Vaishnavi Devang
Bangalore
Summary
I have completed my Master in Biotechnology from Bangalore University. I have a total 8/5 years of experience in clinical research domain with CRO and Pharma industry successfully managing deliverables within several phases of clinical trials across multiple therapeutic areas. Quick learner and with and willingness to serve the teams to perform the data management activities with quality.
Overview
10
10
years of professional experience
Work History
Associate Clinical Data Manager
Fortrea (Formerly Labcorp)
04.2023 - Current
- Combination of healthy and patient populations, multi-site, medium complexity in protocol design or client management requirements
- As a lead data reviewer and support to the lead Data Manager, perform all data operational tasks as appropriate to include, but not to be limited to data review and query management to ensure that quality standards (both internal and Sponsor) are achieved
- Work with the LDM to build study milestone timelines and demonstrate capability to read and follow study timelines for on-time deliverables
- Capable and knowledgeable on study design to make suggestions to study timelines when warranted
- Assist or lead the internal and external Data Management meetings
- Assist or lead to write, update/review and approve all required trial data management documentation
- Keeps LDM and internal operational team informed of pertinent project or sponsor related information (i.e., work scope changes, timeline impacts)
- Performs QC on all aspects of work performed in DM Operations to ensure that data quality and integrity is maintained
- Feedback constructively on relevant issues and initiate process review as appropriate
- Ensure all appropriate documentation and procedures are performed upon project completion for operations team
- Assist or lead the managing of the DM study team ensure client satisfaction is achieved through delivery of quality data
- Run metrics and KPIs as appropriate for the operations team to review for productivity, quality and on time delivery
- Support monthly budget reviews with units used by operations team for the month and internal initiatives for operations department
- Work with Line Manager on staff assignments and trainings for staff
- Post Data Management documentation and data management related administrative tasks as requested, including maintenance of eTMF as required
Associate Clinical Data Manager
Labcorp
02.2020 - 04.2023
- Combination of healthy and patient populations, multi-site, medium complexity in protocol design or client management requirement
- As a lead data reviewer and support to the lead Data Manager, perform all data operational tasks as appropriate to include, but not to be limited to data review and query management to ensure that quality standards (both internal and Sponsor) are achieved
- Work with the LDM to build study milestone timelines and demonstrate capability to read and follow study timelines for on-time deliverables
- Capable and knowledgeable on study design to make suggestions to study timelines when warranted
- Assist or lead the internal and external Data Management meetings
- Assist or lead to write, update/review and approve all required trial data management documentation
- Keeps LDM and internal operational team informed of pertinent project or sponsor related information (i.e., work scope changes, timeline impacts)
- Performs QC on all aspects of work performed in DM Operations to ensure that data quality and integrity is maintained
- Feedback constructively on relevant issues and initiate process review as appropriate
- Ensure all appropriate documentation and procedures are performed upon project completion for operations team
- Assist or lead the managing of the DM study team ensure client satisfaction is achieved through delivery of quality data
- Run metrics and KPIs as appropriate for the operations team to review for productivity, quality and on time delivery
- Support monthly budget reviews with units used by operations team for the month and internal initiatives for operations department
- Work with Line Manager on staff assignments and trainings for staff
- Post Data Management documentation and data management related administrative tasks as requested, including maintenance of eTMF as required
Sr. Clinical Data Specialist
Covance (Acquired by Labcorp)
02.2019 - 01.2020
- Perform aggregate review of clinical data by patient, site and / or project to identify data trends (patient safety, compliance, etc.) and / or data inconsistencies that require further investigation
- Generate, resolve, and track queries to address problematic data identified during data review activities
- Apply quality control procedures and checks to ensure data quality standards (client and Covance) are achieved
- Potentially serve as a reviewer of project documents such as protocols, CRFs (or eCRF Completion guidelines, Data Management Plans
- Perform Data review utilizing all applicable documents such as protocols, CRFs (or eCRFs and eDiary) etc
- Assist with the development of [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data
- Create and assist in the data review guidelines, make sure to be consistent with the clinical data model, and CRF/eCRF completion / monitoring conventions
- Assist in the development and testing of data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities
- May assist with the Lead Data Manager or Lead Data Reviewer to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team, as necessary
- Inform Lead Data Reviewer of overages in budgeted units and assist in Change Order Log process, if applicable
- Perform quality control on data management activities as appropriate to include, but not be limited to all study documentation, query generation and integration; to ensure that internal and client quality standards are achieved
- Support and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe
- Address client comments with the study team, as appropriate
- Mentor / Coach in training of project staff on project-specific, global, standardized data management processes
Clinical Data Analyst II
Chiltern (Acquired by Covance)
02.2018 - 04.2019
- Assist with review of clinical trial data in accordance with Data Management Plans and/or Data Review Guidelines and raise queries to resolve erroneous, missing data
- Demonstrates capability to read and follow study timelines for on-time deliverables and potential to assist with inputs on study design or capable to make suggestions to study
- Run and execute additional programs (special listings, reconciliation discrepancy listings, etc.) used to support the review of clinical trial data
- Generate, resolve, and track queries to address problematic data identified during aggregate data review activities
- Interacts with other project team members to support the set-up, maintenance, and closure of the Data Management aspects of the project and attend meetings as required
- Generate and QCs data listings for internal data review
- May assist or create dummy data to test edit checks and to test database screen design/functionality, SAS reports and data listing
- Demonstrates the ability to review Edit Check Specifications and Database specifications
- Post Data Management documentation and data management related administrative tasks as requested, including maintenance of eTMF as required
- Run study status reports in preparation for Sponsor meetings and to deliver on specific Sponsor request
- Supports the training of new staff on project specific Data Management processes
Associate Data Analyst
IQVIA
07.2015 - 01.2018
- Perform all data management tasks as appropriate to include, but not to be limited to data review and query management to ensure that quality standards (both internal and client) are achieved within stipulated timelines
- Assist with reviewing clinical trial data in accordance with Data Management Plans, Edit Check Specifications and/or Data Review Guidelines and raise queries to resolve erroneous, missing, incomplete data
- Run and execute additional programs, special listings, reconciliation discrepancy listings etc.) used to support the review of clinical trial data
- Posting of Data Management documentation and data management related administrative tasks as requested, including maintenance of eTMF as required
- Assist or create dummy data to test edit checks and to test database screen design/ functionality, SAS reports and data listing
- Interact with other project team members to support the set-up, maintenance, and closure of the Data Management aspects of the project and attend meetings as required
- Assist or create dummy data to test edit checks and to test database screen design/ functionality, SAS reports and data listing
Education
Master of Science - Biotechnology
Jnana Bharati Campus
Bengaluru, India06-2010
Skills
- Electronic data capture
- Data cleaning
- Clinical data management
- Data reporting
- Data validation techniques
- Database design
- Effective communication
- Training and mentoring
- Active listening
- Adaptability
- Analytical thinking
- User acceptance testing
- Test script writing
- Discrepancy management
Accomplishments
- Collaborated with team of 8 in the development of assigned projects.
- Achieved awards by completing tasks with accuracy and efficiency.
- Supervised team of 10 staff members in Testings for many projects.
Interiors, painting and travelling
I am little Obsessed with staying organized and making everyone`s life easier. It brings such a genuine joy to my heart to take the burden off my loved ones` shoulders, and I always do anything I can do to enhance that. Work is no different. There aren`t many things that can grow a company the way that trust and dependability can, and I pride myself so dedicated to both.
Traveling ia like fun way to explore new places, try new foods, and meet new people. It helps me to develop new skills and become more open-minded.
Painting is something I always love to do when sometime I go low or when I am too happy. It refills me with joy and completeness.
Languages
English
Advanced (C1)
Hindi
Advanced (C1)
Malayalam
Elementary (A2)
Telugu
Advanced (C1)
Tamil
Advanced (C1)
Timeline
Associate Clinical Data Manager
Fortrea (Formerly Labcorp)
04.2023 - Current
Associate Clinical Data Manager
Labcorp
02.2020 - 04.2023
Sr. Clinical Data Specialist
Covance (Acquired by Labcorp)
02.2019 - 01.2020
Clinical Data Analyst II
Chiltern (Acquired by Covance)
02.2018 - 04.2019
Associate Data Analyst
IQVIA
07.2015 - 01.2018
Master of Science - Biotechnology
Jnana Bharati Campus
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