18.07.2025 aktualisiert
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Project Manager | Digital Systems | GxP, R&D
Zollikerberg, Schweiz
Schweiz
Master of Pharmacy, Master of International BusinessSkills
Java.Net FrameworkUser Experience (UX)Agile MethodologieKünstliche IntelligenzAuditsAutomatisierungGeschäftskontinuitätGeschäftsprozesseProzessoptimierungKorrektur- und VorbeugemaßnahmeChange ManagementBildungstechnologienKlinische ForschungClinical Trial Management SystemSoftwaredokumentationComplianceKontinuierliche QualitätsverbesserungInformation EngineeringDesign ThinkingDigitale MedienDisaster RecoveryEnterprise Resource PlanningStandardverfahrenHelpdeskGute Klinische PraxisLean ProzessePharmazieScrumQualitätsmanagementProzessautomatisierungSAP ApplicationsService DeliverySoftwareentwicklungVaultUser StoriesWorkflowsDigital ComplianceDatenschutzKanbanDatenmanagementReporting-ToolsGXPKpi-Berichterstattung
Employment history
IT Project Manager | Enovos Luxembourg SA
September 2023 - April 2024
May 2022 - April 2023
January 2022 - May 2022
September 2021 - December 2021
September 2018 - September 2021
July 2016 - September 2021
February 2014 - June 2016
IT Project Manager | Enovos Luxembourg SA
September 2023 - April 2024
- Led integration of SAP and Haulogy ERP systems for the French market, aligning business operations, compliance, and master data across departments
- Coordinated cross-functional teams to deliver process harmonization and system interoperability
- Defined and implemented a Disaster Recovery Framework in compliance with NIS v.2 and GDPR, strengthening business continuity and data protection measures
- Initiated and led internal AI automation pilots to streamline documentation workflows and reduce manual effort
- Ensured traceability and audit readiness across digital processes and records
- Facilitated stakeholder engagement and change adoption across IT, legal, and business units
- Supported platform testing, deployment, and documentation standardization for regulated environments
- Delivered continuous improvement initiatives to enhance resilience, reduce risks, and improve digital maturity
May 2022 - April 2023
- Led Agile development of a global R&D Process Portal used by 10,000+ users, driving consistency across documentation, training, and operational access
- Governed lifecycle of Veeva Enterprise Quality Vault SOPs, guides, and forms, ensuring audit readiness and CAPA compliance
- Managed global project delivery: planning, budgeting, scope, risk, performance tracking, and stakeholder alignment
- Collaborated with IT Agile teams to prioritize and implement business-driven system changes
- Owned product backlog, roadmap, and value delivery for cross-functional clinical data domains
- Facilitated UAT, training strategies, and stakeholder engagement for system upgrades
- Oversaw portfolio and escalation processes to senior leadership Applied Lean, Kaizen, Kanban, and Design Thinking to drive process excellence
- Led global SOP/process optimization across Data Management, Clinical Pharmacokinetics, and Data Standards
- Delivered Helpdesk support and change management across all clinical documentation assets
January 2022 - May 2022
- Led a Support Service L1 team (4 FTEs) in a matrixed data engineering environment
- Delivered structured project tracking and milestone execution in data-heavy digital campaigns
- Coordinated delivery of compliance-focused reporting tools across international media accounts
- Acted as single point of contact with leadership, managing risks, resources, and priorities
- Created and implemented a new SLA, improving response times and service quality Applied Lean, Agile, Kanban, and Scrum to optimize delivery and remove impediments
- Contributed to commercial proposals for data automation, aligning plans with client needs Built a learning environment through coaching, mentoring, and lessons learned
- Developed and maintained project documentation, ad-hoc reports, and knowledgebase
- Designed and improved processes, driving automation, quality, and maturity assessments
- Facilitated cross-functional collaboration and built partnerships with tech providers
September 2021 - December 2021
- Managed rollout of an EdTech platform with secure, role-based access and data-sharing protocols
- Oversaw 8 software projects across 4 global IT teams (Java, .NET, Mobile, UX/UI), leading 15+ members
- Led Agile project delivery from initiation to closure, managing scope, time, budget, and team capacity
- Applied Scrum and Kanban to drive sprint planning, backlog grooming, and task prioritization
- Created project documentation, release notes, and executive-ready deliverables
- Defined user stories, acceptance criteria, and training content in collaboration with UX/UI teams
- Translated stakeholder needs into requirements and prototypes; presented outcomes for feedback
- Facilitated improvement workshops and process automation for delivery efficiency
- Managed software development processes and coordinated global calendars and deliverables
- Participated in technical proposal scoping for future platform customization
September 2018 - September 2021
- Led Veeva Vault TMF implementation across 39 countries, integrating TMF, CTMS, and QMS
- Built a Center of Excellence for 500+ users, driving adoption, training, and global support
- Managed full project lifecycle with global oversight of regional managers (EU, AMEA, Americas)
- Directed cross-functional teams (up to 20 people) and facilitated Agile/Scrum events
- Defined KPIs, implemented risk controls, and ensured inspection-readiness
- Collaborated with product owners, developers, and stakeholders to deliver user-focused solutions
- Created and optimized global processes and SOPs for harmonized TMF operations
- Led Kaizen events and applied continuous improvement methodology across regions
- Drove change management and monitored global process metrics
- Delivered global/regional training and contributed to strategy forums in Warsaw
July 2016 - September 2021
- Managed full site lifecycle: start-up, maintenance, and close-out
- Performed all types of monitoring visits ensuring inspection readiness
- Ensured compliance with ICH-GCP, SOPs, and regulatory requirements
- Oversaw site-level study and drug supply management
- Conducted feasibility and investigator selection
- Provided training and ongoing support to site staff
- Ensured timely, accurate SAE reporting and follow-up tracking
- Collaborated with data management to ensure data integrity
- Identified Quality Issues and implemented CAPAs
- Managed Veeva Clinical Vault (CTMS, TMF, ISF) and Veeva Quality Vault
- Maintained audit-readiness of eTMF and site documentation
- Supported preparation for regulatory inspections and audits
- Participated in global and local project team meetings
- Coordinated up to 20 cross-functional local stakeholders
- Oversaw local vendor performance and service delivery
- Monitored digital compliance and escalated data privacy breaches
February 2014 - June 2016
- Supported CRA teams by maintaining eTMF accuracy
- Managing SOP compliance
- Preparing for audits & inspections
- Preparing ISFs for sites
- Preparing Regulatory and IRB-IEC submissions for approval
- Trained clinical monitoring teams in Canada, Poland, Ukraine, Russia, Australia on new application
- Provided training on High Impact Presentation for the company
Sprachen
DeutschGrundkenntnisseEnglischverhandlungssicherRussischMutterspracheUkrainischMuttersprache
Projekthistorie
- Create Project Management Plan
- Lead Design Thinking Workshop for producty requirements
- Set-up Jira for team's needs
- Create supplementary documentation in Confluence (product vision statement, product roadmap, product backlog, sprint backlog, user stories, definition of ready, definition of done, sprint planning notes, burndoen charts, velocity reports, retrospective summary, release notes, risk & issue log, support creation of technical documentation)
- Coordinated data extraction, cleansing, and anonymization to prepare for AI training or prompt tuning.
- Ensured compliance with EU data protection regulations (GDPR), including data minimization and purpose limitation
- Evaluated and selected suitable GenAI platforms or APIs (e.g., OpenAI, Azure OpenAI)
- Designed the AI architecture, possibly integrating with internal systems (e.g., SAP, documentation portals)
- Oversaw prompt engineering, fine-tuning, or custom model integration to meet business-specific needs
- Worked with developers or external vendors to deploy proof-of-concept (PoC) and MVPs
- Led workshops to train employees on safe and efficient AI usage
- Developed internal documentation, governance policies, and acceptable use guidelines for GenAI tools
- Created regular progress reports and presentations for executive stakeholders
- Evaluated PoC outcomes and prepared a scalability plan
- Documented technical workflows and transitioned ownership to operational teams or internal IT
- Collected and analyzed functional and technical requirements for integrating SAP ERP with Haulogy (energy sector software).
- Coordinated with French market stakeholders to validate regulatory and operational needs.
- Defined project scope, success criteria, and key integration touchpoints
- Acted as a liaison between French business users, IT teams, and external vendors.
- Facilitated regular workshops to align cross-functional teams on integration logic, business rules, and data validation
- Oversaw the definition of the data mapping model between SAP modules (e.g., SD, FI, MM) and Haulogy’s structure
- Collaborated with architects to design interfaces, workflows, and automation between both systems
- Managed the end-to-end project plan, ensuring timely delivery of milestones
- Defined and tracked tasks, dependencies, and deliverables using Agile or hybrid project tools
- Led daily stand-ups, sprint planning, and retrospectives if executed in Agile mode
- Defined test plans and acceptance criteria for system and user acceptance testing (UAT)
- Coordinated test case execution, identified gaps, and tracked resolution of integration errors
- Oversaw data migration strategy from legacy systems or between modules
- Ensured data quality checks, compliance with GDPR and internal controls
- Monitored project risks, developed mitigation plans, and escalated critical issues
- Resolved integration challenges related to performance, master data consistency, or automation failures
- Delivered status updates and dashboards to senior management
- Documented lessons learned and contributed to continuous improvement initiatives
- Work within a regulated, critical infrastructure context (energy sector) and requirement to aligning with NIS v.2 (EU directive on cybersecurity of essential services)
- Defined the objectives and scope of the DRP project in line with NIS v.2 directive and internal IT risk policies
- Engaged stakeholders from IT, cybersecurity, legal, and business continuity to align requirements
- Identified critical systems, applications, and data flows essential for energy operations
- Conducted impact assessments to define acceptable Recovery Time Objectives (RTO) and Recovery Point Objectives (RPO) per system
- Assessed cyber, environmental, and operational threats that could lead to disruption
- Documented single points of failure, interdependencies, and potential cascading effects
- Developed a structured Disaster Recovery framework, incorporating:
- Recovery tiers and priority levels
- Fallback procedures (manual operations, secondary data centers)
- Communication trees and escalation flows
- Roles and responsibilities matrix (RACI)
- Integrated with the existing Business Continuity Plan (BCP) and Crisis Management Procedures
- Coordinated with IT teams to define recovery scenarios for cloud, on-premises, and hybrid environments
- Ensured backups, replication, and failover systems were compliant and regularly tested
- Created Standard Operating Procedures (SOPs) and Work Instructions for:
- Disaster event detection and response
- System restoration and data recovery
- User communication and system verification
- Designed and executed DR simulation exercises (tabletop and live failover drills)
- Documented test outcomes, identified improvement areas, and updated DR plans accordingly
- Aligned documentation with NIS v.2, GDPR, and internal audit standards
- Supported internal/external IT audits and provided evidence of DRP controls and testing
- Conducted training sessions and awareness workshops for IT and business users
- Delivered status reports, risk logs, and compliance dashboards to senior leadership
- Established KPIs for recovery performance and readiness
- Created a review cycle to regularly update and test the DRP
- Handover to operational owners with full documentation and governance plan
Zertifikate
Project Management Professional
PMI2023
Complete Agile Project Manager
PMI2023
Lean Green Belt
Lean Institute Ukraine2021