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
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
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
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
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
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
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
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
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