andrea seyberth

* Managing and coordinating all Data Management related tasks and activities for all Phase I trials internally and with various external service providers * Implementing an EDC system solution for Actelion Phase I * Setting up and conducting the first EDC trials within Actelion * Evaluating and configuring the EDC system ‘MARVIN’ for Actelion Phase I by conducting two pilot trials completely in-house * Establishing the Phase I data collection and storage standard based on the CDISC ODM, CDASH, and SDTM requirements * Creating SOPs for all Data Management related processes, tasks and responsibilities in Phase I and compiling corresponding templates and working instructions for all Data Management related documents * Supporting Phase II and III EDC implementation and data standardization project initiatives by participating corresponding working groups * Managing, introducing and supervising Clinical Pharmacology Data Managers.

* Managing and coordinating all Data Management related tasks and activities for all Phase I trials internally and with various external service providers * Review and approval of all Data Management related documents (CRF, Data Management Plan, Data Validation Plan, Data Transfer Specifications, etc.) * Creating Actelion Phase I Data Management documents templates and requirement instructions for external service providers * Development of the Clinical Pharmacology Phase I data collection and archiving standard based on CDISC CDASH and SDTM requirements * Evaluation of potential EDC systems for Actelion Phase I trials * Site assessment and feasibility visits at external Data Management and Statistics service providers and providing input for their selection and qualification * Contributing Data Management related details for cross functional study documents such as study protocols and service agreements with external providers

Responsible for all Data Management tasks and activities for Oncology trials of Phase I-III (protocol review, e-CRF set-up and design, database set-up, edit checks definition and programming, data review, data cleaning and query management, data analysis, and trial reporting as well as creation of related documents) - Project data analyses for safety updates and Investigator Brochures - Key User of the company global standard SAS module for analysing and reporting adverse event data of all clinical trials (global user support)

* Part of the project team developing a company global SAS based module for analysing and reporting adverse event data of Phase I-IV clinical trials. * Software validation and documentation following the software development life cycle (contribution to user requirements and functional specifications; creation of traceability matrix and user acceptance test test cases, white-box testing, unit testing) * Supervising and coordinating the user acceptance test * Creation and maintenance of user manual and training material * User training and user support on a national and international level (USA, Japan, France, UK) * Involved in the implementation of SAS V8.2 and the MedDRA terminology

* Monitoring of Clinical Pharmacology Phase I trials for various compounds across Europe (conducting site assessment, feasibility, pre-study, site initiation, monitoring, and close-out visits) * Monitoring of ADME trials, renal impaired patient trials, first entry into men trials, phototoxicity trials, drug-drug interaction trials, in the field of antibiotics, cardiovascular, sleep disorders and immunology * Site management, trial specific training of CRO staff * Preparation and review of study documents and forms * TMF management * Site assessment and feasibility visits of Data Management CROs * Handling and support of Data Management related activities (CRF review and approval, Trial Data transfer documentation review and approval, Data Management Plan review and approval) in close contact with CRO personnel

* Managing, coordinating, and approving all Data Management related tasks and activities for several Phase I Oncology trials internally as well as with various external service providers * Contributing as Project Data Manager to program level clinical meetings and ensure adherence to standards across trials * Support and mentor Lead and Trial Data Managers for allocated trials within assigned project * Representing DM function in several cross functional working group initiatives and activities