Steven Mcrae Email & Phone Number

United States

United States

Fishers, Indiana, Us

• Elicited requirements and developed user stories for Veeva Quality Docs and Veeva QMS Vaults• Developed test plans and User Acceptance Testing to validate requirements• Lead migration and integration activities between legacy systems and Veeva modules utilizing Mulesoft• Performed IQ/OQ/PQ validation• Configured workflows, and managed security and groups in Veeva Quality and Regulatory applications• Defined, developed, and implemented data analytics and visualization solutions utilizing PowerBI and Tableau• Utilized Agile development to meet timelines and deliverables

Thousand Oaks, Ca, Us

• Project level coordination of, and day to day oversight of data management tasks including; coordinating with lead data managers and managing vendor deliverables, and confirming that system quality control checks were being implemented• Reviewed project timelines and metrics to ensure databases were delivered within set timelines• Lead electronic submission activities• Lead the development, review, and implementation of processes, policies, SOPs, and associated documents affecting data management, including cross functional working groups• Worked closely with Clinical System Managers to ensure proper integration and data transfer among Electronic Data Capture (Medidata Rave), Interactive Response Technology (Endpoint Clinical), and Clinical Trial Management (Veeva Vault CTMS) systems utilizing SAS• Developed and coordinated project level training for data management staff• Contributed to the development of data management outsourcing strategies and long-term relationships with CRO partners and external vendors

Sunnyvale, Ca, Us

• Responsible for all activities of clinical trial data management including CRF design, database and edit check development, query generation/processing, reconciliation of CRF and electronic data, and database cleaning activities• Planning and implementation of the data management portions of clinical research projects. Developing CTMS systems for organizing data to analyze, identify, and report trends• Working with CRAs and statistical functional areas to provide accurate data acquisition and to furnish accurate and well-documented study databases to the statistical and clinical teams• Responsible for timely identification of protocol deviations and process improvement

North Chicago, Illinois, Us

• Worked with stakeholders to define business requirements for EDC, CTMS, and eTMF applications• System Administrator for Veeva EDC, CTMS, and Trial Master File vaults• Developed reports, dashboards, and metrics to ensure real time inspection readiness • Subject Matter Expert in utilizing electronic Trial Master Files for audit and inspection readiness activities• Proactively identified areas for process improvement• Liaison to all functional areas utilizing Veeva and Salesforce applications• Developed work instructions and SOPs for electronic systems• Trained new personnel in EDC, CTMS, and eTMF business process

North Chicago, Illinois, Us

• Supporting the development of the clinical study protocol and associated systems and documents (Informed Consent forms, eCRFs, IRT, CSR)• Supporting vendor selection, scope development, management and oversight of external vendors• Responsible for generating the study related training for the study team, study sites, and vendors for assigned studies• Preparing Clinical Study Team meeting agenda and minutes• Responsible for regular updates to the cross-functional team and stakeholders on study status; ensuring Clinical Trial Management System and Trial Master File is up to date

Master Of Science In Pharmacy (Ms), Pharmaceutical Chemistry

Bachelor Of Science (Bs), Chemistry And Microbiology