Sudha Poornima
Bangalore
Summary
Results-driven professional with 20+ years of experience in the CRO industry, with a strong focus on Customer, Delivery, and People Management. A certified Medidata Rave professional with deep expertise in Rave CRF Design, validations, and multiple Rave modules, complemented by Trainer (TTT) certification.
Recognized for successfully managing major pharma clients, leading transitions, and driving process improvements that enable high-performing and innovative teams. Demonstrates strong critical thinking and problem-solving abilities, consistently converting challenges into opportunities. Highly adaptable and experienced in navigating change, with a strong commitment to delivering quality and operational excellence.
Overview
20
20
years of professional experience
Work History
Senior Data Acquisition Expert
Johnson & Johnson Innovative Medicine
Bangalore
06.2023 - Current
- Develop and maintain strong, collaborative relationships with key stakeholders across the organization, including Clinical teams and Global Development functions
- Establish effective partnerships with external collaborators, such as CROs, Functional Service Providers, data vendors, and technology providers, to ensure seamless delivery of data acquisition activities.
- Actively engage with industry groups and forums to contribute to best practices, foster knowledge exchange, and stay aligned with evolving industry standards.
- Execute data acquisition activities across one or more clinical trials of low, moderate, or high complexity, ensuring high-quality and timely delivery.
- Take on a team leadership role across compounds, disease areas, or therapeutic areas, providing oversight, coordination, and guidance to ensure consistent execution.
- Provide input to clinical trial protocols and study planning, review study documentation, and ensure clear understanding of trial-level requirements related to the setup and management of data collection systems.
- Ensure accurate setup and management of trial-level metadata in the metadata repository, in alignment with best practices and defined standards.
- Drive the adoption of clinical data standards to promote consistency across studies, compounds, and therapeutic areas, enabling efficient data transformation and processing into standard models (e.g., DRM/SDTM).
- Oversee the setup, configuration, and management of Electronic Data Capture (EDC) systems (e.g., Medidata Rave) in accordance with established guidelines and best practices, including:Translation of protocol requirements into CRF design and layouts
Development of fit-for-purpose visit schedules aligned with study design
Setup and management of EDC integrations (e.g., CTMS, IWRS, Safety Gateway)
Configuration of tSDV, medical coding, and data mart mappings
Senior Manager, Software Development
IQVIA
Bangalore
06.2019 - 06.2023
- Owned team utilisation for data management programming staff and ensured consistent output.
- Defined resource requirements and coordinated with supervisor to prioritise cross-project assignments.
- Directed work to translate department and office objectives into measurable deliverables.
- Set review standards for data management documentation, database design, and validation.
- Advised internal and external customers, driving faster issue resolution and efficiency.
- Accounted for process and technology rollouts by training staff on procedures.
- Planned professional development needs and mentored staff to grow system capability.
- Chaired customer interactions at project level for data management function outcomes.
- Contributed operational scope input to proposals and supported proposal defence discussions.
- Guided programming requirements and strategic planning during customer meetings.
- Managed scope budgets and assumptions, identifying out-of-scope work for estimation.
- Held teams accountable for data management milestones, maintaining timeline and quality targets.
- Oversaw lead execution of data management programming work supporting production needs.
- Directed staffing actions under policies and regulations, including performance and HR approvals.
Associate Manager/Applications Devl Spec 2
IQVIA
Bangalore
04.2016 - 06.2019
- Deliver high-quality rave events by managing resources and meeting deliverables.
- Improve module collaboration by initiating knowledge-sharing forums across safety gateway, Medidata balance, TSDV, and reports.
- Enable reliable reporting by setting up extraction and data marts, then running rave reports.
Analyst, Clinical Data Programmer
IQVIA
Bangalore
10.2013 - 04.2016
- As a certified SDBE trainer, would train the entire RAVE Team as and when needed. Evaluate the trainees and provide the required feedback.
- Assist in developing, revising, and maintaining core operating procedures and working instructions.
- Conduct Awareness sessions on handling post production changes.
- Manage Rave issue escalations, Liaise between the customers and the team.
- Learn, understand and train the team on Various other modules of the Rave Like the TSDV, Balance, CTMS and the Safety Gateway.
- Be part of the global library Developments for therapeutic area wise.
- Support study Build activities for new FSP, and also develop process around the same.
- Manage Medidata Rave access for the teams for studies and the other Modules.
- Conduct regular Knowledge sharing and Brain storming sessions not only for the team but for the entire FSPs.
Programmer/Analyst
IQVIA
Bangalore
01.2011 - 10.2013
- Plan and coordinate RAVE database design, development, implementation, maintenance, and user support of clinical systems.
- Provide technical expertise in conjunction with internal and external clients.
- Program Rave Front End Checks, test, and document databases in accordance with programming standards and validation procedures.
- Program database manipulation and transfers of data for internal and external clients.
- Make the post production changes in Rave, access the impact of these changes, and run through the migration in the Amendment Manager Module.
- Copy/Delete the subjects using Script utility report before & after the Migration Process.
- Run the proccompare report for premig & Post Migration data and infer the data.
- Investigate & provide solutions for any issues encountered by the team.
- Assist in developing, revising, and maintaining core operating procedures and working instructions.
- Meet objectives as assigned, and interact with the project team to organize timelines, responsibilities and deliverables.
- Develop and maintain good communications and working relationships with teams and external clients.
- Interact with corporate team and CDM team members to negotiate timelines, responsibilities, and deliverables.
- Serve as Lead Programmer on Multiple Projects.
RAVE Programmer II
Omnicare Clinical Research India Pvt Ltd
Bangalore
05.2011 - 01.2013
- Create the specifications for Batchuploads in the BUI interface, Create the test files for each specification created based on the vendor sample files, and load them via FTP to ensure the setup is error-free.
- Identified and resolved issues encountered during the test upload process.
- Ensure client specifications for coded data transfers are met and be responsible for receiving or sending internal and external data.
- Developed and verified procedures for loading client dictionaries to ensure accuracy in data management.
- Develop project specific procedures for loading external data and/or transferring internal data and verify the process. Ensure client specifications for data transfers are met and be responsible for receiving/sending internal and external data.
- Create VSW/BUI/DTP documents based on templates and ensure that standard process is followed during creation and updating.
- Review of client specification documents with team for discussion, finalization and signature.
- Batch loading data into client's database(s), reviewing output and assisting client teams on error resolution.
- Assisted client teams during snapshot, lock, and data review phases to facilitate timely project milestones.
- Build SAS Edit checks for external lab data.
- Guided new team members and assigned specific responsibilities to improve team efficiency and knowledge transfer.
- Interact with Biometrics and other departments concerning database contents and structure as necessary.
- Provided programming support and assisted CDM managers in daily technical operations.
eCDM Developer/Technical Designer
Accenture Services Pvt Ltd
Bangalore
09.2006 - 05.2009
- Have worked on the User Administration and Site Administration Module to Create Sites, Assign Sites and user roles to the studies in the auxiliary environment.
- Develop the eCRFs, from basics, from creating the Draft, Folders, Forms, Matrices, Unit dictionaries and Data dictionaries, and mapping them as per the Protocol Requirement.
- Configure validations (Derivations, Special actions, Dynamic forms, Dynamic fields, system edit checks/ Field edit checks, Configured Edit checks) required for the EDC study as specified in the study protocol.
- Write validation from the protocol or as per the DVS.
- Update the specific 'Study issue sheet' with required Changes and suggestions if any.
- Unit tested configuration and setup of eCDM systems and completed peer review.
- Created and updated core configurations for specific studies to ensure alignment with project requirements.
- Verification of the validations implemented in the EDC study.
- QC the Configuration units, document and final submission.
- Train new hires to configure and build systems using Medidata RAVE tool.
Education
Master of Science - Biochemistry
The Oxford College of Science
Bangalore, India05-2009
Bachelors of Science - BioTechnology
The Oxford College of Science
Bangalore, India01-2006
Skills
- Rave
- SDTM
- Project Management
- People Management
- Data acquisition
- Electronic data capture
- Data standardization
- Stakeholder engagement
Custom
Available on request.
Timeline
Senior Data Acquisition Expert
Johnson & Johnson Innovative Medicine
06.2023 - Current
Senior Manager, Software Development
IQVIA
06.2019 - 06.2023
Associate Manager/Applications Devl Spec 2
IQVIA
04.2016 - 06.2019
Analyst, Clinical Data Programmer
IQVIA
10.2013 - 04.2016
RAVE Programmer II
Omnicare Clinical Research India Pvt Ltd
05.2011 - 01.2013
Programmer/Analyst
IQVIA
01.2011 - 10.2013
eCDM Developer/Technical Designer
Accenture Services Pvt Ltd
09.2006 - 05.2009
Master of Science - Biochemistry
The Oxford College of Science
Bachelors of Science - BioTechnology
The Oxford College of Science