Jovanni Gonzalez

Facilitated clinical database development to properly execute collection, receipt, reporting, review and archiving of quality clinical trial data. Included eCRF planning discussions, coordination of eCRF review, planning and identification of system and protocol specific edit checks, coordination and proper execution of user acceptance testing, and coordination, planning and development for external data sources, as needed. Interacted with internal and external project team members (including external data vendors) for multiple projects, as appropriate. Actively contributed to study team discussions, standing meeting agendas, meeting attendance and review and/or documentation of minutes. Communicated with assigned data team members to ensure tasks are coordinated and executed as per study plans and timelines as appropriate. Ensured training of study-specific protocol requirements as appropriate. Identified and communicated gaps in training and supports training of data reviewers. Oversaw of study budget applicable to functional area. Ability to identify and communicate potential out of scope activities to project team. Worked with study team to provide the necessary information for re-scoping when applicable. Contributed and presented in Bid Defense meetings.

Oversaw the delivery of all relevant data operations activities from database setup through database lock, data transfers and external data reconciliation. Provided technical guidance for development, design, and systems integration. Served as Team Leader. Review team member activities and deliverables to ensure plans and processes are followed. Managed Change in Scope, Budget, and Revenue Recognition. Review project budgets and staffing projections for DM activities. Trained and Mentor Data Management Staff. Functioned as main point of contact for Internal and External Clients. Communicated project progress to the Sponsor and Project Team by providing monthly metrics and participated in cross functional meetings. Discussed Data Management roadblocks and solutions with Project Manager and Data Operations. Coordinated Project Setup, Develop and/or review Data Management Documentation. Managed appropriate project level resourcing of staff and staff assignments. Identified and requested staff necessary for the project team. Participated in cross functional meetings and drive initiatives, participate in Business Development and BID Defense meetings as required.

Took overall accountability for the execution of the Data Management strategy from database setup through database lock and the Data Management technology set-up for the project. Provided leadership and expertise in all aspects of Data Management and Clinical Data and Database Programming. Managed the delivery of all relevant data operations activities from database setup through database lock and data transfers. Coordinated relevant Data Operations team members and their activities across all geographies, liaising with project leadership, other functional leaders (clinical, biostatistics, medical, medical writing etc.) and the client as a single point of contact to ensure that the contracted data deliverables were being met – specifically in terms of timeliness, financial management and quality. Participated in meetings with Business Development / Portfolio Directors / Project Leadership to understand the scope of the contract and any Master Service Agreement in place for the client. Effectively communicated to and managed internal project teams, external customers, and third-party vendors. Held team meetings on a regular basis. Participated in client, investigator, and team meetings.

Responsible for project data management activities pertaining to clinical trials, including but not limited to: the design, development and validation of tools and ongoing data review. Also, contributed to to the preparation of all data management study documentation and processes. In addition, served as a mentor for other Data Managers. Responsibilities also included interaction and coordination with staff across multiple sites.