Cricket - Won the Bundesliga Championship in 2022, Berlin, Germany
Harsha Gopireddy
Medidata Classic RAVE/Rave EDC|®Certified Professional
Berlin
Summary
A passionate and highly motivated programmer with over 14 years of extensive experience in developing and managing trial-specific database applications. I have a proven track record of driving innovation and transformation, leveraging industry-leading tools such as Medidata RAVE/RAVE EDC and VIEDOC to optimize processes and enhance efficiency
Overview
15
15
years of professional experience
3
3
Certifications
2
2
Languages
Work History
Research Development & Sciences
CSL Behring
Berlin (Remote)
03.2024 - Current
- CSL Standards: Worked on Standard Global Library for eCRFs, Edit Checks and Custom Functions
- MDR/SEC: Run ALS in MDR tool to make sure all the Forms/Fields/Visits/Checks/Dynamics managed and accurate execution of all clinical studies
- Protocol: To review the study protocol and to help and maintained the DVS, Dynamics specifications
- Validation: A separate validation tool exists as a standard to run all the eCRF specs, DVS specs, Dynamics spec to correct the things in a proper way
- CDISC -CDASH Standards: Followed CDISC and CDASH standards with restive to study protocol
- USe Sycamore to run prgorams like ALS compare, HTML preview and ACF
Principal Clinical Database Programmer
TFS Health Science
Berlin (Remote)
09.2022 - 01.2024
- Subject Matter Expert/Lead programmer for an assigned study
- Operational Tasks: I actively participated in preparing, conducting, and completing Clinical Data Management tasks in accordance with company policies and standard operating procedures (SOPs)
- Client Deliverables: I meticulously planned and managed client deliverables, ensuring timely and accurate execution of all clinical trials within the Electronic Data Capture (EDC) system
- Database Validation: Collaborating closely with the Clinical Data Manager, I reviewed and validated the Database Validation Plan (DVP) to ensure data accuracy and integrity
- Escalations and System Validation: In cases of SOP deviations-, I handled project escalations. Additionally, I maintained comprehensive test script documentation for system validation, including User Acceptance Testing (UAT)
Principal Clinical Programmer
CLINIPACE
Berlin (Remote)
01.2021 - 08.2021
- Clinical Study Database Management: I meticulously designed, managed, and maintained the clinical study database in strict adherence to protocols, amendments, standard operating procedures (SOPs), good clinical practices (GCP), and other regulatory requirements
- System Specifications and Data Validation: I diligently reviewed, corrected, and developed system specifications, including the Data Validation Plan (DVP). Additionally, I performed programming and core configuration activities for assigned projects and I played a pivotal role in developing and implementing validation procedures for clinical studies, ensuring data accuracy and integrity
- Data Management Plan Contribution: I actively contributed to the Data Management Plan (DMP) and effectively communicated progress on programming milestones to management and other stakeholders
Principal Clinical Database Programmer
CLINTEC, IQVIA
Berlin (Remote)
07.2019 - 01.2021
- As the Accountable Lead for Data Programming, I was responsible for ensuring timely deliverables of all data programming activities within the assigned projects
- Audit Readiness: I meticulously ensured compliance with audit requirements for the projects under my team's purview
- Risk Assessment and Migration: I reviewed study risks and migration plans, providing valuable insights to the team
- Knowledge Sharing and Continuous Improvement: I facilitated lessons learned sessions from various studies, sharing valuable insights across all functions. Additionally, I created Corrective and Preventive Actions (CAPA) and conducted root cause analyses for the studies I was assigned to
- Process Enhancements: I actively participated in process improvement initiatives and contributed to the implementation of new data management systems and tools
Senior Clinical Database Programmer
PAREXEL International
Berlin
10.2014 - 06.2019
- As an experienced professional, I have worked extensively in both Local Labs and Central Labs, handling various aspects related to data management
- Data Stream Management: I managed data streams containing vendor data for the projects assigned to me
- Global Library Reports: I designed, developed, and executed standards for global library reports, ensuring consistency and accuracy
- Quality Control Processes: I implemented quality control processes during the design phase of assigned projects, ensuring data integrity and adherence to standards
- Dictionary Loading: I supported the loading of specific dictionaries in development areas, optimizing data handling and analysis
Clinical Database Programmer I/II
PAREXEL International
Hyderabad
03.2010 - 08.2014
- Database Programming: I Programmed, and rigorously tested databases in accordance with established programming standards
- SDLC Participation: Throughout all phases of the Software Development Life Cycle (SDLC), I actively engaged to gain a comprehensive understanding of project activities
- Global Library Object Requests: I meticulously analyzed requests for adding objects to global libraries, ensuring alignment with project requirements
- Data Management Support: I provided essential support to the Data Management team, Statistical Programmers, and Clinical staff. This included ongoing database maintenance, updates, and thorough documentation
- Regulatory Compliance: I ensured compliance with 21 CFR Part 11 regulations by implementing electronic signatures
- Resourceful Problem Solving: I conducted extensive research and effectively leveraged available resources to address issues. I actively participated in process improvement initiatives aimed at enhancing efficiency. This allowed me to gain a comprehensive understanding of lead programmer responsibilities and overall departmental processes
- Issue Resolution and Study Documentation: I successfully handled issues related to User Acceptance Testing (UAT) and Production (PROD). Additionally, I have experience in managing study documentation for all study setup projects
Skills
Systems Development Life Cycle
Project Management
Data Management
Good Clinical Practices
Title 21 of the Code of Federal Regulations
Database Design
Architect Modules
Local Labs Central Labs
Randmization
Unit Testing
PDF Annotations
SAS on Demand
Audit Planning
Data Validation
Standard Operating Procedures
Electronic Case Report Forms
WhoDrug and MedDRA Dictionaries
Regulatory Compliance
Electronic Signatures
C# Language JavaScript Vbscript
HTML XHTML XML CSS
NET Framework ASPNET
Problem Solving
Self Motivation
Certification
Certified in Medidata RAVE 5.6.4 Study Builder
Interests
Badminton -Winner of multiple championship cups in Berlin, Germany
Football -Passionate about playing and watching football as an active member of an existing club
Chess -Enthusiastic and passionate about playing chess
Therapeutic Areas
- Oncology
- Dermatology
- Ophthalmology
- Endocrinology
- Cardiovascular
- Hematology
Timeline
Research Development & Sciences
CSL Behring
03.2024 - Current
Principal Clinical Database Programmer
TFS Health Science
09.2022 - 01.2024
Principal Clinical Programmer
CLINIPACE
01.2021 - 08.2021
Principal Clinical Database Programmer
CLINTEC, IQVIA
07.2019 - 01.2021
Senior Clinical Database Programmer
PAREXEL International
10.2014 - 06.2019
Clinical Database Programmer I/II
PAREXEL International
03.2010 - 08.2014