Lavanya Kannan
Clinical Data Manager
Hosur
Summary
- Over 16 years and 11 month of experience working in Clinical Research Industry (CRO) performing Data Management Process.
- Clinical Research Therapeutic Areas include: Neoplasms Benign, Malignant and Unspecified Metastatic Urothelial Carcinoma: Phase III study Metastatic Non-Small Cell Lung Cancer: Phase III study Stage IV Non-Small Cell Lung Cancer: Phase II study Hepatocellular Carcinoma: Phase I study Advanced Solid Tumor: Phase I Study Advanced Gastric or GEJ Adenocarcinoma: Phase III study Local or Advanced Metastatic Breast Cancer: Phase Ia/Ib study Endocrine Disorders Diabetes Mellitus Type 2: Phase IV Study Diabetes Mellitus Type 2: Phase III Study Diabetes Mellitus Type 2: Phase II Study Biological Study: Psoriasis /Atopic Dermatitis - Phase II and Phase III RA Study - Phase II
- Systems/Computer skills include : MS office, Windows XP, Internet applications
- Experience in Electronic Data Capture Trials: OCRDC, RAVE, InformTM V6.2, Veeva Vault EDC, Datatrack
- Data Visualization Tools: Jreview, Spotfire,Tableau Metrics Dashboard, Trialmanager, Transportal (translation process)
- Languages known: Tamil (verbal and written), English (verbal and written)
Overview
17
17
years of professional experience
3
3
Languages
Work History
Group Leader
ICON Clinical Research
08.2024 - Current
- As a Group Lead/Line Manager, to recognize the importance of and create a culture of process improvement with maximum focus on streamlining our processes adding value to our business and meeting client needs
- Effectively managing resourcing of central filing staff to ensure Data Coordinators activities are performed as per established process, timeframes and quality standards and that targets are met to the Operations team and sponsor's satisfaction
- Line management and leadership of team including, setting appropriate goals and objectives; offering assistance and mentoring to team members wherever appropriate to create a supportive working environment; developing effective working relationships with the team engendering an atmosphere of motivation, creativity and innovation whilst providing opportunities for learning and development within the team
- Recognize, exemplify and adhere to company values, which centre on our commitment to People, Clients and Performance
- As a member of staff, we to embrace and contribute to our culture of process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs
- Ensure DM teams achieve productivity and quality targets, perform benchmarking reviews and perform oversight of deliverables using different tools/techniques and maintain and report relevant metrics
- Work with groups/teams to determine the best method of resolving indexing and filing errors or inconsistencies and provide regular performance feedback to team
- Capture user feedback on central filing activities
- Participate in the modification of systems, process and training as required by pilot results
- Represent DM Operations during internal/external/sponsor audits and manage findings through effective resolution both operationally and within the Quality Management System
- Manage the performance of the DM group vis-à-vis established timeliness, budget, quality standards and/or contractual requirements during the pilot phase and post pilot phase
- Keep senior management informed of any human resource related issues within the organisation which require attention
- Monitor employee absences and continue to ensure absenteeism is kept within acceptable limits
- Support project management of activities supported in all locations, liaise with project/study teams, functional groups/clients and escalate issues to local/senior management and global study teams in a timely manner
- To competently process study documents in accordance with client and study requirements as per study-specific processes, ICON SOPs/WPs and regulations, where applicable
- To inform the Manager of training issues, project activities, quality issues and timelines as directed
Clinical Data Science Lead
ICON Clinical Research
08.2021 - 07.2024
- Takes a leadership role with the CRO, the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s)
- With the trial customer, CRO and other functional partners: Gathers content and integration requirements for eCRF and other data collection tools
- Establishes conventions and quality expectations for clinical data
- Establishes expectations for dataset content and structure
- Set timelines and follow-up regularly to ensure delivery of all Data Management milestones
- Performs trial level oversight controls as described in the oversight plan, QC process and work instructions with minimal DML direction
- Reviews clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency
- Ensures compliance with regulatory guidelines and the documentation matrix
- Ensures real-time inspection readiness of all IDS deliverables for the trial; Participate in Regulatory Agency and internal audits as necessary
- Plans and tracks content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival
- Ensures deliverables are on time
- Takes a leadership role with the assigned clinical working group(s) to ensure that IDS and TA trial needs and deliverables are met
- Identifies and communicates lessons learned, best practices and frequently asked questions at the trial level
- Identifies and participates in process, system, and tool improvement initiatives within IDS
- Presents and trains at investigator and monitor meetings
Senior Clinical Data Coordinator
ICON Clinical Research
04.2017 - 07.2021
- Read, ensure understanding and adhere to all assigned ICON SOPs and working procedures
- Ensure all work performed is of high quality, compliant with Good Clinical Practice, ICH Guidelines and all applicable laws and regulations
- Review eCRF data for completeness, accuracy, and consistency via computerized edits and manual data checks
- Identified as a primary POC for review of some of the critical panels in oncology trial and trained peers of the team in understanding the same
- Identify and appropriately address data discrepancies in the clinical data via computerized edits and manual checks/listings
- Perform external data reconciliation.(IWRS, eCOA, Lab)
- Perform Serious Adverse Event reconciliation
- Perform Adjudication reconciliation and communication with Adjudication team and CRA
- Generate and close/resolve (as appropriate) data queries
- Freeze and/or lock eCRFs (as appropriate) within the Electronic Data Capture System
- Create and distribute study metrics and status updates to respective stakeholders/trial team
- Provide feedback on timelines and metrics for a holistic and realistic data/status update to the team
- Create and maintain study files and other appropriate study documentation
- Perform User Acceptance Testing (writing test scripts, system testing edit check testing, and mDVP specifications) and collaboratively work with CDMS personnel to see issues found are fixed through re-testing and resolution
- Perform validation of edit check programs
- Develop, review and update Data Management Study Specific Procedures including Edit Check Specifications
- Assist Data Management Study Lead in development of eCRF, Data Validation Specification, and Study Specific Procedures
- Assist CDLs for Study build task (eCRFi writing, mDVP creation, EECS updates, testing plan for UAT)
- Train and guide less experienced or new CDCs in data management activities and trial specific requirements
- Providing feedback about resource to line managers
- Coordinating and handling clinical trials as the primary POC in the data management portfolio
- Performing Co-CDL role for both the studies assigned
- Managing study timelines and activities by coordinating with trial team here and the onshore team by performing allocation of tasks to the team appropriately
- Coordinate with clinical, medical team to get the tasks completed from these teams and support them with information or other tasks required from the Data management team
- Assist the trial CDL with activities such as UAT, study build, PPC, mDVP updates and ad-hoc reviews (ex: listings from Statistics and medical teams) during timelines
- Represent Data Management at internal external meetings as appropriate
- Perform other project activities as required in order to ensure that study timelines are met (for example, filing and archiving of study documentation, dispatching of queries to investigator sites for resolution, etc.)
- As required, communicate effectively with the Project team, Study Lead, Project Lead and Project Manager
Clinical Data Coordinator II
ICON Clinical Research
04.2015 - 03.2017
- Independently and accurately review Case Report Form data for completeness, accuracy and consistency in accordance with all applicable procedures
- Accurately and consistently apply data handling conventions to Case Report Forms as necessary in accordance with all applicable procedures
- Perform Quality Reviews and appropriately address all issues
- Compile and distribute necessary study documentation and maintain accurate and complete study files in accordance with all applicable procedures
- Identify and appropriately address data discrepancies in the clinical data via computerized edits and manual checks/listings
- Independently and accurately generate data queries to resolve data discrepancies
- Appropriately address responses to data queries and accurately update the clinical data as necessary
- Identify and accurately resolve all workflow or clinical data discrepant issues
- Independently and accurately prepare database test documentation and test data entry screens
- Assist with the validation of edit check programs
- Assist with the development, review and the update of relevant Data Management Study Specific Procedures
- Accurately perform Serious Adverse Event reconciliation in accordance with all applicable procedures
- Accurately perform external data reconciliation in accordance with all applicable procedures
- Generate, review for accuracy and distribute status reports as requested
- Assume study lead role when applicable
- Represent Data Management at internal / external meetings as appropriate
- Effectively mentor less experienced staff
- This may include assisting and guiding new personnel during their initial training period
Clinical Data Coordinator I
ICON Clinical Research
04.2012 - 03.2015
- Independently and accurately review Case Report Form data for completeness, accuracy and consistency in accordance with all applicable procedures
- Accurately and consistently apply data handling conventions to Case Report Forms as necessary in accordance with all applicable procedures
- Perform Quality Reviews and appropriately address all issues
- Compile and distribute necessary study documentation and maintain accurate and complete study files in accordance with all applicable procedures
- Identify and appropriately address data discrepancies in the clinical data via computerized edits and manual checks/listings
- Independently and accurately generate data queries to resolve data discrepancies
- Appropriately address responses to data queries and accurately update the clinical data as necessary
- Identify and accurately resolve all workflow or clinical data discrepant issues
- Independently and accurately prepare database test documentation and test data entry screens
- Assist with the validation of edit check programs
- Assist with the development, review and the update of relevant Data Management Study Specific Procedures
- Accurately perform Serious Adverse Event reconciliation in accordance with all applicable procedures
- Accurately perform external data reconciliation in accordance with all applicable procedures
- Generate, review for accuracy and distribute status reports as requested
- Assume study lead role when applicable
- Represent Data Management at internal / external meetings as appropriate
- Effectively mentor less experienced staff
- This may include assisting and guiding new personnel during their initial training period
Assistant Clinical Data Coordinator
ICON Clinical Research
09.2008 - 07.2012
- Accurately review Case report form data for completeness, accuracy and consistency in accordance with all applicable procedures
- Identify and appropriately address data discrepancies in the clinical data via computerized edits and manual checks/listings
- Accurately generate data queries to resolve data discrepancies
- Appropriately address responses to data queries and accurately update the clinical data as necessary
- Accurately and consistently apply data handling conventions to case report forms as necessary in accordance with all applicable procedures
- Perform quality review and appropriately identify all issues
- Compile and distribute necessary study documentation and maintain accurate and complete study files in accordance with all applicable procedures
- Perform other duties reasonably related to the position as directed by manager/designee
Process Associate
Accenture Services Private Limited
11.2007 - 08.2008
- Data Entry of clinical data into Oracle database
- Handling of correction copy of CRF pages and tracking of discrepancies identified
- Data Validation and Study Files Management
- Generate queries to review and resolve data discrepancies
- Processing the Clinical Trial documents as per the regulations of CFR part 54
- Indexing the Clinical Trial documents into ESF, Archiving/Retrieving the documents from study start to study end
- Assist in identifying, assessing and resolving complex issues and problems relating to the documents
- Responsible for quality review of essential documentation and record management of those documents
Education
Master of Science - Biotechnology
Vels College
ChennaiBachelor of Science - Microbiology
Prince Arts and Science College
ChennaiSkills
Data Management Process
Clinical Research Therapeutic Areas
Systems/Computer skills: MS office, SharePoint application, workday tool, EDC application
Electronic Data Capture Trials: OCRDC, RAVE, InformTM V62, Veeva Vault EDC, Datatrack
Data Visualization Tools: Jreview, Spotfire, Tableau Metrics Dashboard, Trialmanager, Transportal
Languages: Tamil (verbal and written), English (verbal and written)
Disclaimer
I hereby declare that all the information I provided above is correct to the best of my knowledge and belief.
Timeline
Group Leader
ICON Clinical Research
08.2024 - Current
Clinical Data Science Lead
ICON Clinical Research
08.2021 - 07.2024
Senior Clinical Data Coordinator
ICON Clinical Research
04.2017 - 07.2021
Clinical Data Coordinator II
ICON Clinical Research
04.2015 - 03.2017
Clinical Data Coordinator I
ICON Clinical Research
04.2012 - 03.2015
Assistant Clinical Data Coordinator
ICON Clinical Research
09.2008 - 07.2012
Process Associate
Accenture Services Private Limited
11.2007 - 08.2008
Master of Science - Biotechnology
Vels College
Bachelor of Science - Microbiology
Prince Arts and Science College