Clinical Database Programmer

Hema Mani

********.*@*****.*** +* – 306-***-****

https://www.linkedin.com/in/hemapa Saskatoon, SK, Canada (CST)

Canadian Permanent Resident

Professional Summary

20+ years of experience leading clinical data systems, EDC implementation, Safety integrations, and cross-functional clinical technology solutions initiatives supporting global Phase I-IV clinical trials.

Accomplished Clinical Systems Expert and Safety Integration Specialist in Medidata Rave EDC, Medidata Rave Safety Gateway and TSDV, with deep expertise in managing the end-to-end data flow between EDC and Safety Database (Argus).

Proficient in E2B(R3) data mapping, regulatory compliance (GVP, 21 CFR Part 11), and high-integrity system migrations.

Strong expertise in the entire phase of clinical trials that includes Analyzing, Designing, Development, Testing, Implementation, Maintenance, Production Support, Migration of clinical database.

Managed 7+ concurrent clinical data system projects, delivering study builds, integrations, and compliance solutions with timelines and budget.

Expert in bridging the gap between clinical efficacy data and GVP-compliant safety reporting through Risk-Based Monitoring (RBM) strategies.

Experience in handling Projects and Internal Teams and Vendor Management Skills to ensure their data integrates seamlessly into EDC.

Hands-on experience in developing Edit Checks, Custom Functions, Custom Data Extracts, Custom Integrations and Custom Reporting development on Medidata RAVE EDC systems.

Expertise in Amendment Manager – study migrations.

Specialist in CDMS like Medidata RAVE, Medrio, Merge eClinical OS, Inform and Veeva CDMS EDC.

Domain Expertise in Pharmaceutical, Health Care, Clinical Data Management.

Good Knowledge of ICH GCP, GVP, 21 CFR Part 11, SDTM, CDISC, CDASH.

Excellent Team leading, presentation and interpersonal skills with a strong desire to achieve specified goals.

Dynamic team player with ability to work with all levels in an organization.

Mentored and trained cross-functional teams and study builders improving project delivery consistency.

Therapeutic Experience:

Phase I/II/III/IV – HCV, HBV, LD, HIV, Oncology, Rheumatology, RESP, CVS

Educational Qualification

Master of Computer Applications (M.C.A)

Bachelor of Sciences (Chemistry)

Trainings and Certifications

Medidata Solutions RAVE Certified Study Builder from Medidata Solutions – July 2018.

Medidata Solutions RAVE Certified Study Administrator from Medidata Solutions – Sep 2018.

Lean Six Sigma White Belt – Jul 2018

Hands-on Training in Veeva CDMS EDC and Medrio CDMS EDC for eCRF design, study build, and data collection workflows.

Core Competencies: Clinical Data Management, Clinical Trial Management, Vendor Management, Risk Based Monitoring, Regulatory Compliance, Safety Integrations, Clinical System Validation, Clinical Project Management

Technical Skills

EDC and CDMS Architecture

Medidata RAVE, TSDV, CTMS, RTSM, Veeva CDMS, Medrio, Merge eClinical OS, Inform

Safety Integration

Rave Safety Gateway (SME), E2B(R3) Data Mapping, SAE Reconciliation Logic

Programming and Reporting Tools

C# .Net, SQL Server, My SQL, MS Access, Oracle, SQL Server Reporting Services, Crystal Reports, Business Objects XI, JReview

Regulatory Compliance

ICH GCP, 21 CFR Part 11, CDISC SDTM/CDASH, GVP

Process Improvement

Lean Six Sigma White Belt, Agile Project Management, Vendor Management.

Medical Coding

MedDRA, WHODrug (Synchronization & Up-versioning)

Professional Experience

Syneos Health, Canada Feb 2023 to Apr 2026

Clinical Systems Specialist/ Programmer

As a subject matter expert – providing technical EDC support to internal study teams on all programming related activities.

Served as the lead architect for Rave Safety Gateway implementations, ensuring the seamless, real-time transmission of SAEs to Argus for global Phase I-IV trials, ensuring 100% accuracy in the automated transmission of Serious Adverse Events (SAEs) to safety systems.

Risk-Based Monitoring - Configured and validated the Medidata Targeted Source Data Verification (TSDV) module to execute complex Block-Plan and Subject-Plan verification strategies, ensuring 100% oversight of critical safety variables while reducing overall monitoring burden and to prioritize the verification of Serious Adverse Event (SAE) data and primary endpoints, ensuring maximum data integrity for regulatory safety submissions.

Acted as the primary technical point of contact for internal safety teams, external vendors and Sponsors ensuring all integrations met E2B(R3) and 21 CFR Part 11 requirements.

Proactively monitoring internally and externally hosted applications for performance and system errors

Directed large-scale study migrations using Amendment Manager, maintaining 100% data integrity and system uptime during critical mid-study transitions.

Manage external application, vendor issues, integrations and implementations.

Led and mentored a global team of database programmers, establishing standardized SOPs for system builds and UAT processes.

Syneos Health, Amsterdam, The Netherlands Dec 2021 to Jan 2023

Principal Clinical Programmer

Manage and support all functional tasks and project deliverables for multiple studies.

Responsible for design, development, testing, maintenance and migration of clinical databases for assigned studies.

As a subject matter expert – providing technical EDC support to internal study teams on all programming related activities.

Proactively monitoring internally and externally hosted applications for performance and system errors

Manage external application vendor issues, integrations and implementations.

Mentoring and leading the new team members

Bolders Consulting Group, Amsterdam, The Netherlands Nov 2020 to Nov 2021

Client: AstraZeneca, Sweden (Worked remotely from Netherlands)

Sr. EDC Specialist/Programmer

Lead the Core configuration review and update with the Data Managers and the internal team members.

Support Rave security and user account management in iMedidata across multiple URLs.

As a subject matter expert – providing technical EDC support to internal study teams on all programming related activities.

Implemented Targeted Source Data Verification (TSDV), configured block-plan and subject-plan strategies to prioritize verification of critical safety variables and primary endpoints.

Lead the system integration with Rave and VCV Implementation with external vendors

Provide support for study start up, conduct and close out studies

Custom report programming in BOXI

Create and update SOPs, WI and guideline documents for EDC

Responsible for issue investigation in production database.

Responsible for the training, mentoring, and growth of new team members.

Involved in process improvements and best practices implementation.

Solverminds Solutions and Technologies (SVM Pharma, UK) Sep 2020 to Nov 2020

EDC Project Manager

Leading the Development team, Coordinating and Communicating the requirements for the tool.

Helping the team on the development of internal EDC Tool for Clinical Studies.

Handling and working on Oncology trials and building the clinical database as per the specification.

Mentoring and guiding the team on the clinical domain.

Involved in process improvements, Creating SOPs and best practices implementation.

Gilead Sciences, Foster City, CA, USA Jan 2016 to Apr 2020

Sr. EDC Programmer

Managing all the new study builds across all therapeutic areas and resource allocation both internal and external vendors.

Worked in the Project Management capacity to lead both internal and vendor study team meetings for review and status updates throughout study build process and interact with vendors to communicate expectations for study timelines and milestones are met and deliverables are of high quality.

Strong leadership skills and the ability to work and communicate effectively across multiple teams and cross departmental teams.

Develop and maintain a close liaison with Data Managers / Bio-Statistician, Program Managers, core team members to ensure the timelines are met for successful project delivery.

Lead client study team meetings for review and status updates through study startup and Post Go-Live support.

Strong time management skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines, capable of negotiating schedule changes per the project timelines.

Proactively identify potential risk and provide risk mitigation strategies during the study build process.

As a subject matter expert – providing technical EDC support to internal study teams on all programming related activities.

Involved in iMedidata roll out strategy and planning.

Lead the Core configuration review and update project with the internal team members.

Worked on multiple studies to update the database based on GDPR update processes.

Worked on Global library implementation and Rave Safety Gateway processes.

Responsible for issue investigation in production database.

Strong attention to detail and capable of identifying and providing effective resolution for technical problems.

Responsible for the training, mentoring, and growth of new team members.

Involved in process improvements and best practices implementation.

Wincere Inc., Santa Clara, CA, USA Aug 2011 to Jan 2016

Programmer Analyst

Worked with multiple Clients - Gilead Sciences, Onyx Pharmaceuticals, Edward Lifesciences, Bayer, Biomarin.

Develop and maintain a close liaison with Client/Sponsor, core team members, Project Managers, Data Manager / Bio-Statistician to ensure the timelines are met for successful project delivery.

Lead both internal and client-facing study team meetings for review and status updates through study startup and Post Go-Live.

Manage project and the resources necessary for their successful execution.

Worked on Phase I/II/III/IV - Oncology, HIV, RESP, HCV/HBV, CVS Clinical Trials.

Therapeutic Area Lead for all Liver Disease (HCV, HBV, Liver Fibrosis) studies at Gilead Sciences.

Reviewed study-specific protocols and design Case Report Forms (eCRFs) for potential data collection.

Prepared annotated eCRFs and unique eCRFs

Responsible for creating eCRF specifications and Data Validation specifications through the life cycle of a trial.

Programmed Edit Checks and Custom Functions in Medidata Rave.

Extracted Clinical data from RAVE EDC System for the SAS Custom Data Extract process.

Responsible for design, development, testing, maintenance and migration of clinical databases for assigned studies.

Responsible for the training, mentoring, and growth of new team members.

Involved in process improvements and best practices implementation.

Transnative Associates Inc, Santa Clara, CA, USA Jun 2009 – Aug 2011

Programmer Analyst

Worked closely with the client in understanding their data processing and business requirements in providing highly available technical solutions.

Involved in the development of Star and Snowflake to model the data warehouse.

Designed database, database objects and SPE data warehouse effectively considering the facts and dimensions.

Scheduled Jobs in SQL server agent to automate the SSIS packages executions.

Wrote complex T-SQL queries and Stored Procedures to transform the data and load to the Fact tables.

Implemented Slowly Changing Dimensions (SCD) to maintain historical data in various data marts.

Created Cross-Tab, Drill-down, Sub-Report, Customized and Ad-hoc reports using SSRS.

Identified and worked with Parameters and fetched data using complex MDX expressions for generating parameterized OLAP reports in SSRS.

Prithvi Information Solutions Ltd, India Oct 2007 – Dec 2008

Sr. Software Engineer

Involved in high level design document by interacting with the client for the understanding of the raw business requirements and translating them for designing technical requirements.

Experience in using dynamic management views (DMV) and dynamic management functions (DMF) for finding out long running queries.

Created Re-Usable Components – Data Export Utility SQL script which extracts the data from the database and generate the required file format, the extracted files then transferred to the FTP Server.

Migration of the database objects from MySQL and Oracle DB to SQL Server 2005 using SSMA (Migration Assistant).

Configured and maintained Report Manager and Report Server SSRS.

Coding Stored Procedures, Views, Indexes and Functions and implementing the business logic.

Generated alerts using the Notification Services 2005 by sending emails.

Ecentric Solutions Pvt Ltd (Paradigm Infotech), India

Sr. Software Engineer - Medidata Rave May 2005 – Sep 2007

Performed various activities for Medidata Solutions as a partner to eCentric solutions for study build, edit check implementation and custom function programming and testing.

Worked on complex edit checks and custom functions.

Implementing the custom functions business logic through Stored Procedures and T-SQL Queries in SQL Server and mapping the business logic code to the web application.

Fixing the Production Issues relating to the database queries and performance

Coding Stored Procedures, Views, Indexes and Queries.

Trouble shooting and query optimization.

Performed Unit testing of the Rave after implementing the logic.

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