18.07.2025 aktualisiert

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Project Manager | Digital Systems | GxP, R&D

Zollikerberg, Schweiz
Schweiz
Master of Pharmacy, Master of International Business
Zollikerberg, Schweiz
Schweiz
Master of Pharmacy, Master of International Business

Profilanlagen

CV - Evgenia van der Pol
I_van_der_Pol_CV.pdf
PMP.pdf
Lean Green Belt.jpeg
Business master.png
Pharma diploma.png
The Complete Agile Project Manager.pdf

Skills

Java.Net FrameworkUser Experience (UX)Agile MethodologieKünstliche IntelligenzAuditsAutomatisierungGeschäftskontinuitätGeschäftsprozesseProzessoptimierungKorrektur- und VorbeugemaßnahmeChange ManagementBildungstechnologienKlinische ForschungClinical Trial Management SystemSoftwaredokumentationComplianceKontinuierliche QualitätsverbesserungInformation EngineeringDatenmanagementDesign ThinkingDigitale MedienDisaster RecoveryEnterprise Resource PlanningStandardverfahrenHelpdeskGute Klinische PraxisLean ProzessePharmazieScrumQualitätsmanagementProzessautomatisierungSAP ApplicationsService DeliverySoftwareentwicklungVaultUser StoriesWorkflowsDigital ComplianceDatenschutzKanbanReporting-ToolsGXPKpi-Berichterstattung
Employment history

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
Associate Director, Business Process Document Manager | AstraZeneca Pharma Poland Sp. z oo
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
Project Manager - Digital media data Andersen Lab | Publicis Media Group (freelancer)
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
IT Project Manager - EdTech | Best Brains Learning Centers (freelancer)
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
Project Manager - Vault TMF implementation | LLC AstraZeneca Ukraine
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
Senior Clinical Research Associate / CRA | LLC AstraZeneca Ukraine
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
Clinical Trial Assistant | LLC AstraZeneca
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

Erfahrung

Berufserfahrungmehr als 10 Jahre
Freelancer seit2021

Sprachen

DeutschGrundkenntnisseEnglischverhandlungssicherRussischMutterspracheUkrainischMuttersprache

Projekthistorie

Generative AI development

Enovos Luxembourg S.A.

Energie, Wasser und Umwelt

>10.000 Mitarbeiter

- 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

SAP & Haulogy Integration Project

Enovos Luxembourg S.A.

Energie, Wasser und Umwelt

>10.000 Mitarbeiter

  • 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

Disaster Recovery Plan Project

Enovos Luxembourg S.A.

Energie, Wasser und Umwelt

>10.000 Mitarbeiter

  • 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

R&D Process Portal development

AstraZeneca Poland

Pharma und Medizintechnik

>10.000 Mitarbeiter

R&D Process Portal Development project was a strategic digital transformation initiative aimed at improving process accessibility, compliance, and collaboration across global R&D functions.
  • Defined project scope, objectives, and success criteria in alignment with global R&D needs
  • Gathered and analyzed user requirements from Clinical, Regulatory, Laboratory and Quality functions
  • Mapped document types (SOPs, WIs, job aids) and metadata structure for taxonomy and tagging
  • Created role-based access control models and workflows for document lifecycle management
  • Acted as Product Owner, writing user stories and managing Agile backlog
  • Prioritized features and coordinated development sprints with IT and vendor teams
  • Oversaw implementation of search, filtering, and navigation features for ease of use
  • Led user acceptance testing, managed feedback loops, and resolved defects
  • Defined document governance rules and compliance checks (e.g., version control, audit trail)
  • Created training materials and conducted onboarding sessions for 10,000+ users
  • Developed communication and adoption plans across departments and regions
  • Tracked portal usage metrics and KPIs to drive continuous improvement
  • Supported inspection readiness through documentation of procedures and controls
  • Transitioned ownership to business units and defined sustainability governance model

Global process development & optimisation

AstraZeneca Poland

Pharma und Medizintechnik

>10.000 Mitarbeiter

  • Collected and consolidated input from cross-functional SMEs to define and draft global SOPs, WIs, and job aids etc.
  • Developed and maintained controlled documentation for new and updated R&D processes
  • Ensured alignment of process documentation with global policies, regulatory guidelines (ICH-GCP, FDA, EMA), and other SOPs
  • Creation of the additional documentation like SIPOC, tracebility matrix, change management log, risk management log
  • Reporting and resolution of the Quality Issues, provision of CAPA
  • Facilitated document lifecycle management using Veeva Vault Enterprise
  • Defined and managed workflows for document creation, review, approval, distribution, and archival
  • Led global stakeholder reviews and approvals across regions and departments
  • Ensured timely updates of controlled documents to reflect process changes and audit findings
  • Supported inspections and audits by ensuring document traceability, version control, and training confirmation
  • Collaborated with process owners to map end-to-end processes and define document hierarchies and relationships
  • Maintained document metadata, ownership assignments, and effective date tracking
  • Created guidance materials to support user understanding and adherence to new or revised processes
  • Coordinated periodic document reviews and re-approvals in accordance with document retention policies
  • Monitored KPIs such as document cycle time, overdue reviews, and compliance to training deadlines
  • Acted as a central point of contact for controlled document governance during transformational initiatives
  • Provided document readiness support for global process rollouts and system integrations
  • Contributed & led multiple Kaizen events

Big data management - Ads reports for global clients

Publicis Media Group

Medien und Verlage

>10.000 Mitarbeiter

  • Managed a team of 4 data engineers and analysts delivering social media advertising performance reports
  • Oversaw data pipeline design, ETL orchestration, and transformation logic using Azure Data Factory and Snowflake
  • Defined data requirements and ensured integration of multiple sources (social platforms, campaign systems, tracking tools)
  • Ensured data quality, completeness, and normalization to support consistent client reporting
  • Led Agile sprints, assigned tasks, and tracked progress using tools like Jira
  • Coordinated report generation and delivery to major clients (e.g., FMCG, pharma, automotive holdings, retail brands) based on KPIs and ad performance
  • Translated complex data outputs into clear dashboards and executive-level insights
  • Acted as main point of contact between internal teams and client data stakeholders
  • Oversaw user access, role permissions, and data governance compliance in Azure and Snowflake
  • Reviewed SQL logic and data transformation scripts to ensure alignment with business rules
  • Handled issue triage, risk mitigation, and team performance tracking
  • Reported project status, blockers, and delivery milestones to senior management
  • Ensured scalability of data architecture to support new clients and larger campaign volumes
  • Supported optimization of existing pipelines and BI dashboards for reporting efficiency

Development of mobile educational apps & portals

BestBrains

Sonstiges

50-250 Mitarbeiter

  • Led the rollout of an educational software platform across multiple franchise centers in the U.S. and Canada
  • Managed a cross-functional team of up to 15 developers, designers, and QA testers across multiple time zones
  • Delivered 3 custom applications and portals for franchise managers, parents, and internal business operations
  • Gathered and translated user requirements from educational, administrative, and business stakeholders
  • Led Agile delivery using Zoho Projects, managing sprints, backlogs, and velocity tracking
  • Applied Scrum methodology, facilitated daily stand-ups, sprint planning, reviews, and retrospectives
  • Defined platform architecture, access models, and data handling policies to support secure operations
  • Gathered requirements from educators, administrative staff, and franchise managers to shape platform functionality
  • Coordinated with software developers to implement features for student tracking, scheduling, and curriculum delivery
  • Managed the access control model to ensure regulated access to student and tutor data
  • Developed project plans with clear milestones, resource allocation, and risk assessments
  • Facilitated training sessions and onboarding for users (teachers, center directors, regional managers)
  • Supported localization and customization of platform features for different regional needs
  • Acted as a liaison between the vendor tech team and the internal operations teams
  • Handled issue triage, user feedback loops, and iterative updates during post-launch
  • Reported platform adoption KPIs, user satisfaction, and performance metrics to leadership
  • Created user guides, training materials, and standard operating procedures for platform use
  • Coordinated software release schedules and QA testing before each deployment wave

Project Manager - Veeva Vault TMF

AstraZeneca

Pharma und Medizintechnik

>10.000 Mitarbeiter

  • Led end-to-end implementation and global rollout of Veeva Vault eTMF across 39 countries
  • Gathered and validated business requirements from Clinical Operations
  • Developed project plans, timelines, and resource allocations following Agile or hybrid methodology
  • Acted as liaison between global business functions and Veeva technical teams to align configuration and workflows
  • Managed system configuration, user roles, metadata models, and controlled document types
  • Oversaw TMF document management and compliance with GxP, ICH-GCP, FDA 21 CFR Part 11, and GDPR in AMEA, EU, Americas
  • Created and maintained SOPs, Work Instructions, and governance frameworks for system usage and documentation standards
  • Trained users (e.g., CRAs, Study Managers, QA staff) on system functionality, inspection readiness, and document handling
  • Supported audit and inspection readiness by ensuring document traceability, completeness, and controlled access
  • Defined KPIs for system usage, document cycle times, and audit findings resolution; presented to leadership
  • Managed change control, issue triage, and enhancement backlog for post-rollout optimization
  • Coordinated with IT Security and Compliance teams to align on access controls, encryption, and disaster recovery
  • Delivered internal reporting dashboards and ensured proper integration with related systems (e.g., LMS, QMS, CTMS)
  • Led training and communications for global user onboarding and version upgrades
  • Supported cross-functional harmonization of processes during onboarding of new countries or business units
  • Led global process optimisations related to the systems and SOPs

Zertifikate

Project Management Professional

PMI

2023

Complete Agile Project Manager

PMI

2023

Lean Green Belt

Lean Institute Ukraine

2021

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