14 ago
|
Almirall
|
Barcelona
14 ago
Almirall
Barcelona
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. 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 IISCoordinate IIS activities across Legal, Compliance, Finance, Clinical Trial Supply, R&D;, IP, CROs, global and local teamsLead and coordinate:Contract generation and execution with HCPs/HCOsAmendment management in collaboration with Legal and affiliatesBudget monitoring and reportingMaintain integral IIS master documentation, including:Proposals and approvalsAgreements and amendmentsInvoice tracking and payment documentationFinal report/publication tracking (links or references, as applicable)Track study progress, milestones, and deliverables in collaboration with affiliatesManage the full invoice and payment lifecycle,
ensuring timely and accurate processingEnsure 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 guidanceSupport 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 studiesAct as the main operational contact for CROs, ensuring quality, timelines, and budget adherenceSupport Global Medical Leads in delivering evidence aligned with Brand Plans and Medical StrategyTrack and maintain an overview of globally sponsored and locally executed GMA studies, ensuring visibility, consistency, and governanceMaintain accurate and timely study updates to support:Pharmacovigilance reportingPublic registry disclosure obligationsInternal governance and decision-making forums 3. Cross-Functional Governance & Stakeholder EngagementActively participate in Phase IV / IIS Review Committee when IIS proposals are presented and discussedCoordinate follow-up actions after IIS approval and ensure alignment across stakeholdersCollaborate closely with:Global and Local Medical Affairs teamsFinance (budget tracking and long-term projections)Global Compliance and QALegal (for contracts)CRO partners and external vendorsContribute to medical operations updates, including internal communication updates, enabling informed decisions within Global Medical AffairsAttend selected scientific meetings, operational forums, and internal trainings as relevant to role scope4. Process Optimization, SOP Ownership & Digital InnovationLead the review, update, and implementation of key Medical Operations SOPs related to studiesMaintain and update the Medical Operations Hub and study-specific operational pages, ensuring accuracy, relevance, and alignment with Integral Medical needsProactively identify opportunities for digital solutions and emerging technologies (e.g., workflow automation, analytics, AI-assisted processes) to improve efficiency and data quality in studies managementEducationUniversity degree in Pharmacy, Biology, Chemistry, Life Sciences, or equivalentExperienceProven experience in:Clinical operations, medical operations, or study managementPhase IV, non-interventional, or RWE studiesCross-functional coordination in a global matrix environmentSolid understanding of:Transparency and compliance requirementsStudy governance and lifecycle managementExperience in Dermatology or related therapeutic areas is an assetFluent in English (written and spoken)Competencies & ValuesOperational Excellence: Structured, detail-oriented, and delivery-focusedCollaboration: Able to work effectively across functions, cultures, and geographiesOwnership & Accountability: Takes responsibility for global activities and outcomesInnovation & Simplicity: Seeks practical solutions and continuous improvementPatient-Centric Mindset: Keeps scientific integrity and patient impact at the coreOur ValuesCare – We listen, empathize, and support each otherCourage – We challenge the status quo and take ownershipInnovation – We create meaningful, patient-centered solutionsSimplicity – We act decisively and keep things clear and effectiveSummaryLocation: BARCELONAType: Full time
📌 GLOBAL MEDICAL OPERATIONS MANAGER (Barcelona)
🏢 Almirall
📍 Barcelona