Shivani Trivedi
Bangalore
Summary
Highly skilled Clinical Data Specialist with substantial experience in maintaining and auditing patient clinical data. Strong background in compliance with regulatory standards, managing databases, and ensuring accuracy of medical records. Recognized for innovative problem-solving skills and improving data management procedures to enhance efficiency. Proven ability to build strong relationships with multidisciplinary teams to ensure quality of data collection and reporting.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Clinical Data Specialist (Data Operations Co-ordinator)
IQVIA Asia Pacific
Bengaluru
05.2022 - Current
- Managed global data for multiple clinical trials across diverse therapeutic domains ensuring precision using RAVE Classic and iMedidata RAVE.
- Contributed to projects involving various areas including inflammation, Hematology and Oncology, Early Oncology Portfolio, and ISD.
- Ensured quality of services by overseeing external vendors in clinical trial operations.
- Assisted in the design, development, and implementation of database systems for tracking clinical research studies.
- Provided technical support to end users on clinical database applications.
- Provided guidance and mentorship to junior team members.
- Participated in user acceptance testing for new versions of clinical trial software applications.
- Updated project documentation including study protocols, monitoring plans.
- Coordinated with internal stakeholders during audits conducted by sponsors or regulatory agencies.
- Conducted quality control checks on databases prior to submission of regulatory filings.
- Analyzed complex datasets to identify trends or patterns in the data.
- Performed data validation tasks to ensure accuracy and completeness of clinical trial data.
- Successfully prioritized and completed more than 9 studies within agreed timelines, with expertise in managing discrepancies, conducting IPD/ Vendor data reconciliation and overseeing activities like Missing Labs, Manual Listing review, SAS Programming, DRT and Non-conformant data exposure.
Associate Clinical Data Co-Ordinator
IQVIA Asia Pacific
Bengaluru
11.2020 - 05.2022
- Ensured compliance with applicable regulatory standards including GCP and ICH guidelines.
- Provided technical support to clinical staff during trials as needed.
- Identified potential issues related to data accuracy and integrity.
- Performed quality control checks to verify accuracy of entered information.
- Developed training materials for new employees related to clinical data management practices.
- Assisted with the preparation of statistical analysis plans.
- Participated in meetings with stakeholders to discuss project timelines and deliverables.
- Documented any changes made to the database structure or content.
- Prepared presentations outlining key findings from completed studies.
- Worked closely with statisticians, clinicians, and other team members to ensure proper handling of confidential patient data.
- Tailored data management plans to specific projects to effectively reach deadlines.
- Increased productivity and efficiency by regularly reevaluating processes and technologies.
Trainee Clinical Data Co-Ordinator
IQVIA Asia Pacific
Bengaluru
11.2019 - 11.2020
- Started my professional career at IQVIA as a fresh graduate.
- Enhanced understanding of Clinical Data Management by working alongside seasoned industry professionals on a successful cardiovascular trial.
- Contributed to the completion of various assignments and duties by providing support to team members.
- Participated in brainstorming sessions to generate ideas for marketing campaigns.
- Assisted senior team members in acquiring job tasks and roles.
- Facilitated group discussions among participants during trainings.
- Resolved any issues that arose during the course of a training session.
- Identified needs of customers promptly and efficiently.
- Maintained positive working relationship with fellow staff and management.
- Implemented strategies to take advantage of new opportunities.
Project Fellow
Biotech Consortium India Limited (BCIL)
Noida
09.2018 - 06.2019
- Contributed to projects as a Trainee / Fellow conducting research at Codon Biotech Pvt Ltd, Noida.
- This program was approved and certified by BCIL, Govt. of India.
- Conducted research, prepared reports and presentations on project activities.
Education
CRO Training, Clinical Research, Pharmacovigilance, Clinical Data Management -
AM Services Clinical Research Training Academy
R.R. Nagar, Bangalore12.2019
Master of Science - MS, Biotechnology - Biotechnology
Jaipur National University
Jaipur, Rajasthan12.2018
Bachelor of Science - B.Sc., Biology, General - Biology
Chatrapati Sahuji Maharaj Kanpur University
Kanpur, Uttarpradesh12.2016
Skills
- Clinical Data Management
- CDM processes
- Clinical Research
- Reconciliation process
- Project management
- Clinical Trial Management
- Clinical trial Monitoring
- ICH-GCP
- Informed consent Process
- Reporting (AE, SAE)
- Case Report form
- CRF Designing
- Essential Documents
- Trial Master File
- Good clinical practice (GCP)
- Data Validation
- IPD, Vendor and SAE Reconciliation
- Data discrepancy or Query management
- Informed Consent Form Process
- Patient Recruitment
- Dataset Review and Issue Identification
- Document review through eTMF
- Tools proposed by the sponsor
- Windows Office, word, excel, PowerPoint
- Project management abilities
- Decision-making capabilities
- Regulatory compliance understanding
- Audit management
- Time management abilities
- Effective Communication
- Analytical Skills
- Problem-Solving
- Team building
- Team Collaboration
- Time Management
Certification
- Certificate course in office automation and internet, Rajeev Gandhi Computer Saksharta Mission - India, 12/01/15, Present
- Tips for Working Remotely, LinkedIn, 03/01/21, Present
- The Data Science of Healthcare, Medicine, and Public Health, with Barton Poulson, LinkedIn, 04/01/21, Present
- Effective Listening, LinkedIn, 04/01/21, Present
- SAS 9.4 Cert Prep: Part 01 SAS Programming Essentials, LinkedIn, 04/01/21, Present
- Artificial Intelligence Foundations: Machine Learning, LinkedIn, 04/01/21, Present
- Project Management Foundations, LinkedIn, 04/01/21, Present
- SQL for Non-Programmers, LinkedIn, 04/01/21, Present
Languages
Hindi
First Language
English
Proficient (C2)
C2
Timeline
Clinical Data Specialist (Data Operations Co-ordinator)
IQVIA Asia Pacific
05.2022 - Current
Associate Clinical Data Co-Ordinator
IQVIA Asia Pacific
11.2020 - 05.2022
Trainee Clinical Data Co-Ordinator
IQVIA Asia Pacific
11.2019 - 11.2020
Project Fellow
Biotech Consortium India Limited (BCIL)
09.2018 - 06.2019
CRO Training, Clinical Research, Pharmacovigilance, Clinical Data Management -
AM Services Clinical Research Training Academy
Master of Science - MS, Biotechnology - Biotechnology
Jaipur National University
Bachelor of Science - B.Sc., Biology, General - Biology
Chatrapati Sahuji Maharaj Kanpur University
- Certificate course in office automation and internet, Rajeev Gandhi Computer Saksharta Mission - India, 12/01/15, Present
- Tips for Working Remotely, LinkedIn, 03/01/21, Present
- The Data Science of Healthcare, Medicine, and Public Health, with Barton Poulson, LinkedIn, 04/01/21, Present
- Effective Listening, LinkedIn, 04/01/21, Present
- SAS 9.4 Cert Prep: Part 01 SAS Programming Essentials, LinkedIn, 04/01/21, Present
- Artificial Intelligence Foundations: Machine Learning, LinkedIn, 04/01/21, Present
- Project Management Foundations, LinkedIn, 04/01/21, Present
- SQL for Non-Programmers, LinkedIn, 04/01/21, Present
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