Heike Ammermann

- Collaboration on creation the eCDP Admin guide, maintenance and review. Conduct research and analysis into the content, relationship and value of eCDP data tables - Function of Subject Matter Expert for eCDP Dashboard issues. Communicate information and know-how to end user - Consults with functional areas to develop understanding of the varied and complex business needs supported by Cognos reports and replacement by AIX and/or eCDP Dashbard"

- Global First level support of CSMS users - Communicate between Central CSMS IT Support and end users, provide information and know-how - Subject Matter Expert (SME) for Dataloader, SharePoint, IMPACT Subject Visit Design, IMPACT in General, Account Management (AM) using different methods for several systems - Support delivery and implementation of AM tool, leading those enhancement and implementation of replacement - SME for system training (assignment /verification) in company related training tools

- First level support to Clinical personnel users on use of the tool - IMPACT: Set up, creating and maintaning CDPs, Studies, Site personnel (investigator and site stuff) and linking with their facility address, Clinical personnel and assignment to their sites - Direct liaison between Clinical Personnel, the Research Information Center (RIC) and the Support team - Provide clinical study metrics to Clinical team and Clinical Management, provide updates to Finance on regular basis

- Set up of Clinical Database in PCDM (Oracle based) and Flex DMS (known as DataLabsXC based on Microsoft Server) - Set up loading process of external data - Programming and Testing of Consistency checks in PL/SQL and VB Script - Programming of data listings for medical monitoring in SAS - Dataimport external data - Dataexport to Client - Programming of database converions and creation of SAS datasets according to Client Data Specifications

- Creation of Data Validationplans - Programming and Testing of Consistency Checks - SAS Data Step Programming - Descriptive Analysis with SAS

- Query Management (Evaluation, processing and resolving the data discrepancies, creation of Data Clarification Forms) - Creation of Dummy data based on Data Validation Plan - Testing of Consistency Checks based on Data Validation Plan using the Dummy Data - Contact Person for Laboratory values - Collection of sites and investigators in Study Database - Coding of AE and Concomitant Medication using MedDRA and WHO - Validation of SAS codes