À propos de Samira
Analytical, customer-focused Clinical Project Manager with 20+ years’ proven success in dynamic clinical research environments within the pharmaceutical and CRO sectors. Well versed in all aspects of contractual and regulatory compliance, technical documentation and review, budget administration, personnel leadership, and quality control. Highly comfortable in collaborative and independent roles, utilizing open communication with customers, vendors, senior management, and diverse technical teams to establish and achieve shared project objectives.
Allemand
Bilingue ou natif
Anglais
Capacité professionnelle complète
Français
Capacité professionnelle complète
Accepte de travailler sur site
Paris (jusqu’à 50 km)
Expériences
- IPSENFreelance Project Manager, OncologyINDUSTRIE PHARMACEUTIQUEjuin 2025 - décembre 2025 (6 mois)FranceLeading assigned projects from kick off to implementation ensuring adherence to global and local regulations, GDRP and SOPs. Oversees and manages vendors, budgets and change orders. Key Achievement:• Established as key point between internal management, local affiliates and external stakeholders to ensure timely roll-out and achievement of project deliverables.
- ICON PLC,Senior Clinical Trial Manageroctobre 2021 - juin 2025 (3 ans et 8 mois)FranceManaging all clinical operations aspects for all assigned projects, including CRA assignments and allocations; continuous adherence to GCP, SOPs, and contractual regulations for designated projects. Oversees recruitment and site performance, outline study specific processes in project plans and manuals. Regularly liaising with customers and functional leads to define and attain study goals. Supervise and train team of high-performing Clinical Research Associates (CRAs). Key Achievement:• Established as key point of site and CRA contact, to ensure timely achievement of all site study milestones and objectives.• Regular review of processes and plans to ensure the current need and study objectives as agreed with the sponsor are still met• Regular meetings with CRA team to identify non-compliant and underperforming sites; developed contingency plans and risk mitigation strategies to anticipate and eliminate critical issues• review of Budget, TMF and management systems to anticipate and correct critical issues in time
- REAL WORLD, KANTAR HEALTH,Project Managerseptembre 2019 - septembre 2021 (2 ans)FranceMaintain continuous adherence to GCP, SOPs, and contractual regulations for designated projects. Conduct feasibility studies review visit reports to inform detailed project plans. Lead contract and budget negotiations, regularly liaising with customers to define and attain study goals. Supervise and train team of high-performing Clinical Research Associates (CRAs). Key Achievement:• Established as key point of customer contact, bridging the gap between clients and internal management to secure timely achievement of all study milestones and objectives.
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Formations
- Bachelor of Business AdministrationVERWALTUNGS-UND WIRTSCHAFTS-AKADEMIEBachelor of Business Administration
- Anti-Bribery & Corruption Course2019Anti-Bribery & Corruption Course