SONU DIXON
Senior Data Manager
Summary
Well-qualified Clinical Data Manager prepared to offer 10+ years of clinical data management experience to fast-paced position with room for advancement. Successful at building and maintaining secure, accurate and efficient data collection systems. Dedicated to using excellent research, investigation, and project management abilities to optimize management, organization, and reporting of clinical data. Results-driven, precise, and systematic with quick learning and collaborative nature. Possess extensive project planning and project management experience. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
11
11
years of professional experience
5
5
years of post-secondary education
Work History
Senior Data Manager
Novo Nordisk
Bangalore
11.2019 - Current
- End-to-end trial delivery from DM in accordance with project goals, plans and assigned activities.
- Skilled in developing and implementing data strategies to ensure data accuracy and integrity
- Experienced in data analysis and data visualization to identify trends and patterns
- DM related project management and oversight of the end-to-end clinical trial (s). DM related project risk identification, issue prevention and resolution, decision facilitation and management reporting.
- Experienced in working with cross-functional teams to ensure timely and accurate data delivery
- Skilled in developing and implementing data management plans.
- Proficient in using EDC systems such as Oracle Clinical, DMW and InForm.
- Wrote work instruction manuals, data capture guidelines and standard operating procedures.
- Assisted with database upgrades and migrations by performing user acceptance testing.
- Created plans and communicated deadlines to complete projects on time.
- Used critical thinking to break down problems, evaluate solutions and make decisions.
- Collaborated closely with physicians and nursing staff to improve quality of patient records documentation.
- Participated in committees to discuss electronic health records and methods to improve overall workflows.
- Built and deployed plans, reports, validation procedures and entry processes for data management needs.
Clinical Data Manager
Novo Nordisk
Bangalore
09.2016 - 10.2019
- Coordinating and supporting the main Data Management roles for the trial
- Performing Data handling activities including timely completion of discrepancy management by following appropriate regulatory guidelines, company, and department Standard Operating Procedures (SOPs)
- Worked with programming to coordinate Study Data Tabulation Model as built and deployed plans, reports, validation procedures and entry processes for data management needs
- Assisted with database upgrades and migrations by performing user acceptance testing.
Clinical Data Coordinator
ICON PLC
Chennai
01.2015 - 08.2016
- Developed project-specific data management plans that address areas such as data coding, reporting, or transfer, database locks, and workflow processes
- Generating data queries based on validation checks or errors and omissions identified during data entry to resolve identified problems
- Performing quality control audits to ensure accuracy, completeness, or proper usage of clinical systems and data
- Monitoring work productivity or quality to ensure compliance with standard operating procedures
- Conferring with end users to define or implement clinical system requirements such as data release formats, delivery schedules, and testing protocols
- Preparing data analysis listings and activity, performance, or progress reports
- Supervising the work of data management project staff
- Evaluating processes and technologies, and suggest revisions to increase productivity and efficiency
Assistant Clinical Data Coordinator
ICON PLC
Trivandrum
01.2014 - 01.2015
- Independently and accurately review Case Report Form data for completeness, accuracy and consistency in accordance with all applicable procedures such as data handling conventions
- Performed Quality Reviews and appropriately address all issues
- Identify and appropriately address data discrepancies in the clinical data via edit checks and manual checks/listings
- Independently generate and address responses to data queries or clinical data discrepant issue
- Assisted with the validation of edit check programs and development, review, update of relevant Data Management Study Specific Procedures
- Generate, review and distribute status reports as requested
Central Data Entry Specialist
ICON PLC
Trivandrum
03.2012 - 01.2014
- Independently and accurately perform clinical data entry of updated or new data into RighTrack II CDMS (Clinical Data Management System)
- Performed TMF Safety Due Diligence work which include review of essential documents and protocol review in several databases
- Worked as PTMF Document Owner and Management of the TMF
- Submitting trip reports to Document Management Team for filing reports in various TMF databases
- Worked with the Investigators Payment Grant group which includes updating Supplier Setup Beneficiary Form Tracking
Education
Post Graduate Diploma - Clinical Research
Focus Educare
Chennai 01.2010 - 01.2011
Bachelor of Technology - Biotechnology
Sathyabama University
Chennai 01.2005 - 01.2009
Skills
Discrepancy Management
undefinedTimeline
Senior Data Manager
Novo Nordisk
11.2019 - Current
Clinical Data Manager
Novo Nordisk
09.2016 - 10.2019
Clinical Data Coordinator
ICON PLC
01.2015 - 08.2016
Assistant Clinical Data Coordinator
ICON PLC
01.2014 - 01.2015
Central Data Entry Specialist
ICON PLC
03.2012 - 01.2014
Post Graduate Diploma - Clinical Research
Focus Educare
01.2010 - 01.2011
Bachelor of Technology - Biotechnology
Sathyabama University
01.2005 - 01.2009
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