Deepan Arunachalam
Clinical Data Svs Specialist
Coimbatore
Summary
trained over 200 professionals in EDC system
trained over 10 professionals in custom functions and RCC CMC programming
Successfully executed auto enrollment project with three team members
Resolved over 50 complex post-production changes, ensuring timely project delivery and high-quality outcomes.
Overview
14
14
years of professional experience
Work History
Clinical Data Svs Specialist
Accenture Limited
01.2025 - Current
- Copy and customize standard objects from the Standard library, as applicable
- Build non-standard Objects from Scratch and ensure it is aligned to Specification, as applicable.
- Coordinate with the client team to finalize the database component and specifications.
- Compile database components, including forms, folders, Matrices, layouts, derivations, validations, edit checks, and Custom functions, according to specifications and client instructions.
- Complete study set-up activities, as expected.
- Provide inputs for finalizing of Migration and conduct impact analysis for migrations and quick publish changes, as expected
- Investigate production issues and provide suggestion to fit it.
- Execute migrations and quick publish changes, as expected.
- Participate in client review meetings to address any Clarifications or suggest an alternate way in case of any technical limitation
- Deploy database into production, if applicable.
- Collaborated with cross-functional teams to achieve project goals on time and within budget.
- Improved customer satisfaction rates through proactive problem-solving and efficient complaint resolution.
Project Management and BE SPOC
Accenture Limited
08.2024 - 01.2025
- Engaged in Failure Mode and Effects Analysis (FMEA).
- Conducted monthly updates of the Business Excellence (BE) document and presented it to the SDLs and managers.
- Incorporated feedback from SDLs and managers to revise the document accordingly.
- Participated in Root Cause Analysis (RCA) and Corrective and Preventive Actions (CAPAs).
- Organized necessary knowledge transfer sessions for the team, emphasizing key focus areas.
- Collaborate with the Process Owners to offer recommendations for updating the Standard Operating Procedures (SOPs) in accordance with the most recent migrations, aiming to simplify processes.
CD, Inform Tool Trainer, Mentor, SME
Accenture Limited
12.2022 - 01.2025
- Facilitate training sessions for newly hired employees and issue certifications upon the successful completion of their training process.
- Provide support and mentorship to new employees while instructing them on operational procedures.
- Arrange refresher training sessions as necessary.
- Effectively address and resolve complex issues.
- Enhance and optimize automation tools.
- Prepare checklists and conduct assessments on technical skills and processes for trainees.
- Oversee critical production studies and offer necessary support.
- Participate in client calls and provide recommendations for post-production modifications.
- Conduct impact analyses to identify potential effects promptly and offer suggestions to the team.
Senior RAVE EDC Programmer
Accenture Limited
09.2022 - 08.2024
- Manage integrations and enhancements, maintain relevant databases. Address Tickets related to database
- Maintain of case Report Forms, Database objects, Forms, Edit checks and Procedures.
- Create test patient position details as per the study design specification and assign patients.
- Copy / Create study database objects such as Forms, Edit checks and Procedures from the Global Library and Customize as per Specification while ensuring consistency in database.
- Perform Self-testing for Database Objects.
- Copy and customize non-Standard objects and Programs from the Global Library, as applicable.
- Build non-Standard Objects from Scratch and ensure it is aligned to specification, as applicable.
- Provide user support, troubleshooting and maintenance of the tools and documentation related to these activities, if required.
- Communicate to Onshore team for the completion of database objects.
- Update the database objects as per the Quality check feedback provided by the client.
- Perform annotation/ database update /quality assurance on case report form (CRF) annotations and blank patient data reports (PDRs) for post-production studies changes, as applicable.
- Participate in UAT when new application releases occur, as applicable.
- Assemble database components (forms, folders, matrices, layouts, derivations, Validations, edit checks and custom functions) as per specifications and client instructions and updates thereto.
- Migrate database, if required.
- Complete study set-up activities, as required.
- Define scope and conduct impact analysis for migrations and post production changes, as required.
- Perform Migrations and post-Production Changes.
- Generate and provide the Annotated and Non-Annotated case report forms.
- Deploy database, as required.
Senior Clinical Data Base Developer
Accenture Limited
11.2019 - 09.2022
- Copy and customize standard objects from the Standard library, as applicable
- Build non-standard Objects from Scratch and ensure it is aligned to Specification, as applicable.
- Coordinate with the client team to finalize the database component and specifications.
- Compile database components, including forms, folders, Matrices, layouts, derivations, validations, edit checks, and Custom functions, according to specifications and client instructions.
- Complete study set-up activities, as expected.
- Provide inputs for finalizing of Migration and conduct impact analysis for migrations and quick publish changes, as expected
- Investigate production issues and provide suggestion to fit it.
- Execute migrations and quick publish changes, as expected.
- Participate in client review meetings to address any Clarifications or suggest an alternate way in case of any technical limitation
- Deploy database into production, if applicable.
INNOVATION LEAD: AUTOMATION TOOLS AND CUSTOMFUNCTIONS
Cognizant Technology Solutions
10.2017 - 11.2019
- As part of my responsibilities I have to create a Tools/Function which is requested by client in the short time interval
- Working on process for “process improvement and Automation”.
- Ensured the timely completion of project development tasks to meet all project timelines well ahead of expectation by using process customization/improvement techniques.
- Implement and test the functionality is working as expected
- Provide Process Improvement Ideas
- DEMO Session for new Functions/Tools with client along with team members and managers, and explain the functionality, address all the questions.
- Standardize the work and automation
- Motivate the team members for Innovation with KT Sessions
- Providing Ideas and make team members to initiate the tool and make it complete.
- .Net Training to the team (initial training for Custom function creation, Windows application ,etc..)
- SQL Training to the team (Eg: Complex join, other Complex sql query, etc.. )
- Edit check training to the team (Eg: Complex dynamic rules, grid with repeating form comparison Edit checks, etc...)
STUDY SETUP TEAM MANAGEMENT AND PROGRAMMING
Cognizant Technology Solutions
04.2015 - 10.2017
- As part of my responsibilities, I am leading the team of programmers (Six).
- Develop study set up as per the requirement.
- Taking training for new joiners/Team Members and knowledge sharing sessions.
- Writing and reviewing the Edit check as per the Project structure.
- Guide the Team to develop the edit check programming according to Project Plan and Design in central Designer.
- Guide the Team to perform Validation and Unit testing of project.
- Guide the Team to create new function and Procedures for database.
- Supporting Team members for the Development and Testing for timely completion of tasks.
- To Work with the Data Managers for resolving their queries.
- Support new employees on database management procedures and systems.
- To ensure timely completion of Post production and library management change requests/ TCR (Trial Correction Request) Requests as part of Post-Production Change
- Active Participation in the knowledge sharing process.
- Perform the duties of the Data Management database support to specialist to ensure minimum downtime and quick problem resolution.
- To Train new employees on database management procedures
- To assist with the programming and testing of automated edit checks for new studies.
- To perform communication with Clients about project status and regular updates of the project.
DATABASE CED CLINICAL REPORT PROGRAMMER
Cognizant Technology Solutions
02.2013 - 04.2015
- To perform review of database design documents and Database Structure documents and Review the requirements
- To Design the forms according to the Database Structure, test, and maintaining of the project database, and the definition of data entry conventions.
- To perform Validation of project and Unit testing.
- To set-up external data import and validation as per agreed specifications.
- Provide technical expertise to the Data management team.
- To assist in database release activities.
- To file project documentation.
- To identify, communicate and resolve data issues on a timely manner.
- To implement defined quality control procedures as per DM Plan.
- To assist in system validation activities.
- To liaise with other project team members.
- To be involved in development and maintenance of SOPs.
- To Train new employees on database management procedures
- Develop the Reports based on the Clinical Requirements.
STUDY SETUP PROGRAMMER
Cognizant Technology Solutions
10.2011 - 02.2013
- Ensured the timely completion of project development tasks to meet all project timelines well ahead of expectation by using process customization/improvement techniques.
- Writing and reviewing the Edit checks as per the Project Requirements.
- To develop the edit check programming according to Project Plan and Design in central Designer.
- To perform Validation and Unit testing of project.
- To create new functions
- Develop the eCRFs & Edit checks as per the Clinical Requirements.
- Supporting Team members for the Development and Testing for timely completion of tasks.
- To Work with the Data Managers for resolving their queries.
- Support new employees on database management procedures and systems.
- To ensure timely completion of Post production and library management change requests.
- Active Participation in the knowledge sharing process.
- Perform the duties of the Data Management database support to specialist to ensure minimum downtime and quick problem resolution.
Education
MBA - Information System Management
Bharathiyar University, Hindustan College
Coimbatore, Tamilnadu, India06-2022
Bachelor of Science - Information Technology
Bharathiyar University, Dr.N.G.P ASC College
Coimbatore, Tamilnadu, India06-2010
Diploma - Computer Application (DCA)
CSC Computer Education
Coimbatore, Tamilnadu, India06-2009
Skills
EDC software knowledge Medidata Rave functionality Data evaluation and processing
Data management architecture
Script development
Task coordination
clinical trial management
Resource efficiency
Information sharing
Diagnostic skills
C# software development Console applications Excel integration with VBA SQL database programming
Collaboration tools
incident response
Key performance indicators (KPIs)
Problem source analysis
Operational leadership
Client interaction strategy
Collaborative teamwork
Timeline
Clinical Data Svs Specialist
Accenture Limited
01.2025 - Current
Project Management and BE SPOC
Accenture Limited
08.2024 - 01.2025
CD, Inform Tool Trainer, Mentor, SME
Accenture Limited
12.2022 - 01.2025
Senior RAVE EDC Programmer
Accenture Limited
09.2022 - 08.2024
Senior Clinical Data Base Developer
Accenture Limited
11.2019 - 09.2022
INNOVATION LEAD: AUTOMATION TOOLS AND CUSTOMFUNCTIONS
Cognizant Technology Solutions
10.2017 - 11.2019
STUDY SETUP TEAM MANAGEMENT AND PROGRAMMING
Cognizant Technology Solutions
04.2015 - 10.2017
DATABASE CED CLINICAL REPORT PROGRAMMER
Cognizant Technology Solutions
02.2013 - 04.2015
STUDY SETUP PROGRAMMER
Cognizant Technology Solutions
10.2011 - 02.2013
MBA - Information System Management
Bharathiyar University, Hindustan College
Diploma - Computer Application (DCA)
CSC Computer Education
Bachelor of Science - Information Technology
Bharathiyar University, Dr.N.G.P ASC College