Daniela Pobinger Email & Phone Number

Wien, Österreich

• Manage protocol registration and results preparation for public disclosure, e.g. in EU Clinical Trials Registry (EU CTIS/EudraCT), US Registry (ClinicalTrials.gov) and EU PAS Register• Define, implement and manage processes for data transparency initiative and redaction of documents to protect personal data and commercially confidential information, e.g. under EMA Policies 0043 and 0070 or posting on Clinical Trial Transparency (CTT) website• Interpret and apply global regulatory authorities regulations and guidances

Vienna

• Manage protocol registration and results preparation for public disclosure, e.g. in EU Clinical Trials Registry (EudraCT), US Registry (ClinicalTrials.gov) and EU PAS Register• Define, implement and manage processes for data transparency initiative and redaction of documents to protect personal data and commercially confidential information, e.g. under EMA Policies 0043 and 0070 or posting on Clinical Trial Transparency (CTT) website• Interpret and apply global regulatory authorities regulations and guidances

Vienna

• Manage protocol registration and results preparation for public disclosure, e.g. in EU Clinical Trials Registry (EudraCT), US Registry (ClinicalTrials.gov) and EU PAS Register• Define, implement and manage processes for data transparency initiative and redaction of documents to protect personal data and commercially confidential information, e.g. under EMA Policies 0043 and 0070 or posting on Clinical Trial Transparency (CTT) website• Interpret and apply global regulatory authorities regulations and guidances

Vienna

• Manage protocol registration and results preparation for public disclosure, e.g. in EU Clinical Trials Registry (EudraCT), US Registry (ClinicalTrials.gov) and EU PAS Register• Define, implement and manage processes for data transparency initiative and redaction of documents to protect personal data and commercially confidential information, e.g. under EMA Policies 0043 and 0070 or posting on Clinical Trial Transparency (CTT) website• Alliance Manager for contract research organizations (CRO): contract setup; development, monitoring and reporting of key performance indicators (KPIs)• Interpret and apply global regulatory authorities regulations and guidances• Prepare Standard Operating Procedures (SOPs)• Train and coach new CTT team members

Vienna

• Manage results preparation and upload for clinical trials registers (e.g. EudraCT) • Define, implement and manage processes for document redaction for data transparency initiative • Project tracking and metrics preparation• Alliance Manager for Indian CRO: contract setup; development, monitoring and reporting of key performance indicators (KPIs)• Prepare Standard Operating Procedures (SOPs)• Close teamwork with US and UK counterparts

Vienna

• Manage EU Clinical Trials Registry & Data Transparency Group: performance feedback; training and development; task allocation to team members; prioritization in time-critical projects• Manage results preparation and upload for EU Clinical Trials Registry (EudraCT) • Define, implement and manage processes for document redaction for data transparency initiative• Alliance Manager for Indian CRO: contract setup; development, monitoring and reporting of key performance indicators (KPIs)• Prepare Standard Operating Procedures (SOPs)• Close teamwork with US and UK counterparts

Vienna

• Management of CDM team: performance feedback; training and development; task allocation to team members; prioritization in time-critical projects• Management of external contractors and contract research organizations (CROs) • Alliance Manager for Indian CRO: contract setup; development and monitoring of key performance indicators (KPIs); quarterly reporting of KPIs to Steering Committee• Providing senior expertise for CDM activities• Preparation of Standard Operating Procedures (SOPs)• Core Team Member in Business Process Improvement initiative• Budget, timelines and resource planning• Evaluation of new technologies for continuous CDM improvement• Close teamwork with US counterparts

Vienna

• Management of CDM team• Management of external contractors and CROs• Providing expertise for CDM activities• Preparation of SOPs• Assist in budget, timelines and resource planning• Managing all CDM tasks for clinical studies: Lead the design, creation and lifecycle management of data collection, validation and reporting specifications, including: Case Report Form (CRF) design and flow definition; database setup and validation; data review and cleanup including query management (query creation, processing and tracking) and coordination of periodic project data review discussions; data reporting; and execution of database extracts/locks

Glendale, Los Angeles, Ca

• Performing all CDM tasks for clinical studies

Vienna

• Performing all CDM tasks for clinical studies• Identification and resolution of data handling and data management issues• Participation in project team meetings and partnering with Clinical Operations, Biostatistics and Therapeutic Areas• Preparation of project archiving (documentation and database)

Vienna

• Statistical analysis of preclinical studies: database design; data review; select appropriate analysis method; data analysis; preparation of result summary• Creation of standard CRFs• Performing all CDM tasks for clinical studies

Magister Der Sozial- Und Wirtschaftswissenschaften (M.Sc.), Statistics

Matura (Final Examination Qualifying For University Entrance), Secondary School Specializing In Modern Languages