Chetana J Kunte
Bangalore
Summary
Clinical data management professional having over 8.7 years of experience in handling Rave and Inform studies; seeking assignment in the CRO Industry.
Overview
13
13
years of professional experience
Work History
Data Manager II
Accenture Services Pvt Ltd
08.2022 - Current
- Review and reconciliation activities using clinical database and also using the Third-party vendor data
- Performed advanced aspects of the data cleaning process, with a high degree of accuracy and in accordance with GCPs and SOPs/WPDs
- Key responsibilities were to perform initial review of data discrepancies and database updates, freezing, locking, UAT, data listing reviews, LNR entry, preparation of memo to sites, reconciliation of Serious Adverse Events, PK recon and third party vendor data
- Worked as a back-up for metrics preparation, importing and exporting data for studies
- Work experience in RAVE Database for Oncology studies
- Conduct data review
- Write and resolve data clarifications
- Develop and test databases
- Attend study team meetings as necessary to discuss study progress and risks if any and highlight the issues related to Vendor recon during these calls to fix issues as and when found
- Follow-up with the external vendor for timely transfers of the external vendor data
- Re-issue and close out (as required) coding queries and follow up on Field Monitor queries during study close out and emergency situations
- Perform reconciliation of the clinical and safety databases, reconciliation of central laboratory and/or third-party vendor data (eCRF, IRT, SAE, etc.) and 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
- Perform Serious Adverse Event (SAE) reconciliation activities in a timely manner and according to SOPs and WPs
- Track team quality and productivity data
- Apply quality control procedures and checks to ensure data quality standards (client and Accenture) are achieved
- Freeze and/or lock eCRFs (as appropriate) within the Electronic Data Capture System
- Communicate effectively with the study team (e.g
- Trial Data Manager, Project Data Manager, Clinical Trial Team etc.)
- Train and guide less experienced CDCs in data management requirements and activities
- Solving issues through using the global issue escalation /communication plan
- Strictly following core operating procedures and working instructions
- Developing and maintaining good communication and working relationships within CDM team and client
- Interacting with CDM team members to negotiate timelines and responsibilities
- Participating in Learning and development process improvement activities
- Providing ongoing project support in terms of general administration, documentation and filling
- Documentation during the lock activities and multi tasked with a lot of activities like allocated work and then tracked the completion status
Data Manager
Pfizer
08.2021 - 08.2022
- Company Overview: Chennai
- Performs all aspects of the data cleaning process, with leadership skills and in accordance with GCPs and SOPs/WPDs
- Work experience in Inform Database for Vaccination studies
- Good communication skills and interpersonal skills, Mentored resources on study specific activities
- Review and resolve auto queries that have fired in the system
- Perform manual checks as specified in guidelines and protocol, issue manual queries and track, review and close all query responses (Query management)
- Re-issue and close out queries and follow up emails sent to LDM on queries during study close out
- Created the instruction to the site to update specific forms using UAT environment for the site reference
- Worked on Inform database freezing sheet allocation and helped in Freezing the forms
- Managing delivery of projects through full data management, quality, determine resource needs, identify out-of scope work, study conduct and close out
- Independently bringing project solutions to the CDM team
- Serving as back-up for other team members
- Lead data management activities for studies of limited volume or complexity, with support from senior team members
- Ensure effective communication between departments and clients to facilitate smooth execution of study-related data activities
- Help with project forecasting, identify resource needs, and present potential out-of-scope activities to the Project Lead and management
- Mentor junior staff and provide administrative and financial management support for allocated projects
- Chennai
Clinical Data Specialist
IQVIA
01.2020 - 08.2021
- Company Overview: Bengaluru
- Performs all aspects of the data cleaning process, with leadership skills and in accordance with GCPs and SOPs/WPDs Work experience in Inform, RAVE and iMedidata Rave Databases
- Protocol Review, eCRF review, Query Management, Manual Review & Lab Data Management reviewed on multiple projects
- Quick learner, innovative & detail oriented with reputation of unwavering accuracy, credibility & integrity
- A systematic, organized, hardworking & dedicated team player with an analytical bent of mind & quick problem-solving ability
- Excellent communication and interpersonal skills and well-developed Team Interaction skills
- Serving a leadership role for DM tasks
- Serving as Data Operations Coordinator (DOC) for global studies and serving a leadership role for DM tasks
- Managing delivery of projects through full data management study life-cycle
- Managing project timelines and quality; determine resource needs; identify out of scope work
- Develop and maintain good communications and working relationships with CDM team
- Serving as back-up for other team members
- Performing comprehensive data management tasks including data review and resolving data clarifications
- Performing comprehensive quality control procedures
- Independently bringing project solutions to the CDM team
- Solving issues through using the global issue escalation/communication plan
- Assist in developing and implementing new technology
- Understanding and complying with core operating procedures and working instructions
- Meet objectives as assigned, develop, and maintain good communications and working relationships with CDM team
- Interact with CDM team members to negotiate timelines and responsibilities
- Bengaluru
Clinical Data Coordinator II
Quanticate
07.2018 - 12.2019
- Company Overview: Bengaluru
- Performs all aspects of the data cleaning process with minimal supervision and in accordance with GCPs and SOPs
- Key responsibilities are query management, data listing reviews, reconciliation of different external vendors
- Study point of contact for a Phase III study and simultaneously working in 2 studies
- Performing comprehensive data management tasks including discrepancy management, data listing reviews, reconciliation of external vendors
- Provide the study status and metrics as per Sponsor requests
- Performed external vendor reconciliations including Central Lab, ECG and ePRO data
- Understanding and complying with core operating procedures and working instructions
- Meet objectives as assigned
- Serve as a reviewer for Data management documents such as Protocols, eCRF completion guidelines, Data Management plan, Data Review plan, Vendor Data Plan, Data Correction Request logs
- Testing of Data management system edit/ data validation checks and special listings
- Develop and maintain good communications and working relationships with CDM team
- Solving issues through using the global issue escalation /communication plan
- Coordinating with the CRAs to ensure that the sites update the data as per eCRF completion guidelines (CCG) and resolving issues regarding the clinical trial data
- Providing ongoing project support in terms of general DM activities, documentation, and filling
- Supporting lead in DMP documents creation, posting in the client website and updating the eCRF guidelines
- Documentation during the lock activities and multi tasked with a lot of activities like allocated work and then tracked the completion status
- Knowledgeable in SDTM and Pinnacle 21 review
- Validate test steps, Test case creation, development of eCRF to meet the needs of the customer and the clinical trial utilizing protocol and specifications provided at the pre-design meeting
- Briefly worked on SSU activities like UAT testing
- Maintain the documents as per SOP with the updated templates, archival in eTMF with proper digital signatures for any future audits
- Bengaluru
Clinical Data Associate 1
PPD
05.2016 - 06.2018
- Company Overview: Bengaluru
- Performs all aspects of the data cleaning process, with minimal supervision and in accordance with GCPs and SOPs
- Key responsibilities are query close out, data listing reviews, reconciliation of Serious Adverse Events and Central lab reconciliations
- Perform initial review of data discrepancies and database updates
- Performing comprehensive data management tasks including LNR entry, data listing reviews, reconciliation of lab recons, providing Study Metrics and eTMF tasks
- Complete review and validation of clinical data to ensure consistency, integrity and accuracy according to Study specific guidelines
- Understanding and complying with core operating procedures and working instructions
- Performing Listings review for clinically significant data points and issuing queries to the site for clarifications
- Develop and maintain good communications and working relationships with CDM team
- Interact with CDM team members to discuss timelines and responsibilities
- Solving issues through using the global issue escalation /communication plan
- Strictly following core operating procedures and working instructions
- Participating in Learning and development process improvement activities
- Bengaluru
Educational Facilitator
Vibgyor High School
08.2015 - 05.2016
- Responsible for the Sports Activities
- Responsible for preparing study materials for Science Subject
Admin Officer
Vibgyor High School
08.2014 - 05.2016
- Responsible for the daily administrative running and follow-up of the project activities in coordination with the senior management & specialists across zones
- Administering databases, collecting and analyzing research information and verifying the authenticity and dependability of data
- Managing daily office operations and maintenance of equipment and accurate records, influencing team decisions with respect to research directions
- Sustaining safe workplace practice & measures which are subject to review and scrutiny by Health and Safety Legislation
- Monitoring and evaluating experimental research plans; developing written reports; supporting senior faculty in administrative management roles
Research Assistant
St John's Research Institute
08.2012 - 05.2014
- Conducted Biochemical Analysis so as to prepare quality controls for urinary iodine analysis of pregnant women
- Verified sensitivity of urinary iodine assay, inter and intra-assay precision of urinary iodine assay
- Ascertaining the urinary iodine in pregnant women, analytical recovery of urinary iodine assay in clinical samples
- Supervised biological samples like plasma, serum separation from blood and cord blood samples for advanced investigation
- Interpreted and translated documents
- Assisted in the preparation of research reports for the institute
- Created reports on studies based on nestle iodine, urine analysis & blood analysis
- Responsible as a Data Entry Coordinator assisting in the study which intended to evaluate the effect of iodine supplementation during pregnancy in an Indian women
- Engaged in managing & segregation of biological samples
Education
M.Sc. - Biotechnology
P.E.S College
Bangalore01.2009
B. Sc. - Biotechnology
Bangalore01.2007
PUC -
JNC
Bangalore01.2004
Xth STD -
Cambridge Public High School
Bangalore01.2001
Skills
- Ethical, compliant with company's set forth policies
- Leadership skills
- Team facilitator
- Good at interpersonal Skills
- Initiator and Team leading ability
- Highly flexible
- Willingness to learn new things with every opportunity
- Microsoft office applications
- Completed project management course from Udemy
Languages
English
Hindi
Marathi
Kannada
Telugu
Personal Information
Date of Birth: 07/10/85
Awards
- Bronze Award & Ovation Award, 02/01/20, Received for supporting a study.
- DM Spot Award Achievement, 08/01/17, For supporting a study.
- 3rd Place of Quanticate's office Olympics, 07/01/19, In Bangalore.
- Runner up Award for Product Launch, 2019, In Quanticate, Bangalore.
- Certificate of training for Email Etiquette, 09/01/19, In Bangalore.
- Wow Award, 2023, In Accenture.
- Wow Award, 2024, In Accenture.
Skills
C Language, C++, UNIX, Linux, Windows 98, 2000, XP, MS Word, MS Excel, MEDIDATA RAVE, RAVEX, INFORM, Oncology, Vaccines, Atopic Dermatitis, Urology
Timeline
Data Manager II
Accenture Services Pvt Ltd
08.2022 - Current
Data Manager
Pfizer
08.2021 - 08.2022
Clinical Data Specialist
IQVIA
01.2020 - 08.2021
Clinical Data Coordinator II
Quanticate
07.2018 - 12.2019
Clinical Data Associate 1
PPD
05.2016 - 06.2018
Educational Facilitator
Vibgyor High School
08.2015 - 05.2016
Admin Officer
Vibgyor High School
08.2014 - 05.2016
Research Assistant
St John's Research Institute
08.2012 - 05.2014
M.Sc. - Biotechnology
P.E.S College
B. Sc. - Biotechnology
PUC -
JNC
Xth STD -
Cambridge Public High School
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