11 sep
|
Almirall
|
Barcelona
11 sep
Almirall
Barcelona
GLOBAL MEDICAL OPERATIONS MANAGERPassa a contenuto principaleQuesto sito web utilizza cookie Questo sito web utilizza cookie propri e di terzi allo scopo di offrire funzionalità di social network e ricavare statistiche. Puoi impostare le tue preferenze per rifiutare o accettare i cookie qui. 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.MissionThe 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 Responsibilities1. Investigator-Initiated Studies (IIS) &
- Global Medical Grants ManagementAct 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 StudiesProvide 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 forums3. 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 scope4.
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 managementEducation University degree in Pharmacy, Biology, Chemistry, Life Sciences, or equivalentExperience 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 integral activities and outcomes* Innovation &
- Simplicity: Seeks practical solutions and continuous improvement* Patient-Centric Mindset: Keeps scientific integrity and patient impact at the coreOur 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.
📌 GLOBAL MEDICAL OPERATIONS MANAGER (Barcelona)
🏢 Almirall
📍 Barcelona