Pooja Bansal
Senior Clinical Data Specialist
Bangalore
Summary
Clinical Data Personnel with 6+ years of experience ensuring that data for clinical trials is properly collected and validated. Excellence track record when it comes to consistent quality and reliability in carrying out research duties according to regulatory guidelines. Now looking forward to joining a highly reputed and professional clinical research work environment and apply my best data management practices and experiences to gain excellent advancement in my career.
Overview
6
6
years of professional experience
5
5
years of post-secondary education
2
2
Languages
Work History
Senior Clinical Data Specialist
LABCORP
Bangalore
09.2021 - Current
- As a Lead Data Reviewer (LDR) at LabCorp, I independently perform all clinical data management activities on assigned projects, commensurate with experience and/or project role
- Further responsibilities include support on data processing activities and study level documents and takes lead of all the project related activities and help the other peer members
- Experience of working on EDC systems – Rave X, and IBM Clinical EDC systems
- Expertise in working with vendor management, team management, client interaction and communicating with various other departments within the Clinical Research Domain
- Strong and comprehensive CDM skills in different phases of the clinical data management including study start up, study conduct and study lock
- Developed and maintained Data Management Plans (DMP), CRF Completion Guidelines (CCGs), Data Review Plan (DRP)/Data Review Guidelines (DRG) and made sure they are followed throughout the project life cycle
- Completion, understanding, and documentation of required Company and Sponsor project and non−project training within the required timeframe
- Experienced in Database Development in creating Edit Checks, Query Logics and User Acceptance Testing (UAT)
- Worked extensively during study conduct on validating the data, cleaning the data, Discrepancy management, SAE reconciliation and Lab reconciliation
- Coordinated with the Manager-Data Management to track, report status and progress of data management for assigned trials
- Responsible for Database Lock of two Phase-II studies as an additional LDR
- Used critical thinking to break down problems, evaluate solutions and make decisions.
CLINICAL DATA REVIEWER
GSK
Bangalore
04.2020 - 08.2021
- Experience of working on EDC systems – Inform and Veeva EDC
- Experience of working on Phase I, Phase II and Phase III Vaccine studies
- Experience of working on Veeva TMF
- Performed tasks in compliance with Standard Operating Procedures (SOPs)/Work Instructions (WIs), regulatory directives, and study specific plans and guidelines
- Data Sharing Process : Extensively worked on Data sharing process (Sharing eCRF and non- eCRF data/listings with the investigators) of 3 studies by closely collaborating with the programmers to resolve issues
- Closely collaborating with SDM on updating the IDRP, CRF Completion Guidelines and Non-medical cleaning guidelines
- Data and query review : This includes SAS listing review, Vendor Reconciliation and Discrepancy management
- SME for Newcomers Forum– Recognized as an SME for Data review team
- Responsible for closing any gaps and issues, providing trainings on Veeva EDC and Query Studio in Inform to peer team members
- Risk Management – Risk champion from my team who was accountable for Risk analysis in CDM team with thorough understanding of Management tasks with ability to critically evaluate the information in relation to other key project documents and processes
- To support the business in applying risk management processes and techniques with the aim of increasing awareness, ownership and management of risks leading to improved business performance.
CLINICAL DATA SPECIALIST
IQVIA
Bangalore
04.2018 - 03.2020
- Data and Query Review - Issue queries and review query responses with the highest level of quality based upon the Data Review Plan, Aggregate Checks (DM listings), Reconciliation (Lab, SAE, ECG, etc.), and limited other assistance for review from others (Biostatistical, Medical review, Client, etc.)
- Experience in EDC system : Rave, Inform and Express 5.3 and 5.4 versions
- Update DM study documentation – Data Management Plan (along with supporting DM documents), CRF Completion guidelines, Data Entry guidelines, Edit specifications, Reconciliation guidelines, and/or Report specifications
- Point of communication between Lead and internal team while working on multiple studies
- Communication and Reporting - Provide feedback to improve the data management system or reports or Provide feedback to the Lead DM and Programmers to improve the deliverable
- Proactive risk identification w.r.t timelines, quality and especially, leave plans to how it impacts project deliverables – Being proactive in providing timeline details to the team and leave plans to the lead
- Flag any risk or support required to Operations manager
- Performed Role of Validation Coordinator (SPOC) – Taking accountability to manage delivery of Project forms and responsible for providing Study access to the new team member, mentoring, and guiding them in signing off all the relevant documents
- Discussion of roadblocks for getting processes done in a timely manner and Produce Study Metric reports to internal/external project team
- Provide the DM lead or PM with status updates on tasks that are assigned
- Participate in preparing risk analysis and lead the team with action items
- Lead Role- Serve as Lead DM or Back-up DM lead
- Produce and Review Metric reports for internal/external project team like Query reports, Form status reports etc
- Review Project budgets and staffing projections for data management activities
- Provide the DM lead or PM with status updates on tasks that are assigned
- Assist with the on-the-job training of DM staff for the study and ensuring that quality, timeline, and productivity requirements are met
- Involved in understanding scope of work, budget, and scope assumptions for projects
- Unit Testing - Updating Study design export document for any Impact assessments in BioClinica Express study
- Providing all supporting documentation needed for post-productional changes, performing Unit testing of all required changes, and providing timely updates and feedback to the client.
CLINICAL DATA REVIEWER
BIOCLINICA INC
Mysore
06.2016 - 04.2018
- Query Management - Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database
- Perform manual checks as specified in guidelines and protocol, issue manual queries and track, review and close all query responses (Query management) till data base lock
- Conduct Data review- Listings Review
- Write and resolve data clarifications
- Develop and test databases and edit specifications
- External Vendor Reconciliation (LAB, PK, ECG, CGI/Biomarkers, SAE) - Perform reconciliation of central laboratory and/or third-party vendor data
- Experience in EDC system, Express 5.3 and 5.4 versions
- Project communication among study team members during different stages of study related to deliverable of each activity as per projected timeline
- To assist with the training of less experienced Clinical Data management team member in data management activities
- Perform other project activities as required to ensure that study timelines are met by maintaining productivity and quality matrices and trackers
- Contribution in process improvement with a focus on streamlining our process to add value in our business and to meet the client expectations
- Handling multiple studies at same time and managing study timelines and deliverables
- Providing reports and status updates to clinical data manager
- Generating metrics and reports for current state of study
- Timely delivery of quality data in a time bound manner.
Education
Bachelor of Science - Biotechnology
Panjab University
Chandigarh 05.2010 - 04.2013
Master of Science - Bioinformatics
Panjab University
Chandigarh 05.2013 - 05.2015
Diploma - Clinical Research and Data Management
Clini India
Bangalore 04.2016 - 06.2016
Skills
Experience with clinical data management systems, proficiency in - Express 53 and 54, Medidata Rave, Inform, Veeva, IBM Clinical development
Timeline
Senior Clinical Data Specialist
LABCORP
09.2021 - Current
CLINICAL DATA REVIEWER
GSK
04.2020 - 08.2021
CLINICAL DATA SPECIALIST
IQVIA
04.2018 - 03.2020
CLINICAL DATA REVIEWER
BIOCLINICA INC
06.2016 - 04.2018
Diploma - Clinical Research and Data Management
Clini India
04.2016 - 06.2016
Master of Science - Bioinformatics
Panjab University
05.2013 - 05.2015
Bachelor of Science - Biotechnology
Panjab University
05.2010 - 04.2013
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