Global Monitoring and Site Engagement

3 giorni fa


Siena SI, Italia GSK A tempo pieno

Global Monitoring and Site Engagement (GMASE) Global Process Owner (GPO) – Clinical Operations
GSK's success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. Where they can keep growing and look after their wellbeing. The GMASE Global Process Owner (GPO) is a senior, clinical operation leader who designs, governs and continuously improves clinical operational processes across GMASE. This role combines end‐to‐end process architecture, change leadership, data and AI‐enabled insights, inspection readiness, and cross‐functional governance to deliver consistent, compliant and measurable outcomes. The GPO owns a network of processes, SOP(s) and tools, drives adoption through strong change management, and partners with country, regional and functional leaders to ensure scalable delivery and performance visibility.
Process Leadership & Governance Act as single process owner for Monitoring and Site Management processes, SOP(s), work instructions and templates, ensuring harmonized, scalable design across Clinical Operations, TMF, Systems and Vendor Oversight, with clear roles and responsibilities that strengthen accountability and transparency across the process network.
Architect and maintain a governance framework that defines oversight, compliance monitoring, role clarity, KPIs and escalation pathways to improve consistency and the end‐user experience.
Define and map end‐to‐end processes, translate strategy into implementable process models, and prioritize improvements based on impact, risk and effort.
Lead GMASE‐wide transformation initiatives (e.g., monitoring oversight, TMF workflows, study training, new platforms), leveraging established methodologies and principles (e.g. Lean/Six Sigma) and AI‐enabled process intelligence to streamline workflows and identify risk patterns.
Change Management, Adoption & Capability Building
Own change management for process rollouts: stakeholder analysis, sponsorship model, communication plans, training strategy and sustainability measures.
Co‐create learning materials, run workshops and coach global/regional/country process stewards and GMASE leaders to build local capability and create change champions.
Data‐Driven Performance & Digital Enablement
Define process KPIs and partner with Business Excellence (BEX) and analytics/IT to build dashboards and automated reporting. Use data to diagnose root causes, prioritize fixes and demonstrate benefit realization. Draw insights from performance data and include them into road map.
Champion digital and AI solutions, working with enterprise taskforces to shape automation and process modernization that support ongoing and future regulation compliance and readiness.
Compliance, Quality & Inspection Readiness
Embed risk‐based controls and oversight mechanisms into owned processes to meet regulatory and quality expectations.
Maintain audit readiness through proactive collaboration with Quality, Regulatory, Data Management, Global Study Team, Safety and Clinical Development.
influence senior stakeholders (VP level and above) to secure resources and drive decisions.
Provide direction to countries, regions, FSP partners and SMEs to ensure consistent global application of processes and standards.
Manage escalations and lead issue resolution for process failures or deviations
Act as a visible leader for GMASE initiatives, demonstrating collaborative, data‐driven and outcome‐focused behaviors.
Preference will be given to candidates located in these hubs, but candidates located near other GSK clinical operations (GMASE) sites will be considered.
Bachelor's degree in Scientific discipline.
Senior leader (Director level and above) with 10+ years in clinical operations, process improvement, quality or related fields, including demonstrable experience leading cross‐functional, global programs.
Proven track record owning clinical operation process landscapes, SOP/WI governance and large‐scale process transformation.
Deep expertise in change management and capability building within matrix organizations.
Data literate and comfortable with analytics, KPI design, dashboards and AI‐enabled process intelligence.
Strong inspection readiness experience, with a track record of supporting major regulatory inspections and delivering compliant outcomes.
Excellent stakeholder management, influencing and facilitation skills; experience engaging senior leadership.
Veeva, CTMS, eTMF), platforms and digital transformation initiatives preferred.
Change Management (Prosci), Lean/Six Sigma, clinical quality/inspection readiness or relevant digital/AI qualifications.
This role is designed for someone ready for a director level role who combines operational credibility in clinical development with strong governance, inspection readiness, data fluency and the ability to lead clinical operation change at scale.
This position is hybrid, with the flexibility to work in the local office 2‐3 days per week.
The annual base salary in Poland for new hires in this position ranges from PLN 437,250 to PLN 728,750 gross. All statutory benefits will be maintained in accordance with Polish law. Other benefits may also be offered, which may include private healthcare, additional paid days off, life insurance, private pension plan and fully paid parental leave & care of family member leave.
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.



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