efficiency management
Performance evaluation
Operational efficiency enhancement
Guiding professional development
Proficient in MS Office
Quality control
Research Papers
Colon Targeted Moringa Gum Compression Coated Tablets of Capecitabin: A Factorial Approach
https://pharmacophorejournal.com/9edBABN
Optimization of floating bilayered tablets of Ketorolac Tromethamine: https://www.researchgate.net/publication/318655411_Optimization_of_floating_bilayered_tablets_of_Ketorolac_Tromethamine
Timeline
Team Lead - Clinical Reviewer
Gravita Oasis Review Solutions Private Limited
03.2022 - 06.2024
Research Associate (QC Auditor)
ACCUTEST RESEARCH LABORATORIES
10.2018 - 10.2020
MASTERS OF PHARMACY - Pharmaceutics
SIGMA INSTITUTE OF PHARMACY
04.2001 -
Bachelor of Pharmacy -
SIGMA INSTITUTE OF PHARMACY
04.2001 -