Dr. Ramanpreet Kaur, BDS
Bangalore
Summary
Established clinical research professional with 6 years of experience in onsite and centralized monitoring as Clinical Data Manager, Clinical Research Associate & Medical Data Reviewer. Additionally, brings 8 years of prior experience as a dental practitioner. Proficient in site management and monitoring, ICH-GCP, RAVE (EDC), VCV, eTMF and mentoring & training with strong verbal, written, and interpersonal communication skills.
Overview
14
14
years of professional experience
Work History
Clinical Data Manager
Johnson and Johnson
Bangalore
07.2023 - Current
- Working alongside Study Responsible Physician and Scientist to establish, align, and confirm complex scientific clinical data review expectations for assigned trials.
- Involved in study-related activities from the protocol design stage onwards, providing input into the study-specific and/or indication-specific data collection .
- Developing comprehensive ‘Integrated Review Plan’ at trial and disease area levels, with inputs from the medical leaders ensuring rigorous data review.
- Leading or participating, depending on the complexity of the project, in implementing process, system, and tool improvement initiatives within CDM scope.
- Reviewing clinical study data in the eCRFs.
Clinical Research Associate
Astrazeneca
Bangalore
07.2021 - 01.2023
- Successfully managed and monitored nine onsite teams working in three different oncology studies, resulting in meeting all milestones on time and achieved 100% compliance with the protocol requirements.
- Onboarded multiple sites and investigators, and performed site feasibility, site qualification, site initiation and interim monitoring visits.
- Trained and supervised investigators and clinical research staff to ensure regulatory requirements were met and quality and integrity of clinical study data were maintained.
- Created Quality Issues (QI's) in VCV, performed Root Cause Analysis (RCA) and Corrective and Preventive Actions (CAPA).
- Performed eTMF QC to ensure studies were Inspection ready at all times.
- Worked on clinical study agreements and budget negotiations with the sites.
- Worked closely with the global study team (GST) to maintain optimum levels of communication, with 100% satisfaction among stakeholders and vertical members.
Medical Data Reviewer
IQVIA
Bangalore
07.2018 - 07.2021
- STUDY START UP : Managed clinical data for multiple studies including a high-volume phase 3 study of approx. 1600 patients. Created data management plan (DMP) and Spotfire Requirements Document (SRD) and collaborated in design of the visualizations per study requirements. Performed UAT for Spotfire before release into production. Reviewed protocol at its drafting stage and ensured medical monitoring plan is in accordance with the study requirements. Experience in RAVE & VCV.
- STUDY CONDUCT : Conducted Subject Level Data Review (Subject's eligibility, protocol compliance and targeted review of patient data), Study level data review and aggregated data review along with adjudication of protocol deviations. Ensured patient safety by reviewing reported Adverse Events(AEs) and Serious Adverse Events(SAEs), concomitant medications and medical history information. Performed data analysis by reviewing visualizations using SPOTFIRE and identified potential issues of concern, resulting in their timely identification & resolution and 100% quality for the allocated work.
- STUDY CLOSE-OUT : Collaborated with study team/stakeholders, performed query management and holistic review of medical data before final database lock & achieved 100% compliance with study timelines.
- TEAM MANAGEMENT : Managed and mentored team members by allocating work, generating study reports, and conducting quality control of studies helping team members work efficiently and productively.
Resident Dentist, Head of the Clinic
Clove Dental
Bangalore
09.2016 - 05.2018
- Performed comprehensive dental examination, diagnosis, planning and treatment of dental conditions.
- Managed clinical and administrative staff and implemented policies and directives.
- Trained new staff on dental procedures and patient management.
Associate Dental Surgeon
Chisel Dental Clinic
Bangalore
04.2014 - 03.2016
Associate Dental Surgeon
Yadav Dental Clinic
Jalandhar
02.2011 - 02.2014
Education
Course - Implantology
Osstem, Professional Training Course
BangaloreBachelors - Dental Surgery
Sri Guru Ram Das Institute of Dental Science
Amritsar, PunjabSkills
- Medical data review (ONCOLOGY & CARDIOVASCULAR TA)
- Centralized monitoring
- Onsite monitoring (Trial Oversight)
- ICH-GCP
- RAVE (EDC)
- VCV, eTMF
- MS Office
Languages
- English
- Hindi
- Punjabi
Additional Information
- Licensed Dental Practitioner under Punjab Dental Council (2011)
- Certificate of Excellence in Leadership as Clinical Head, Clove Dental - Koramangala, Bangalore INDIA(2017)
References
- Ranjeetha Noorithaya (Associate Director Data Management Leader, Johnson & Johnson)
Contact No. 9986047790
- Sandeep A.V (Country Head, Site Management & Monitoring, Astrazeneca)
Contact No. 9845079472
- Manivamsi Sunkula (Senior Manager, Labcorp, Ex-IQVIA)
Contact No. 9731714083
- Dr. Sankaranarayanan Subramanian (Chennai City Head, Clove dental)
Contact No. 9087499888
Timeline
Clinical Data Manager
Johnson and Johnson
07.2023 - Current
Clinical Research Associate
Astrazeneca
07.2021 - 01.2023
Medical Data Reviewer
IQVIA
07.2018 - 07.2021
Resident Dentist, Head of the Clinic
Clove Dental
09.2016 - 05.2018
Associate Dental Surgeon
Chisel Dental Clinic
04.2014 - 03.2016
Associate Dental Surgeon
Yadav Dental Clinic
02.2011 - 02.2014
Course - Implantology
Osstem, Professional Training Course
Bachelors - Dental Surgery
Sri Guru Ram Das Institute of Dental Science
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