Tabitha Botz Email & Phone Number

Lincoln, Ne, Us

Lincoln, Ne, Us

Princeton, New Jersey, Us

Princeton, New Jersey, Us

Durham, North Carolina, Us

Perform and manage all aspects of data management from study set-up to database lock. Collaborate with sponsor team to develop effective project plans including scope, goals, deliverables, required resources, risks, and milestone timing. Develop and maintain project specific database including CRF design, edit checks, and user acceptance testing. Oversee all teams involved in data review, approve quality checks and exception reports, and provide CDM expertise. Track and ensure all timelines and deliverables are met by all data teams. Plan and execute multiple DM projects for a program of studies. Participate in business development presentations and sponsor/regulatory audits. Effectively manage financial budget and any change in scope.

Lincoln, Ne, Us

Directly managed team which included Data Managers, Quality Control Specialist and Data Entry staff. Mentored and helped other DM Managers. Oversee project management, customer relations, and quality metrics for DM teams. Act as DM subject matter expert and gatekeeper for leading strategic partner including the creation and maintenance of all sponsor specific templates and guidance tools, review of all critical DM documents prior to posting to sponsor, and lead all communication with sponsor related to DM activities and process updates.

Lincoln, Ne, Us

Hire, train, and develop a team of Data Managers, Quality Control Specialist, and Data Entry staff. Responsible for timely completion of project milestones, quality metrics, and successful customer relations. Participate and present at bid defense meetings, site qualification, study initiation, quality and FDA visits. Write and review global SOPs and procedure guides.

Lincoln, Ne, Us

Held full responsibility for the coordination and implementation of all clinical training including new hires, technical and regulatory, certification maintenance, and soft skill training for 200+ associates. Decreased new hire training timeline from 10 weeks to 5 weeks. Develop and coordinate study specific training in order to meet protocol requirements.