24 ago
|
Almirall
|
Barcelona
24 ago
Almirall
Barcelona
GLOBAL MEDICAL OPERATIONS MANAGERPassa a contenuto principale**Questo 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 noi GLOBAL 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 integral 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 General 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 Integral 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
📌 Global Medical Operations Manager (Barcelona)
🏢 Almirall
📍 Barcelona