Anshu Sharma
Bangalore
Summary
Seeking a challenging career, this will enable me to bring out my skills to the benefit of the organization and also to learn mutually from the organization.
I am a programmer with 9 years of experience in Clinical Data Management domain as Developer for EDC system using Oracle InForm, Central Designer, Medidata Rave, RaveX and having good experience in Windows application development. Ensure adherence to various audit and compliance guidelines. Good communication abilities, quick wit, and dedication to work have made me a key contributor in a shorter span.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Senior Clinical Database Programmer
PAREXEL International Pvt Ltd
Bangalore
2021.03 - Current
- Act as the Lead DB Programmer (DBD) for the allocated studies by being the primary POC where the responsibilities include but are not limited to.
- Participate in the KOM/review protocols and draw plans to develop databases independently.
- Actively liaise with the stakeholders (external and internal) to determine study requirements, deliverables and timelines.
- Build eCRF screens as required by the schedule of events in the protocol.
- Program advanced level edit checks, Simple/Medium complex custom functions, dynamics and setup rules and alerts as per the Edit Check Specifications (ECS).
- Demonstrate ability to make study DBs live on time to the satisfaction of all stakeholders.
- Achieve Mid Study Updates (MSU) when necessary to the satisfaction of stakeholders, by performing the impact analysis and making updates in the database.
- Perform database lock (interim/final) in consultation with DML and other stakeholders by tracking the study progress and ensuring the necessary steps are complete for DB lock.
- Demonstrate ability to quickly learn and work with new EDC tools when necessary.
- Effective communications with cross-functional project teams.
Clinical Database Programmer II
PAREXEL International Pvt Ltd
Bangalore
2017.05 - 2021.03
- Work closely with the lead database developer in allocated tasks.
- Contribute to the development and testing of clinical databases in set-up phase.
- Contribute to the process of programming edit checks/dynamics/rules/alerts.
- Contribute to the Mid Study Update (MSU) process when necessary under supervision.
- Act as Lead DBD for the allocated studies by liaising with the stakeholders (external and internal) to determine study requirements, deliverables and timelines under the supervision of the Principal Database Programmer(PCDBP).
- Play active role in making the databases live and contribute to study documentation during the set-up phase.
- Assess the impact of MSU when necessary and implement the changes to live environment.
- Manage the database lock process (interim/final) under the supervision from Senior Clinical Database Developer (SCDBP) or PCDBP.
- Demonstrate ability to learn and work with new EDC tools when necessary.
- Demonstrate reasonable level of understanding of EDC functionalities such as RTSM and assist the SCDBP or PCDBP in the setup of RTSM.
- Program advanced-level edit checks and rules.
- Effective communications with cross-functional project teams
- Contribute to the delivery of a clean clinical database
Clinical Database Programmer I
PAREXEL International Pvt Ltd
Bangalore
2016.07 - 2017.04
• Annotate CRFs, configure paper databases and eCRF, visit schedules, and edit checks.
• Based on the specifications, designing standard and non-standard eCRFs and generating a logical edit check program to find the data inconsistency for EDC studies.
• Perform the necessary quality control steps to confirm the study is built in accordance with approved specifications.
• Develop custom functions for Central Designer studies
• Resolve and update issues arising from QC/UAT, including study databases, eCRFs, and edit checks.
• Identify design issues, provide recommendations, and advise the study designer in a timely fashion. Also, provide feedback and suggestions for improvements to the design specifications or process.
Associate Clinical Data Management Programmer
inVentiv Health
Pune
2014.06 - 2016.06
- The project involves configuration of databases for EDC studies, annotate CRF's and develop edit checks programming to validate the clinical data.
Education
M.C.A - Computer Application
Jain College of MCA And MV+BA
Belgavi01.2014
B.C.A - Computer Application
RLS College of BCA
Belgavi01.2011
H.S.C. -
Kendriya Vidyalaya
Belgavi01.2008
S.S.C. -
Kendriya Vidyalaya
Adampur01.2006
Skills
- Win 2003/XP/7/10
- C, C#, VB macros
- CRS Cube EDC
- Oracle InForm
- Medidata Rave
Accomplishments
- Received recognition in the PAREXEL Manager Discretionary Program by LM for exhibiting the Teamwork PAREXEL corporate value or High Performance Culture principle.
- Received recognition in the PAREXEL Colleague Recognition program by the Data Manager Lead for exhibiting the I Delight the Customer PAREXEL corporate value or High Performance Culture principle.
- Received recognition in the Manager Discretionary Program by LM in the category of ownership.
- Received recognition in the Colleague Recognition program by Account Lead in the category of client service and quality.
- Rani Chinamma University Silver medalist in MCA.
Process Improvement Initiatives
Actively involved in process improvement (software development) discussions and developed tools which improve the quality of the deliverables and reduce efforts., VB.net, Visual Studio 2012, Developed an application which is used create study from MDR for the standard. This tool is taking the Organization DVS and compares the content of the DVS with the ALS and the Config Specification from Medidata Rave. It will ensure that all edit checks specified in the DVS are also implemented in the study and vice versa. The RVToolbox is currently in development and is focusing on the interface between the Parexel Metadata Repository (MDR) and the Rave Architect Loader Sheet (ALS)., C#, Visual Studio 2008, Developed an application to compare two CSML files and the output will show the difference between two CSML files in excel and word format.
Professional Highlights
eCRFseCRFs
- I am a key contributor in the configuration of databases for EDC studies, which includes form designing (eCRF Development) and logical edit check programming using Medidata Rave, Central Designer 2.0 and 2.1 versions.
- Program and configure simple and complex eCRF behaviors (Dynamics) within the database depending upon the number of protocols involved in the study structure.
- Setup clinical studies from the scratch in RAVE.
- Configure data validations required for the EDC study with respect to simple and complex Edit checks.
- With respect to any protocol amendments, responsible for making all postproduction changes in the study via Migrations and Publish checks.
- Preparing impact analysis document for the changes requested and explaining the study team about the impact on the live data.
- Ensuring there is no data loss while the migration process.
- Using PDF Generator in Medidata RAVE Tool to generate study related PDF reports.
- Proper communication and coordination with Onsite Team for resolving study related issues.
- Providing solutions in resolving study related issues which require technical expertise.
- Design and develop electronic Case Report Forms for leading Pharmaceutical companies using the EDC tool RAeCRFshese eCRFs are used for electronic data capture from clinical trial sites as well as for data management activities.
- Collaborating with Study Data Manager to understand the Clinical study data flow and suggest the solutions for the study related discrepancies.
- Monitor quality and efficiency across projects to identify trends and opportunities for improvements.
- Having good experience in working with Rave classic.
- Trained in CRSCube.
Personal Information
- Father's Name: Ravindra Pal Sharma
- Date of Birth: 01/25/1991
- Nationality: Indian
- Marital Status: Married
- Religion: Hindu
Languages
Hindi, English
Affiliations
RVTOOLBOX using VB macros(Visual Studio 2012)
- I developed an application which is used create study from MDR for the standard. This tool is taking the Organization DVS and compares the content of the DVS with the ALS and the Config Specification from Medidata Rave.
- It will ensure that all edit checks specified in the DVS are also implemented in the study and vice versa.
- The RVToolbox is currently in development and is focusing on the interface between the Parexel Metadata Repository (MDR) and the Rave Architect Loader Sheet (ALS).
CSML comparator using C# Visual Studio 2008
- Developed an application to compare two CSML files and the output will show the difference between two CSML files in excel and word format
Certification
- Certified medidata
- Certified Oracle Training
- Certified CRS Cube EDC tool
Timeline
Senior Clinical Database Programmer
PAREXEL International Pvt Ltd
2021.03 - Current
Clinical Database Programmer II
PAREXEL International Pvt Ltd
2017.05 - 2021.03
Clinical Database Programmer I
PAREXEL International Pvt Ltd
2016.07 - 2017.04
Associate Clinical Data Management Programmer
inVentiv Health
2014.06 - 2016.06
M.C.A - Computer Application
Jain College of MCA And MV+BA
B.C.A - Computer Application
RLS College of BCA
H.S.C. -
Kendriya Vidyalaya
S.S.C. -
Kendriya Vidyalaya
- Certified medidata
- Certified Oracle Training
- Certified CRS Cube EDC tool
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