Manager Data
Resume:
PROFILE
Seven years experience in data handling.
Expertise working in different EDC platforms and using SAS based tools.
Proficient in defining and validating protocols for clinical studies and handling trial responsibility throughout the data-management lifecycle.
Well-versed in cGCP and regulatory standards and knowledgeable in therapeutic indications.
PROFESSIONAL EXPERIENCE
TATA CONSULTANCY SERVICES MARCH 2014 – MARCH 2016
STUDY DATA MANAGER Bangalore, India
Represent Data Management (DM) in the Clinical Project Team and act as a coordinator of DM activities in clinical studies across HPV, Zoster and Life Cycle Management projects.
Initiate the CRF design work flow and coordinate review and change management of the CRF along with the study team until CRF finalization.
Work along with the programming team to set up data capture application in accordance with protocol, CRF and coordinate UAT with the programming and clinical teams.
Responsible for creation and updating of DMP (Data Management Plan), CRF completion guidelines and Edit Checks Specifications, Edit Checks Testing and Validation in coordination with the study team.
Accountable to ensure quality and efficiency of Data Cleaning/Discrepancy Management of paper-based and EDC projects according to the SOPs to ensure compliance with the study protocol.
Act as advisor to the study team on data management strategy (study set up, feasibility analysis, data management options, EDC management, query management, feedback on data quality, lab reconciliation, data cleaning timelines etc) throughout the study.
During execution, monitor quality, timings and compliance and take appropriate measures regarding staffing, training, prioritization and escalate concerns where required.
Perform lab reconciliation activities by liaising with lab staff and site managers to resolve any discrepancies.
Ensure review and proper archiving of data management related documentation in the Trial Master File.
Responsible for QC of the cleaning activities performed by clinical data reviewers and provide training/coaching where required.
Track and provide continuous feedback to study team on cleaning progress, timelines, feasibility, problem sites and issues in data quality to study team.
Provide any required training/coaching to site staff with regard to use of EDC or questions on CRF completion.
Responsible to ensure a complete and correct Data Management Report is provided to the study team prior to analyses. This involves ensuring correct assignment of elimination codes as per the specifications set forth by statistical team and also documenting any deviation or issues in data management which may have an impact on study report.
Coordinate Pre Analysis meeting with the study team and follow up on any outstanding issues prior to database lock.
Client facing role which involves planning for and delivering targets, in coordination with a global team.
Provide training, mentoring and competency assessments for new joiners and also work continuously to learn new skills and competencies utilizing offered trainings, coaching plans and e-learnings.
GLAXOSMITHKLINE VACCINES OCTOBER 2013-MARCH 2014
STUDY DATA MANAGER Bangalore, India
Represent Data Management (DM) in the Clinical Project Team and act as a coordinator of DM activities in clinical studies across HPV, Rotavirus, Hepatitis, Combination vaccine projects.
Initiate the CRF design work flow and coordinate review and change management of the CRF along with the study team until CRF finalization.
Work along with the programming team to set up data capture application in accordance with protocol, CRF and coordinate UAT with the programming and clinical teams.
Responsible for creation and updating of DMP (Data Management Plan), CRF completion guidelines and Edit Checks Specifications, Edit Checks Testing and Validation in coordination with the study team.
Accountable to ensure quality and efficiency of Data Cleaning/Discrepancy Management of paper-based and EDC projects according to the SOPs to ensure compliance with the study protocol.
Act as advisor to the study team on data management strategy (study set up, feasibility analysis, data management options, EDC management, query management, feedback on data quality, lab reconciliation, data cleaning timelines etc) throughout the study.
During execution, monitor quality, timings and compliance and take appropriate measures regarding staffing, training, prioritization and escalate concerns where required.
Perform lab reconciliation activities by liaising with lab staff and site managers to resolve any discrepancies.
Ensure review and proper archiving of data management related documentation in the Trial Master File.
Responsible for QC of the cleaning activities performed by clinical data reviewers and provide training/coaching where required.
Track and provide continuous feedback to study team on cleaning progress, timelines, feasibility, problem sites and issues in data quality to study team.
Provide any required training/coaching to site staff with regard to use of EDC or questions on CRF completion.
Responsible to ensure a complete and correct Data Management Report is provided to the study team prior to analyses. This involves ensuring correct assignment of elimination codes as per the specifications set forth by statistical team and also documenting any deviation or issues in data management which may have an impact on study report.
Provide training, mentoring and competency assessments for new joiners and also work continuously to learn new skills and competencies utilizing offered trainings, coaching plans and e-learnings.
GLAXOSMITHKLINE VACCINES DECEMBER 2010 – OCTOBER 2013
DATA MANAGER-SENIOR ASSOCIATE Bangalore, India
Responsible for validating data encoded clinical data using the in-house tool- ‘WEB-ENABLE’ to ensure that no discrepancies or missing information exist before the data is analyzed.
Assist Study Data Manager in developing Data Cleaning Guidelines and reviewing the CRF completion guidelines.
Provide assistance to site staff with regard to the use of EDC systems and CRF completion when required.
Manage discrepancies in clinical data through queries and following up with site staff for resolution on a timely basis.
Responsible for lab data reconciliation by liaising with site staff, lab staff and study managers, with inputs from the Study Data Manager.
Parameterization of the SAS batches at the start of the automatic cleaning and performing coding of adverse events and medications terms.
Perform manual review of data through listings generated via SAS batches.
Review the Edit-Check Specification document and performing the UAT of edit checks in Inform.
Responsible to highlight to Study Data Manager any lags in query resolution or any possible blocks in meeting set timelines.
Suggest feedback or possible solutions to any issues by providing feedback to the Study Data Manager or Project Data Manager.
Preparing Data Management Report for the Pre-Analysis Meeting by assigning elimination codes as per the specifications set forth by statistical team.
Responsible to post all relevant data management documents handled by CDR into the documents repository and ensure it is validated by signatories.
Responsible for resolution of database correction request forms after DB lock.
Train and mentor new joiners and provide feedback to team leads.
Ensure a clean and consistent database for statistical analysis.
BIOBASE-BIOLOGICAL DATABASES PVT LTD AUGUST 2007 – OCTOBER 2008
SCIENTIFIC DATA CURATOR Bangalore, India
Curating scientific literature to identify protein-protein interactions.
Providing high quality data in accordance with deadlines and SOPs.
Constant communication with onsite and offshore team to update and maintain the standards of the database.
Quality check and UI testing.
Raising and resolving any queries regarding data.
Mentoring junior resources.
JUBILANT BIOSYS JULY 2006 – JULY 2007
RESEARCH ASSOCIATE Bangalore, India
Curating scientific literature and patents to identify protein-protein, drug- protein and other interactions. Worked on COPD, Cardiovascular diseases and product development for different pilot projects.
Maintaining quality of data through data review, data clean-up.
Delivering high quality data output within specified timelines and in accordance with client and company SOPs.
Generating pathways on the basis of protein-protein, gene-protein and other interactions.
Product development for pilot projects as per customer requirements.
Template designing for data entry.
EDUCATION
Advanced Diploma in Clinical Research and Clinical Data Management: from ICBio, Bangalore.
MSc. Biotechnology: from R.V.S College of Arts and Science (Autonomous affiliated to Bharathiyar University), Coimbatore, Tamil Nadu in April 2006.
Bsc. Biotechnology: from Maharaja College For Women (affiliated to Bharathiyar University), Perundurai, Erode in April 2004.
CERTIFICATIONS AND AFFILIATIONS
SAS Certified Base Programmer for SAS 9
PROFESSIONAL ACHIEVEMENTS
Received Award of Excellence for outstanding work on a Hib vaccine pediatric trial.
Received certificate of Excellence for commitment and excellence as Study Data Manager for HPV vaccine clinical trials.
Received certificate and award for commitment and excellence as Study Data Manager for Zoster clinical trials.
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