Nimish Patel Email & Phone Number

San Mateo, Ca, Us

Foster City, Ca, Us

South San Francisco, California, Us

In addition to duties in our group as an Ops Manager, I served as an Individual Contributor to a variety of projects where I represented the needs of our division of Research and Early development as it pertained to our enterprise wide initiatives. My main project is to drive the integration solution of 6 CRO partners to our Veeva CTMS, which required co-develoment and testing strategies for go live end of 2024. I was the main point of contact for all system risk analysis tasks with Digital Technology Organization for innovative digital health tools and research. In order to work with new vendors that our clinical scientists and DTO group wanted to collaborate with, I helped conduct vendor and system risk assessments with our global IT team as per Roche SOPs. Using ServiceNow, we performed all duties from change management of software to user requests to our department.I was the liaison between clinical data management and quality team on the scaling of RBQM initiatives by evaluating the streamlining of data sources.As a core team member on ECD Allyship team, I promoted learning journeys for underrepresented communities and facilitated discussions ranged from D+I, current events, and intersectionality. We fostered inclusiveness and discussions around allyship.

South San Francisco, California, Us

Tasked to roll out the implementation of new Safety Document Distribution for our early development department, as it pertained to duties performed by Clin Ops, Operational Change Management, and CROs (6+). Worked with Protocol Execution Team members including Clinical Operations, Biostatistics, Clinical Supplies, Data Management, and Vendor PMs, to deliver high quality and efficiently designed systems and dashboards. Identify process inefficiencies and compliance gaps and participates in process improvement initiatives for digital health solutions (internal and external).

Pleasanton, Ca, Us

As a product manager, I was primarily responsible for developing Product Requirements for features in Vault CDMS for both EDC (Studio) and CDB: Veeva's solution for Data Managers to help review, clean, and track their work performed on all of their study's Clinical Trial data. For CDB, my main focus was on how to seamlessly integrate data collected both within and outside of Veeva CDMS. I helped designed large batch data integrations for file drop as well as future API development. Worked closely with 2 large enterprise sponsors to perform proof of concepts of migrating use of their CDMS tools into Veeva's product. Data sets that I had to interact with included FHIR, STDM, ADaM, Labs, eCOA, EDC, and IRT. When I first joined, I leveraged my customer service experience by serving the role as Product Liaison between CDMS Services team, customers, and Product: I was tasked to gather product feedback, 2nd tier support for Services and Customers for product related issues.

Worked closely with customers to analyze clinical data (EDC, CTMS, IRT, ePRO, Safety) for driving analytics and visualizations. Built custom KPIs based on customer requirements for measuring health of clinical trial. Supported sales team on implementation recommendations and demonstrations of KPI capabilities to prospective customers.

San Francisco, Ca, Us

Developed Product Requirement Documents for development of features in application.Created UX/UI wireframe for developers to implement during development of new features.Wrote detailed Product Requirements for two Android applications and managed project from design to launch using Agile/SCRUM.Triaged Bugs filed by Test team by providing stack rankings for prioritization.Conducted training to customers and new employees on eClinical software.Developed training guides and best practice documentation for EDC software. Successfully managed the transfer of 2yrs worth of study clinical data from different study for large Medical Product company to continue data collection for 5+ years using ETL/ODM/XML tools ("Rescue Study").

San Francisco, Ca, Us

Provide services for customers looking for additional help in:-Software Training-EDC builds-Study Implementation-ETL/Data IntegrationConducted 50+ training sessions to customers and new employees on eClinical software functionality. Trainings performed via Instructor Led Workshops onsite, WebEx, and Webinars customized to client’s protocol. Organized and initiated customer webinars to introduce new feature and answer customer questions in virtual setting. On average 30 customers attended each webinar. Collaborated with Technical Writer on staff to develop training videos. Topics taken from top frequently asked questions coming from customers to Support team to reduce number of cases. Narrated and produced training videos customized to different users and customers.

Durham, North Carolina, Us

Work directly with client IT departments to collaborate on installation and deployment procedures. Interpret client needs, suggest effective solutions and work with clients on identifying deployment options. Provide positive on-site client installation of TrialWorks products including interfacing with client personnel and maintaining project-specific documentation. Proactively provide day-to-day oversight of training projects. Execution of these projects includes, but is not limited to: interfacing with client personnel, maintaining project-specific documentation, and providing onsite or remote training. Develop standard training materials including manuals, quick start guides, technical user guides, and the like, in both online and offline formats. Develop and maintain technical materials including installation and upgrade procedures, manuals, handbooks and the like, in both online and offline formats. Liaise with engineering department regarding the same. Query data sets provided by clients to find discrepancies and provide solutions on how to correct.

South San Francisco, California, Us

Responsible for performing system administration duties for TrialWorks (CTMS) to configure application for company needs. Developed and deployed Pareto charts and line listing reports for Senior Management to analyze system usage by users and ticket submission/resolution metrics by building MS Access databases using ODBC connections. Provided ongoing second and third level support and administration of the production applications in web based and MS SQL database environments. Actively participated in interface with vendor support, DBA and internal application support team to resolve system issues. Conducted onsite and WebEx-based user trainings on database structure and troubleshooting tips.

Emeryville, California, Us

Assigned as System Administrator of drug safety information and reporting systems. Provided impact analysis and solutions to complex user issues for ongoing validation of systems. Executed test scripts, Installation and Verification Qualifications for drug safety information and reporting system upgrades. Developed Adverse Events queries for periodic and ad hoc data requests for regulatory authorities to support clinical trials and safety profiles of marketed products. Performed technical reviews of data listings that support clinical trials and safety profiles of marketed products. Provided ongoing user support for Medical Physicians, Drug Safety Specialists and Coordinators

Durham, North Carolina, Us

Responsible for developing requirements and programmed study specific project reports. Provided ad hoc query support for Site, Project, and Data Management Teams. Developed, maintained and deployed training programs and presentations to user groups and potential clients. Acted as first level support between database group and users of Clinical Trial Management System. Designed and conducted data imports and exports with clinical data systems for purposes of generating reimbursement for physicians and client reports by building DTS packages on SQL Server and FTP transfers on SSL network.Started as Research Coordinator (2001-2003). Served as lead for clinical operations on Phase IV and Registry studies in accordance to GCP guidelines. Responsible for supporting interested investigators through the contracting and IRB approval process to facilitate participation in research studies. Effectively acted as point person to field CRA’s while conducting on site monitoring visits.

Masters Information Systems Management, It

Ba, Mcb - Immunology