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Malt Strategy
Sandra PacoSP

Sandra Paco

Clinical Study Manager

€800/day
Fontenay-sous-Bois, FR
3-7 years
Risk Management
Leadership
Budget
Regulatory Compliance
Project Management

Average response time: 1 hour

About Sandra

Senior Clinical Project Manager with 10 years of experience in global clinical trials and 6 years in international project and team leadership. Proven track record in delivering complex multinational studies across Europe and international regions, with full ownership of study lifecycle, multimillion-euro budgets, and CRO governance. Recognized for consistent on-time, on-budget delivery, proactive risk mitigation, and effective cross-functional leadership in high-stakes environments (up to 35+ FTE).

  • French

    Native or bilingual

  • English

    Fluent

  • Portuguese

    Conversational

Remote only
Primarily works remotely

Experience

  • APHP
    Clinical Study Manager - Global Clinical Trials
    July 2019 - Today (6 years and 11 months)
    Paris, France
    • Full accountability for end-to-end study lifecycle management (start-up to database lock and close-out)
    • Manage multi-million € study budgets, including forecasting, resource allocation and financial tracking
    • Oversee full-service CRO partnerships, including milestone tracking, KPI monitoring and performance management
    • Chair governance and cross-functional meetings with sponsors, vendors and stakeholders
    • Leadership of 35+ FTE cross-functional teams (Clinical, Data, Regulatory, CRO) in global environments
    • Deliver multiple global trials on time and within budget
    • Reduce operational risks through proactive risk management and CAPA strategies
    • Ensure continuous inspection readiness and regulatory compliance (ICH-GCP)
    Communication
  • APHP
    Clinical Research Associate Lead
    May 2017 - June 2019 (2 years and 1 month)
    • Lead CRA activities across multiple European countries
    • Supervise site initiation, monitoring activities (on-site and remote), close-out visits and ensure quality and compliance across sites
    • Ensure TMF quality control and completeness
    • Identify and manage protocol deviations
    • Train study teams on GCP compliance and deviation reporting
    • Support eCRF testing and data quality oversight
    • Lead TMF quality control and supported audit readiness
  • APHP
    Quality Assurance Lead
    May 2017 - June 2019 (2 years and 1 month)
    Internal audits & TMF compliance
    • Conduct internal audits and TMF quality reviews
    • Develop and implement internal procedures aligned with ICH-GCP requirements
Check out Sandra's experience

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Education

  • DIU FARC-TEC – Clinical Research Associate and Study Coordinator Training
    Sorbonne University
    2017
    DIU FARC-TEC – Clinical Research Associate and Study Coordinator Training
  • Master II
    Sorbonne University
    2016
    Master II
Check out Sandra's education

Skill set

Vendor Management
Clinical Trials

Categories