À propos de Helene
Why work with me?
How I can help you?
- Program/Project Management : steering clinical, regulatory, or quality projects; planning, budgeting, and vendor coordination.
- Vendor Management : CRO/CMO selection and oversight, KPI implementation, document audit management, GxP compliance.
- Digital Rollout & Training : deployment of digital tools (ERP, Veeva, SharePoint), user training, change management, and design of dedicated training campaigns.
Anglais
Bilingue ou natif
Français
Bilingue ou natif
Expériences
- Bristol Myers Squibb UKMarket Access & Public Health - Project managerINDUSTRIE PHARMACEUTIQUEseptembre 2024 - août 2025 (11 mois)Rueil-Malmaison, France
- Clinical project support (non-interventional trial): coordinated between public institutions (FIAC) and private vendors/CROs to select, activate, and monitor trial sites. Ensured timelines and compliance for study launch.
- Contract drafting & negotiation: drafted and refined contracts to clarify scope, deliverables, and data protection. Aligned legal and procurement terms across vendors, scientific committees, and investigator sites.
- Stakeholder alignment: acted as liaison between legal, procurement, and scientific stakeholders, ensuring contract terms matched institutional policies and regulatory requirements.
- Consensus building & project initiation: facilitated structured discussions to balance scientific objectives with operational constraints, leading to successful study approval and initiation.
- Cencora (PharmaLex)Program CoordinatorINDUSTRIE PHARMACEUTIQUEjanvier 2017 - juillet 2024 (7 ans et 6 mois)Mannheim, Allemagne
- Project governance & execution : built and executed roadmaps, implementation plans, and reporting frameworks (meeting minutes, status reports, KPIs) to keep programs on track.
- Team leadership in matrix setups : led and mentored cross-functional project teams (up to 20 people), ensuring alignment and high performance across regulatory, clinical, and operations.
- Vendor management & onboarding : selected, onboarded, and trained vendors, maintaining performance through structured oversight and clear communication.
- Contract & budget oversight : reviewed SOWs/PSAs, supported invoicing, and monitored project profitability via ERP (Microsoft Dynamics 365).
- Cross-functional delivery : coordinated outsourcing programs (regulatory submissions, NDA planning, end-to-end local outsourcing) to achieve client and business objectives.
- PfizerProject coordinator (QA)INDUSTRIE PHARMACEUTIQUEoctobre 2015 - décembre 2016 (1 an et 3 mois)London, Royaume-Uni
- Data migration & compliance monitoring : analyzed and tracked MAA data migration into a new eDMS system, ensuring accuracy and completeness during system launch.
- Training & onboarding : designed communication plans and educational materials, training global and regional regulatory teams on compliant data entry.
- Change management support : supported adoption of new digital processes, improving data quality and compliance across multiple regions.
Recommandations
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Formations
- Master of Science Drug Discovery & Pharma managementUniversity College London2015Master of Science
Certifications
- PMI Agile Certified practionner (PMI-ACP)Linkedin Learning2023