GSK · 9 hours ago
Global Monitoring and Site Engagement (GMASE) Global Process Owner (GPO) — Clinical Operations
Collegeville, PA
Full-time
Hybrid
Director/Executive
10+ years expGSK is a global biopharma company committed to advancing healthcare. They are seeking a Global Process Owner (GPO) for Clinical Operations to lead the design, governance, and continuous improvement of clinical operational processes across their organization.
BiotechnologyHealth CarePharmaceutical
Responsibilities
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
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
Drive sustained adoption through governance, metrics and targeted interventions
Define process KPIs and partner with Business Excellence (BEX) and analytics/IT to build dashboards and automated reporting. Use data to diagnose root causes, prioritise fixes and demonstrate benefit realisation. 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
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
Convene cross‑functional working groups and steering committees; 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
Promote GSK culture and continuous improvement mindset across GMASE functions
Act as a visible leader for GMASE initiatives, demonstrating collaborative, data‑driven and outcome‑focused behaviors
Qualification
Required
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
Operational experience with clinical systems (e.g., Veeva, CTMS, eTMF), platforms and digital transformation initiatives preferred
Preferred
Advanced degree in Scientific discipline
Desirable certifications: Change Management (Prosci), Lean/Six Sigma, clinical quality/inspection readiness or relevant digital/AI qualifications
Company
GSK
We are uniting science, technology and talent to get ahead of disease together. Our community guidelines: https://gsk.to/socialmedia
10001+ employees
H1B Sponsorship
GSK has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (34)
2024 (56)
2023 (55)
2022 (53)
2021 (54)
2020 (72)
Funding
Current Stage
Public CompanyTotal Funding
$25.51MKey Investors
CARB-X
2021-03-02Grant· $18M
2020-09-23Grant· $7.51M
1978-01-13IPO
Leadership Team
Julie Brown
CFO
Mike Elmore
SVP & Chief Information Security Officer, GSK
Recent News
EIN Presswire
2025-11-24
Company data provided by crunchbase