Dr. Priya Gamre
Manager, Medical Data Review-Centralized Monitoring/Risk Based Monitoring, Clinical Operations
Bengaluru,KA
Summary
Dr. Priya S. Gamre
Manager, Medical Data Review, Clinical Operations, Centralized Monitoring/Risk Based Monitoring/Data Management/ Remote Monitoring
Senior professional with total 15+ years of work experience; 10 years in Clinical Research and 5 years in Clinical domain. Clinical Research experience of working at site, Ethics Committee and CRO in leading and managing various Clinical Trial Projects.
Substantial Line Management and Project Management experience across various Therapeutic Areas for 5 years with demonstrated team leadership involving team management, mentoring, coaching, delivering trainings to project staff.
Responsible for client co-ordination and service delivery as Therapeutic Manager/Line Manager/SME in the field of Risk based monitoring/centralized monitoring. Leading Portfolio Productivity metrics, Quality, Project Deliverables, Clinical Operations, Talent Development programs, Team Engagement activities. Acting as Point of Contact for Training.
Overview
6
6
years of post-secondary education
19
19
years of professional experience
Work History
Manager, Medical Data Review
IQVIA
Bangalore, Karnataka
10.2012 - Current
- People Management of 20-22 members who are from various backgrounds.
- Manage staff in accordance with organization’s policies.
- Appraising performance and guiding professional development; engaging, motivating and rewarding employees; addressing employee issues and resolving problems.
- Approve actions on human resources matters.
- Contribute to the development of direct reports through administrative direction, coaching, mentoring, and timely feedback.
- Part of recruiting team as an interview panel and support in building retention strategies.
- Initiated and lead Onboarding process for new hires ensuring effective learning of processes within stipulated time.
- Leading various key operational initiatives and business level metrics and continuously look for innovative ways to improve efficiency.
- Goal setting for a team in alignment with Organization policy.
- Tracking of Productivity Metrics at portfolio level and implementation of various majors to increase efficiency.
- Training Point of Contact.
- Initiated and led various teams/processes as a part of quality, knowledge build and team engagement e.g.
- Skill Gap Analysis, Capability build, Science Committee, Newsletter, monthly Townhall, Team Engagement Activities, Workshops, etc.
- Part of customer-oriented meetings representing team performance at business level and multiple studies across different therapeutic areas.
- TA Manager for Haem-Oncology and Nephrology TA and providing oversight to 10-15 projects for seamless deliverables.
- Served as Subject Matter Expert and Quality Lead for one of the key customer process.
- Ensure data quality focus to audit readiness.
- Continuously look for opportunities to improve efficiency of tasks and quality of deliverables.
- Maintain strong internal and external customer relationships.
Associate Medical Data Review Manager
10.2013 - 12.2015
- Team Lead Role:.
- Responsible for project delivery of clinical development phase EDC studies.
- Review and approval of study documents during Study Start Up phase.
- Creating required Data Elements and Edit Checks.
- Providing requirement to programmers to create visualizations as per study requirement and then performing User Acceptance Testing for Spotfire and validate the edit checks for the study,.
- Inputs for amending the eCRF completion guidelines; ensuring appropriate data capture by sites.
- Performing medical/holistic review as per study design providing the client with the monthly metrics update,.
- Conduct basic quality control procedures,.
- Ensuring Critical Milestones for the study are achieved within stipulated timelines.
- Training the resources for medical data review using RAVE platform and using Spotfire Tool.
- Doing thorough quality check to ensure data review activities in alignment with study documents, set processes and in accordance with ICH-GCP guidelines.
- Received Client appreciations for study deliverables.
- Represent project at multi-disciplinary team meetings and external meetings.
- Conduct in-stream data trend analysis in support of data quality and integrity (includes protocol compliance and medical review of subject data).
- Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
Sr. Clinical Data Coordinator/Sr. Medical Data Reviewer
10.2012 - 10.2013
- Subject Level Data Review activities for studies across multiple Therapeutic Areas.
- Worked on EDC studies using Medidata RAVE platform.
- Efficient review using visualizations and graphical representation in Spotfire Tool.
- Effective Query Management Process Triesta Sciences, HCG, Bangalore 2 Years.
Clinical Data Coordinator
01.2008 - 01.2010
- Co-ordinator for Ethics Committee:.
- Conducted ICH-GCP, SOP and OHRP training of all Ethics Committee members.
- Registration of Ethics Committee to OHRP.
- Receiving, handling and compiling of documents submitted to Ethics Committee.
- Organizing Ethics Committee meetings on regular basis and within the time frame.
- Preparation of Agenda and Minutes of Meetings.
- Presentation of study documents during the meetings.
- Coordinating with site during Serious Adverse Events.
- Coordinating with Investigators, study coordinators and CRAs.
- Tracking of all documents submitted to Ethics Committee.
- Archiving of study documents.
- Assisting in internal audits.
- Study Co-ordinator:.
- Study coordinator for two oncology protocols including Phase III study.
- Actively involved in pre-screening activity.
- Patient recruitment and retention of patients.
- Process of administering the informed consent to potential patients and discussing in detail the patient information sheet.
- Complete the Case Record Forms within the timelines and with minimal errors.
- Schedule subject visits as per the protocol to ensure maximal subject compliance retention.
- Coordinate all lab related activities – shipment of samples through the designated courier and ensure timely receipt of the lab reports.
- Compile and update the Trial Master File.
- Maintain the study related logs – screening, enrolment, drug administration, temperature and other communication logs.
- Manage the accountability of the Clinical Trial Material.
- Coordinating Ethics Committee Submission & Approval.
- Coordinate for any query from the Ethics Committee.
- Assist in writing protocol for Investigator initiated trial.
- Translation of documents in relevant languages.
- Organizing Project Meetings.
- Prescreening activity for all protocols and maintaining the logs.
- Involved in Study start up activity.
Medical Office/Duty Doctor/Family Physician
MULTIPLE HOSPITALS
01.2001 - 01.2006
- Worked in ICU, Paediatric Hospital, OPD, Oncology Department, etc.
Education
PG Diploma - undefined
Advanced Diploma - Clinical Trials Management and Regulatory Affairs
Vaatsalya Academy of Clinical Research
01.2007 - 01.2008
Bachelor of Homeopathic Medicine and Surgery (BHMS) - undefined
Bharti Vidyapeeth Medical Collage
01.1996 - 01.2001
Certification in Acupuncture, Pune - undefined
: HSC from Pune University PCB: 87 - undefined
: SSC from Pune University 84%. - undefined
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Additional Information
- PERSONAL PROFILE- , D.O.B : 22-04-1977
Quote
The way to get started is to quit talking and begin doing.
Walt Disney
Skills
Business planning
undefinedTimeline
Associate Medical Data Review Manager
10.2013 - 12.2015
Manager, Medical Data Review
IQVIA
10.2012 - Current
Sr. Clinical Data Coordinator/Sr. Medical Data Reviewer
10.2012 - 10.2013
Clinical Data Coordinator
01.2008 - 01.2010
Advanced Diploma - Clinical Trials Management and Regulatory Affairs
Vaatsalya Academy of Clinical Research
01.2007 - 01.2008
Medical Office/Duty Doctor/Family Physician
MULTIPLE HOSPITALS
01.2001 - 01.2006
Bachelor of Homeopathic Medicine and Surgery (BHMS) - undefined
Bharti Vidyapeeth Medical Collage
01.1996 - 01.2001
: SSC from Pune University 84%. - undefined
: HSC from Pune University PCB: 87 - undefined
Certification in Acupuncture, Pune - undefined
PG Diploma - undefined
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