Bobby O. Email and Phone Number

•Manage Study Start-Up: work across several studies to ensure all required documentation is in place to authorize sites for study enrollment; Manage and participate in UAT of eCRF build and validation documents.•Develops/executes/reviews project documentation including but not limited to, data management plan, eCRF Completion Guidelines, Edit Check, Query Logic, UAT, and work instructions for assigned projects.•Manage CDM activities including Medical Coding, Data Validation Checks, and Database Snapshot; Lead one or more studies at a client.•Collaborate with cross-functional team members and study sites throughout all studies.•Manage communication with eCRF/database vendors on consistent basis to address clinical team requests and/ or eCRF development activities.•Ensure the quality of clinical data to support study report, IND and NDA submissions meets standards.•Provide Clinical Data Management support to cross-functional team and participate in the review of Clinical Rese arch Documents (Protocol and CRS) as needed.

• Coordinates and participates in the development of the clinical data model and/or database design eCRF according to specifications• Participates with the study operation teams for all study activities and lead all DM functional activities using established templates/processes as applicable.• Assists in identifying and implementing solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts.• Oversee/manage DM related activities for in-house databases and those activities outsourced to DM Vendors as well as other external data sources from study start-up to study close-out.• Manage final database lock/transfer activities while ensuring that all study deliverables and milestones are met on time and within budget.• Draft data review guidelines / diagnostic specifications consistent with the clinical data model, and CRF (eCRF) completion/monitoring.• Develop and test data management system edit/data validation checks (diagnostics) and custom listings/procedures used as tools for the data review and discrepancy management activities.• Collaborate on all required database validation protocols and reports.• Develope all required data management plans including but not limited to Data Management Plan, Data Quality Plan, UAT Plans, eCRF Completion Guidelines and Data Review Guidelines.• Regularly reviews and queries clinical trial data as indicated in the Data Review Guidelines, Data Validation Specifications and Data Management Plan.• Review study data for completeness and clinical sense. Assess the overall quality of data and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns, e.g., increased frequency of queries, protocol deviations, and early treatment discontinuations.• Serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities.

• Operated as lead CDM on assigned clinical trials by attending internal and external clinical trial project team meetings. • Ensure project documentation is being archived in a timely manner into the Trial Master File• Participated in development of Standard Operating Procedures (SOPs).• Responsible for the study-specific data management tasks from protocol review to database lock to ensure data are collected, reviewed, and delivered with high quality, on-time, and within Product. • Responsible for the accurate development of CRFs and edit specification per protocol and the completeness of user acceptance testing of CRFs and associated edit specifications for assigned clinical trials.• Mentor junior staff on clinical data management activities and procedures. • Provide guidance to clinical data management personnel on assigned projects, reviewing study documents as needed, e.g. Data Management Plan, Operational Plan for database locks• Provide ongoing operational support for Medidata RAVE activities during clinical trial conduct including development of clinical databases and associated external data transfer documents including import/export agreements and data specifications.

• Worked with project management to define timelines for assigned studies to ensure critical data management milestones are met• Managed data management resourcing for assigned studies• Performed monthly revenue recognition for data management activities• Represented data management on study team and client meetings, regularly informs project management and client of overall study status, provides risk assessment, and potential problems and out of scope• Lead a multi-functional project team of biometrics resources including database programmers, clinical data coordinators, and SAS programmers.• Participated in the development and maintenance of SOPs and working practices related to data management activities• Performed query management activities and external vendor reconciliation• Supported with other data management duties as assigned• Worked in partnership with cross-functional teams to ensure effective solutions and to provide quality support to study teams

•Assisted with data reconciliation • Supported CRF development, database development, and testing on new studies • Supported maintenance, distribution and tracking of study status reports to clinical study teams, project teams, investigational sites and other stakeholders • Maintained documentation of all clinical research activities• Follows established SOPs and work instructions• Maintained device administration & documentation • Point of contact for Clinical Research Associates for data related inquiries and data reporting. • Manage delivery of projects through full data management study lifecycle (with minimal guidance)• Working knowledge of ICH/GCP guidelines and FDA regulations