Über Mansour
Clinical Project Manager | Global Trials Delivery | Medical Affairs | Expert in Early Phase & Real World Evidence Generation
Senior Global Clinical Operations Leader with more than 20 years of experience managing complex international clinical trials across early development, late-phase, and real-world evidence programs.
I have worked within top pharmaceutical companies (Bristol Myers Squibb, Sanofi, Ipsen) and global CRO environments, leading global study delivery across Europe, and North America.
My expertise includes:
- Global clinical trial leadership (Phase I–IV)
- Real-world evidence and post-marketing studies (RWE, PMS, PASS, Registries, Charts)
- CRO and vendor governance
- Clinical program operational strategy
- Budget oversight and financial planning
- Regulatory inspection readiness (FDA / MHRA)
I have successfully supported gene therapy, oncology, rare disease, neuroscience, vaccine, ophtalmology, and immunology development programs, including participation in regulatory inspections and IND / NDA approval processes.
I provide consulting and interim leadership support to biotech, pharmaceutical companies, and CROs, helping teams deliver complex global trials efficiently and compliantly.
Englisch
Muttersprachlich oder zweisprachig
Französisch
Muttersprachlich oder zweisprachig
Vor Ort möglich
Paris (bis zu 50 km), Saint-Louis (bis zu 50 km)
Projekt- und Berufserfahrung
- BRISTOL MYERS SQUIBB (HQ) | SwitzerlandSenior Global Trial ManagerPHARMAZEUTISCHE INDUSTRIEDezember 2022 - Februar 2025 (2 Jahre und 2 Monate)Neuchâtel, Schweiz
- Led operational delivery of four global Phase I/II trials, ensuring alignment across internal teams, CROs, and vendors in complex multinational clinical development programs.
Key contributions:- Directed cross-functional global trial teams across clinical operations, data management, safety, regulatory, and biostatistics
- Provided operational input into protocol design, operational plans, and study execution strategy
- Managed country CTMs and global trial teams, tracking metrics and implementing mitigation plans
- Oversaw CRO and vendor governance, including IRT, central laboratories, imaging vendors, and ancillary services
- Contributed to clinical data review, deviation assessment, database lock preparationDBL / TFL / TOC, and CSR clinical study reporting
- Managed global study budgets including forecasting, scope changes, financial reconciliation, and cost variance analysis
- Coordinated site inspection readiness and QA audits, implementing corrective and preventive actions (CAPA)
- Ipsen Innovation, (HQ) | ParisSr. Global Clinical Project ManagerPHARMAZEUTISCHE INDUSTRIEOktober 2021 - November 2022 (1 Jahr und 1 Monat)Oversaw global clinical trial delivery in neuroscience early-phase programs including PK and DDI drug-drug interaction studies.Key responsibilities:
- Supervised CRO delivery and vendor performance
- Contributed to Bid defense and vendor selection (RFPs, SoW, CiS)
- Contributed to protocol development and operational study planning
- Developed and tracked study timelines, milestones, and financial planning
- Managed operational performance KPIs metrics and escalation processes
- Sanofi-Aventis (Global Headquarters) | ParisGlobal Study Manager LeaderAugust 2018 - Oktober 2021 (3 Jahre und 2 Monate)Led cross-functional global teams delivering gene therapy and rare disease clinical trials.Key achievements:
- Managed global trial operations for ophthalmology gene therapy programs and Pompe Rare disease trials
- Coordinated cross-functional teams across clinical, regulatory, and data functions
- Supervised CRO and vendor delivery from site activation through close-out
- Supported FDA Pre-Approval Inspection (PAI, BIMO) activities (FDA NDA approval of Nexviazyme® (2021)
- Participated in regulatory MHRA inspection interviews and CAPA implementation
- Supported clinical data review including safety reconciliation, deviation analysis, and database lock
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Ausbildung und Abschlüsse
- PMP® PMIORSYS