Lee Marshall Email & Phone Number

Holzkirchen, Bavaria, Germany

Munich Area, Germany

Munich Area, Germany

Lead Data Manager

Management of data management employees both as direct reports and in a matrix model for oncology and cardiovascular trialsResponsible for recourse and budget decisions for data managementResponsible for the set-up of the data management groupResponsible for the implementation of standards and training when using an EDC applicationSOP generationImplementation of CDISC/CDASH standards for database development using the PhaseForward InForm application

Select and manage the implementation of EDCAdapt business processes in line with EDC practicesAnticipate resource requirements to meet business needsManage EDC data management teamSOP developmentManage CROs working on Fujisawa GmbH studies

Responsible for designated clinical trials including managing internal data management staff and external CROs working on transplantation and dermatalogical studies. Providing internal and site personnel with appropriate training and documentation to conduct studies to ICH GCP standards including appropriate data cleaning and query generation/resolution processes.

Responsible for data cleaning, query generation and review to ICH GCP and internal SOPs. Additional activities included database testing, coding activities using WHO drug, ATC , MedDRA and COSTART dictionaries and SAE reconciliation.

Responsible for data cleaning, query generation and review to ICH GCP and internal SOPs. Additional activities included double data entry using the Clintrial database.