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.
• 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.
• 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.
• 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.
• 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

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.

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