Jyothi Shetty
Moodbidri
Summary
Dynamic clinical professional with extensive experience at IQVIA, excelling in critical clinical data management and risk monitoring. Proven ability to enhance team collaboration and drive trend analysis, leading to improved study outcomes. Adaptable and results-oriented, I thrive in fast-paced environments, ensuring compliance and quality in clinical trials
Overview
23
23
years of professional experience
Work History
Centralized Monitor
IQVIA
Bangalore
12.2024 - Current
- Manage assigned studies with minimal supervision.
- Establish and maintain effective project/ site communications.
- Participate in (study) team meetings and implement action items.
- Act as point of contact for assigned deliverables for specific customers or projects.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
- Manage the operational insight of the assigned project(s) and complete the study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and agree on action plan, review, triage, and action clinical study alerts, monitor clinical operation plan (COP) compliance etc.
- With guidance, provide Inputs to clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections.
- Perform Management of triggers and preparation of i-site reports for respective sites and countries for assigned studies.
- Perform Subject Level Data Review that requires further investigation with the clinical site to determine overall accuracy (inclusion & exclusion criteria. Review any other information as necessary to determine overall readiness of the patient information for next level review.
- Conduct periodic review of site level KRIs and historic site performance.
Medical Data Reviewer
IQVIA
Bangalore
12.2015 - 12.2024
- Served as a Subject Level Data reviewer (SLDR) in centralized monitoring studies (risk- based monitoring execution model) and identify any medical discrepancies in patient reported data by performing Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy in centralized monitoring studies.
- Review all inclusion and exclusion criteria to ensure each patient meets minimum level of acceptance into the clinical trial.
- Review investigation product dosing records to determine adherence to protocol and identify possible inaccurate / missed dosages.
- Review all reported Adverse Events (AEs), Concomitant Medication and medical history information to ensure all supporting information is expected and/or implausible data is verified and adherence to protocol expectations and its impact on other patient reported/observed information (e.g. Laboratory results, AEs, etc.) as per the protocol, DMP (Data Management Plan).
- Ensure end-of-treatment (EOT) and end-of-study (EOS) information is correctly documented to determine primary reason for the patient ending treatment or ending participation in the clinical trial.
- Review all laboratory results to ensure completeness of information and adherence to protocol schedule of events and determine if reported laboratory values represent a potential safety condition not reported in the AE information for the patient.
- Accessing Medical/clinical data by navigating through electronic health records (EHR/EMR) and other medical databases, entered specific data into congruent electronic data systems per specified disease, SOP's and project requirements.
- Ability to understand the diagnostic, pathology and radiology reports, inclusion, exclusion criteria, adverse events, hospitalization data, medications details and categorized the data accordingly.
- Serving as back up POC (Point of contact) for multiple studies.
- Mentoring and training MDR's on study documents and process.
- Act as SME to train and guide new MDR in onboarding and professional development. Generating study metrics.
- Generating and sharing study reports like query detail reports, DMP edit check report with team.
- Involved in allocating and distributing work to team on daily basis.
- Keeping track of study timelines and quality for individual MDR involved in study.
- Working as quality reviewer for multiple studies at portfolio level.
- Reviewing clinical trial data to identify medical and operational trends presenting the final analysis to the clinical study team (clinical scientist).
- Ensure all the study timelines meeting as per Sponsor SLA.
- Query management and query escalation to clients using Spotfire, Medidata Rave and communication log.
- Involved in analytics of the queries for identifying the trends. Reviewing data and identifying errors/inconsistencies.
- Hands on experience on eTMF (Veeva Vault) documents.
Quality Executive
A.J. Hospital and Research Centre
Mangalore
12.2012 - 11.2014
- Overseeing the quality aspect of clinical departments.
- Preparing reports pertaining to the standard set for Hospital Quality Control. Conducting the internal audit of clinical departments based on various quality indicators and submitting the report in the quality assurance meeting.
- Assisting the Quality Officer in the completion of documents. Planning of continuous improvement in the existing quality standards.
- Coordinating in training programs relevant to Quality assurance department staff.
- Collecting all the quality indicators from various departments and submitting and presenting the consolidated report in the quality assurance meeting.
Duty Medical Officer
Alva's Ayurveda Medical College Hospital
Moodabidri
03.2009 - 11.2011
- Attending patients in OPD and IPD.
- Assisted senior physicians and surgeons during assessments, examinations and surgical interventions.
- Directed and coordinated patient care activities of nursing and support staff. Completed patient referrals to other medical specialists.
- Trained and supervised medical students and residents engaged in special activities and procedures.
- Assisted with day-to-day operations.
Duty Medical Officer
Lourd's Hospital
Karkala
12.2005 - 09.2006
- Attending patients in OPD and IPD.
- Assisted senior physicians and surgeons during assessments, examinations, and surgical interventions.
- Directed and coordinated patient care activities of nursing and support staff. Completed patient referrals to other medical specialists.
- Trained and supervised medical students and residents engaged in special activities and procedures.
- Assisted with day-to-day operations.
Duty Doctor
MMDRC Hospital
Kanhangad
02.2003 - 01.2005
- Conducting normal deliveries independently, Assisting Cesarean sections and other Gynec Surgeries.
- Attending patients in OPD and IPD.
- Assisted senior physicians and surgeons during assessments, examinations and surgical interventions.
- Directed and coordinated patient care activities of nursing and support staff. Completed patient referrals to other medical specialists.
- Trained and supervised medical students and residents engaged in special activities and procedures.
- Assisted with day-to-day operations.
Education
MHA - Hospital administration
ALVA'S College of Hospital Management
Moodabidri06.2012
BAMS - Ayurveda Medicine & Surgery
ALVA'S Ayurveda Medical College
Moodabidri04.2002
Skills
- Critical clinical data management
- Risk monitoring
- Trend analysis
- Team collaboration
- Adaptability
Academic Chronicle
- MHA (Masters in Hospital administration), ALVA'S College of Hospital Management, 06/01/12
- BAMS (Bachelor of Ayurveda Medicine & Surgery), ALVA'S Ayurveda Medical College, 04/01/02
System Experience
- CDMS Platform: RAVE Visualization Tools: Spotfire Visualization and Data Management Tool.
- Veeva Vault
- Working proficiency in SharePoint, Windows based applications such as MS Office, Excel, Excel Tools, MS Word, Power point etc.
Career Synapsis
- A Medical graduate with total experience of 17+ years in various sectors like, Clinical research, Medical Insurance, Hospital administration. I am inclined to work in Pharma companies, CRO, and Biotechnology organizations.
- At present working as centralized monitor in IQVIA Bangalore in Risk based monitoring trials/ Centralized clinical trial module.
- Having total 10+ years of work experience in handling various phases of clinical trials with different therapeutic areas such as Neuroscience, cardiovascular, oncology and Nephrology.
Timeline
Centralized Monitor
IQVIA
12.2024 - Current
Medical Data Reviewer
IQVIA
12.2015 - 12.2024
Quality Executive
A.J. Hospital and Research Centre
12.2012 - 11.2014
Duty Medical Officer
Alva's Ayurveda Medical College Hospital
03.2009 - 11.2011
Duty Medical Officer
Lourd's Hospital
12.2005 - 09.2006
Duty Doctor
MMDRC Hospital
02.2003 - 01.2005
MHA - Hospital administration
ALVA'S College of Hospital Management
BAMS - Ayurveda Medicine & Surgery
ALVA'S Ayurveda Medical College