Global Medical Operations Manager

Almirall
Almirall
BARCELONAPresencialCompetitivoPublicado ayerSeniorIndefinidoRemoto: On Site
🇬🇧Inglés requerido

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We're building the future of medical dermatology by focusing on unmet patient needs and giving people the space to think independently, take ownership and make an impact that matters.

Our purpose is simple: to transform patients' lives by addressing real needs. We work with care, act with courage, keep things simple and focus our innovation where it makes a difference.

Recognised as a Top Employer in Spain since 2008 and in Germany since 2025, we continue to invest in an environment where people can grow and move forward.

If you care differently, you belong here.

Mission

The Global Medical Operations Manager is responsible for the operational planning, coordination, and oversight of Global Medical Affairs studies, with a strong focus on Investigator-Initiated Studies (IIS), Phase IV / non-interventional studies, and Real-World Evidence (RWE) initiatives.

The role ensures end-to-end operational excellence, compliance, transparency, and cross-functional alignment across global and local teams, enabling timely evidence generation to support Global Medical strategy.

Key Responsibilities

1. Investigator-Initiated Studies (IIS) & Global Medical Grants Management

Act as the global operational owner for IIS and selected global medical grants:

  • Serve as primary operational point of contact for globally supported IIS
  • Coordinate IIS activities across Legal, Compliance, Finance, Clinical Trial Supply, R&D, IP, CROs, global and local teams
  • Lead and coordinate:
    • Contract generation and execution with HCPs/HCOs
    • Amendment management in collaboration with Legal and affiliates
    • Budget monitoring and reporting
  • Maintain global IIS master documentation, including:
    • Proposals and approvals
    • Agreements and amendments
    • Invoice tracking and payment documentation
    • Final report/publication tracking (links or references, as applicable)
  • Track study progress, milestones, and deliverables in collaboration with affiliates
  • Manage the full invoice and payment lifecycle, ensuring timely and accurate processing
  • Ensure transparency reporting for global IIS and grants in applicable systems (e.g. Veeva), in line with local legislation (with particular attention to high-complexity markets such as France and the US)
  • Provide quarterly IIS KPI reporting in line with Global Medical Affairs guidance
  • Support pharmacovigilance requirements by ensuring IIS operational data is available for PSUR, DSUR, and PSMF activities (upon request and per SOP)

2. Global Phase IV, RWE, and Non-Interventional Studies

Provide operational experience and support for Global Medical evidence generation initiatives, including RWE:

  • Support the planning, execution, and oversight of company-sponsored Phase IV, low-interventional, and non-interventional studies
  • Act as the main operational contact for CROs, ensuring quality, timelines, and budget adherence
  • Support Global Medical Leads in delivering evidence aligned with Brand Plans and Medical Strategy
  • Track and maintain an overview of globally sponsored and locally executed GMA studies, ensuring visibility, consistency, and governance
  • Maintain accurate and timely study updates to support:
    • Pharmacovigilance reporting
    • Public registry disclosure obligations
    • Internal governance and decision-making forums

3. Cross-Functional Governance & Stakeholder Engagement

  • Actively participate in Phase IV / IIS Review Committee when IIS proposals are presented and discussed
  • Coordinate follow-up actions after IIS approval and ensure alignment across stakeholders
  • Collaborate closely with:
    • Global and Local Medical Affairs teams
    • Finance (budget tracking and long-term projections)
    • Global Compliance and QA
    • Legal (for contracts)
    • CRO partners and external vendors
  • Contribute to medical operations updates, including internal communication updates, enabling informed decisions within Global Medical Affairs
  • Attend selected scientific meetings, operational forums, and internal trainings as relevant to role scope

4. Process Optimization, SOP Ownership & Digital Innovation

  • Lead the review, update, and implementation of key Medical Operations SOPs related to studies
  • Maintain and update the Medical Operations Hub and study-specific operational pages, ensuring accuracy, relevance, and alignment with Global Medical needs
  • Proactively identify opportunities for digital solutions and emerging technologies (e.g., workflow automation, analytics, AI-assisted processes) to improve efficiency and data quality in studies management

Education

  • University degree in Pharmacy, Biology, Chemistry, Life Sciences, or equivalent

Experience

  • Proven experience in:
    • Clinical operations, medical operations, or study management
    • Phase IV, non-interventional, or RWE studies
    • Cross-functional coordination in a global matrix environment
  • Solid understanding of:
    • Transparency and compliance requirements
    • Study governance and lifecycle management
  • Experience in Dermatology or related therapeutic areas is an asset
  • Fluent in English (written and spoken)

Competencies & Values

  • Operational Excellence: Structured, detail-oriented, and delivery-focused
  • Collaboration: Able to work effectively across functions, cultures, and geographies
  • Ownership & Accountability: Takes responsibility for global activities and outcomes
  • Innovation & Simplicity: Seeks practical solutions and continuous improvement
  • Patient-Centric Mindset: Keeps scientific integrity and patient impact at the core

Our Values

  • Care - We listen, empathize, and support each other
  • Courage - We challenge the status quo and take ownership
  • Innovation - We create meaningful, patient-centered solutions
  • Simplicity - We act decisively and keep things clear and effective

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