• Establishing a harmonized data platform hosting E2E technical and therapy-related device data across all business fields whilst ensuring the implementation of global product compliance and security requirements as L2 business transformation target
• Responsible for stakeholder management, phased planning and global rollout,  harmonizing and aligning global requirements, leading technical and infrastructural activities, ensuring global compliance
• Manage business requirement collection, interfacing to portfolio managers,  product owners, project managers, system architects across all verticals Home, In-Center and Critical Care, product data governance, complaint investigation, post-market surveillance, manufacturing, technical support data protection & privacy, legal, security

• System implementation for analytics of drug substance and drug product data
• Responsible for budget, resources, planning; Interfacing to Business, Laboratory, Procurement, IT Security, Data Privacy, Quality team and Contractor (vendor)
• Manage business requirement collection, RfP and vendor proposal phase, contract negotiation, supervise supplier audits, ensure project and system compliance, supervise design, build and transition phase

Medical Information, Medical Writing, Patient Safety

Healthcare ? R&D Strategic Initiative
Global Clinical Development, Clinical Trial Transparency

• Program Management
• Responsible for budget, resources, planning; Interfacing to Business, Procurement, IT Security, Data Privacy, Quality team and Contractors (CROs, other vendors)
• Project Trial Awareness and Transparency ? manage implementation of global trial finder and trial education website
• Project Digital Patient Recruitment ? manage implementation of measures of digital outreach to potential patients, partnering with pilot study in therapeutic area of neurodegenerative diseases
• Project Patient Retention ? manage implementation of mobile app and concierge service to keep patients engaged during a clinical trial, partnering with pilot study in therapeutic area of oncology
• Project Program Website Wireframe ? manage and execute development of framework concept for implementation of global compound websites

• Enhancement of clinical services 
• Coordination of interfaces to clinical services, improve clinical processes 
• Miscellaneous platforms

• Global Platform Unification Strategy 
• Project Manager 
• Coordination with client?s program and project management, internal resource planning, forecasts and scorecards to program management, global strategy, requirements engineering, workshops 
• Open Text D2 4.x and LSS 4.x (LSQM, LSRnD, SSV)

• Global implementation of contract lifecycle management system (Australia, Germany, Switzerland and USA) 
• Technical Manager, Validation Responsible and Project Management Delegate 
• Create and maintain project management plan, coordinate technical teams, coordinate data migration, mapping and cleansing activities, lead integration of eSignature interface, lead integration of SAP vendor and customer interface, manage and conduct overall system validation 
• Axicos Carizma 2.x/3.x, DocuSign, SAP

• Introduction of document management system 
• Coordinate configuration, customization, installation and migration activities with client, resource planning, provide monthly forecasts and weekly scorecards to program management 
• Open Text D2 4.5 and LSS 4.1 (LSQM + LSRnD)

• Training materials 
• Design and create videos and wiki articles for global SharePoint rollout in English and German language

• Global permission concept 
• Identity Management specialist 
• Extend global permission concept valid for any platform storing and administrating digital identities by Documentum specifics to achieve higher security level 

• Introduction of document management system 
• Business coordinator and trainer 
• Data migration advice, rule-setting and training of key users, department trainings, SPOC (single point of contact) regarding business requests of divisions, assessing change requests and accompanying system handover into operations, recommendation, design and implementation of cross-departmental procedures to simplify workflows, introducing functional interfaces, content management consulting across miscellaneous platforms (Documentum, SharePoint, internal expert system, file system)

• Management dashboard introduction 
• Validation Responsible 
• Validate management dashboard project gathering data from miscellaneous information management systems such as SAP, LIMS and Excel crucial to monitor production deviations (GAMP5 category 4) 

• Management dashboard introduction 
• Validation Responsible 
• Validate management dashboard project gathering data from miscellaneous information management systems such as SAP, LIMS and Excel crucial to monitor production deviations (GAMP5 category 4)

• Clinical Trial Management 
• Access Management specialist, analyst, trainer 
• Design and implement permission concept based on site collections for global trial document management and report exchange; train sites in using this solution