Ernestine Mitchell Email & Phone Number

Durham, North Carolina

Business Systems Support – functional service provider partner to GSK business systems owners to influence and support development, maintenance, enhancement, and embedding of clinical recruitment planning and site-selection systems and processes; expert user and subject matter expert providing ongoing user support and training.

Durham, Nc

Systems Support - influenced and supported development, maintenance, enhancement, and embedding of clinical recruitment planning, site-selection, and business intelligence systems; served as an expert user and subject matter expert to provide ongoing user support.Communications and change management – engaged vendors and stakeholders, led development and delivery of technical and business process training presentations, gathered and evaluated business requirements, and planned and tracked benefit realization of clinical systems.Business Strategy - liaised with business system owners, business leads and information technology leads to develop strategic planning for continuous improvement of clinical systems.Governance – provided ongoing evaluation of the validity and appropriateness of clinical study metrics, dashboards, and reports.

Durham, Nc

Performance metrics consultancy - evaluated and defined business requirements for key performance indicators of clinical processes and performance metrics delivery platforms; defined and applied appropriate analyses to facilitate business decision-making and strategy formulation.Performance metrics delivery - identified, developed and ensured the delivery of global clinical performance measures via business intelligence and reporting tools.Training - promoted the use business intelligence and recruitment planning tools by developing eLearning modules and job aids, and conducting demonstrations and training/awareness sessions.

Durham, Nc

Programming - developed and executed programs to produce listings and tables, perform data consistency checks and statistical analysis, and create data entry screens for Phase I studies.Process Improvement - developed data flow diagram of the operations, interrelationships, and handoffs within and between Clinical Pharmacology/Clinical Pharmacology Data Sciences to uncover inefficiencies in the process and make suggestions for process improvement; collaborated with a team of contributors to write/revise data management international working practices.Training - delivered working practice training and awareness sessions; mentored data managers/database programmers/analysts; supported lead users of clinical planning and management applications; developed training curriculum; liaised with IT support to resolve user’s issues.

Durham, Nc

Programming - set up databases for loading clinical trial data for Phase I-IV studies; developed and executed programs to perform data consistency checks and create data entry screens.Training - conducted training courses on protocol setup and writing consistency checks; mentored data managers/database programmers/analysts.

Durham, Nc

Data management - reviewed case report forms and validation reports to monitor data quality, queried investigator sites; designed and documented database structures; loaded data files into databases. Training - developed training manual for an online editor and an in-house clinical database module; conducted; conducted training/awareness sessions; mentored data managers.

Durham, Nc

Data management - reviewed case report forms and validation reports to monitor data quality, queried investigator sites; edited data on-line and with utility programs; led an adverse event cleanup team for an NDA submission.Training - supervised and trained temporary employees to process data on-line.

Durham, Nc

Study conduct - designed and administered statistical analyses; performed statistical analyses; wrote sections of research grant proposals and research reports; designed and conducted a pilot study of self disclosure in preschool aged children.Office management - assessed supply and budget needs of a psychology research laboratory; maintained library of literature searches.

Durham, Nc

Study conduct – screened/enrolled patients; dispensed study medication; measured vital signs; collected/prepared sputum, fecal, and blood specimens for shipping to central laboratory; completed case report forms/progress reports; monitored patient progress through chart review, daily visits, and interviews.Training - instructed attending physicians and nursing staff in protocol requirements.

Strategic Intervention Life Coach

Strategic intervention life coaching

Bachelor Of Science (B.S.), Psychology

Activities and Societies: Modern Black Mass Choir (president)