03 ago
|
Almirall
|
Barcelona
03 ago
Almirall
Barcelona
GLOBAL MEDICAL OPERATIONS MANAGERPassa a contenuto principale
Siga leyendo para comprender completamente lo que este trabajo requiere en cuanto a habilidades y experiencia. Si su perfil encaja, presente su candidatura.
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Per ulteriori informazioni, consulta la nostra Politica sui cookie.# Lavora con noiGLOBAL MEDICAL OPERATIONS MANAGER page is loaded## GLOBAL MEDICAL OPERATIONS MANAGERPresenta candidaturaremote type: R&D; & Medical Affairslocations: BARCELONAtime type: Full timeposted on: Offerta pubblicata oggijob requisition id: Stiamo costruendo il futuro della dermatologia medica concentrandoci sui bisogni ancora insoddisfatti dei pazienti e dando alle persone lo spazio per pensare in modo indipendente, assumersi responsabilità e generare un impatto che conta davvero.Il nostro purpose è semplice: trasformare la vita dei pazienti rispondendo a bisogni reali.
Lavoriamo con rigore, agiamo con coraggio, teniamo le cose semplici e orientiamo l’innovazione dove può davvero fare la differenza.Riconosciuti come Top Employer in Spagna dal 2008 e in Germania dal 2025, continuiamo a investire in un ambiente in cui le persone possono crescere e andare avanti.Se pensi in modo diverso, qui è il posto giusto per te.
**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
**general 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) xqbhyrx 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### La nostra ambizione è chiaraStiamo costruendo il futuro della dermatologia medica concentrandoci sui bisogni ancora insoddisfatti dei pazienti e dando alle persone lo spazio per pensare in modo indipendente, assumersi responsabilità e generare un impatto che conta davvero.Se pensi in modo diverso, qui è il posto giusto per te.
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📌 GLOBAL MEDICAL OPERATIONS MANAGER (Barcelona)
🏢 Almirall
📍 Barcelona