Senior Manager PCRU Clinical Systems Integration & Governance

JOB SUMMARY • The Senior Manager, PCRU Clinical Systems Integration & Governance serves as the senior professional-track authority for technical integration governance, technology lifecycle oversight and operational reliability of PCRU clinical technology platforms, connected devices and supporting technical environments across the Brussels and New Haven PCRUs. • The role leads and governs complex regulated workstreams spanning platform integration, technical configuration baselines, environment readiness, technical validation strategy, interface assurance, resilience and major-incident coordination. • It partners with Clinical and Data Systems Analysts and operational stakeholders to translate approved clinical, business, workflow and data requirements into sustainable technical requirements, architecture options and implementation approaches. The role works through cross-functional teams and influences stakeholders without formal authority. • The role maintains a close functional working relationship with Digital and Information Management partners and coordinates with Quality, security, infrastructure, application, data engineering, analytics, Digital Solution Engineers, platform owners and vendor teams. • It establishes and maintains appropriate segregation of duties between privileged technical access and the creation, configuration, review or maintenance of clinical, laboratory and operational data. • Accountability for protocol interpretation, study-specific clinical database content, routine study configuration and clinical data review remains within the Clinical and Data Systems Analyst scope. The Senior Manager provides governance of the supporting technical architecture, integrations, environments, security controls, platform lifecycle and operational reliability. • The Senior Manager and Clinical and Data Systems Analyst roles operate as complementary partners across the PCRU clinical technology ecosystem. Their shared involvement at the interface between clinical requirements and technical implementation supports alignment, continuity and successful project delivery without duplicating their respective accountabilities. JOB RESPONSIBILITIES • Own and lead the technical lifecycle governance framework for PIMS, ClinSpark, integrated bedside devices, interfaces, data pipelines and related PCRU technologies, ensuring controlled, reliable and inspection-ready technical operation in partnership with the relevant platform and Digital owners. • Lead risk-based technical impact assessments for proposed changes, enhancements, upgrades and integrations. Develop technical options, document rationale, recommend implementation approaches and align stakeholders on risk controls, technical acceptance criteria and deployment readiness. • Establish and govern technical configuration baselines, controlled deployment standards, version and release controls, environment documentation and technical traceability from approved requirements through testing, implementation, deviation resolution and operational handover. • Lead the technical validation strategy and evidence planning for environments, interfaces, authentication and connected devices in partnership with Quality, system owners and business process owners. Ensure that technical evidence is complete, traceable, defensible and inspection ready. • Define and govern technical build, configuration and readiness standards for LVPP devices, bedside carts, scanners, wristband, label and network printers, Sartorius scales, Philips X3 monitors, Cardiac Stations, ECG devices and comparable future technologies. • Oversee implementation by Digital, engineering, platform or vendor teams against approved technical standards covering device imaging, application deployment, security hardening, calibration interfaces, connectivity, testing and operational handover criteria. • Provide technical governance and readiness oversight for authentication, authorization and secure communications, including single sign-on validation, supported-browser compatibility, Twilio SMS and SendGrid email integrations, in coordination with security, Digital and platform owners. • Lead the structured technical investigation and cross-functional resolution of complex ClinSpark and PIMS integration or pipeline issues involving GPDIP, Databricks, Redshift, Oracle, MySQL, MuleSoft, Cerner and downstream analytics environments. • Coordinate diagnosis by the appropriate Digital, engineering, platform and vendor specialists, ensuring timely escalation, appropriate quality impact assessment, documented decision-making and sustainable corrective action. • Act as the senior PCRU technical liaison with Digital and Information Management, application owners, infrastructure, network, security, data engineering, analytics, Quality and vendors. • Translate approved clinical, data and operational requirements into clear technical requirements, dependencies, governance decisions and implementation options, while ensuring appropriate alignment with enterprise architecture and platform standards. • Lead technical readiness governance for application, agent, Sparkplug, database, server and interface upgrades, including oversight of compatibility assessments, validation approaches, downtime planning, rollback strategies and post-implementation verification by the accountable technical teams. • Establish and govern PCRU technical runbooks, health-check requirements, test matrices, recovery procedures, contingency strategies and support models that strengthen business continuity, service resilience and controlled recovery. • Coordinate PCRU major-incident response and cross-functional root-cause analysis for recurring or high-impact technology failures. Ensure appropriate technical ownership, drive agreed corrective and preventive actions and verify sustainable closure across systems, processes and stakeholders. • Partner with Spotfire, data engineering and downstream reporting teams to coordinate resolution of technical issues affecting data sourcing, ingestion, semantic alignment and refresh reliability. Clinical and Data Systems Analysts retain accountability for clinical interpretation, data fitness and report-content requirements. • Develop, govern and coordinate implementation of approved cross-site technical standards and mid-term technology roadmaps that reduce variability, improve resilience and enable consistent deployment and support practices across PCRUs. • Evaluate emerging technologies and AI-enabled capabilities for technical diagnostics, anomaly detection, forecasting and workflow automation. • Lead the technical governance of controlled technology pilots from feasibility assessment through implementation oversight and benefit review, in partnership with Clinical and Data Systems Analysts, clinical users, data specialists and Digital stakeholders. • Maintain appropriate oversight of vendor technical deliverables, dependencies, risks, documentation, service expectations and handover activities, while ensuring that formal commercial and budget approvals remain with the accountable owners. • Guide and mentor analysts and project contributors on technical standards, structured problem solving, documentation expectations and knowledge sharing, while remaining primarily an individual-contributor role. QUALIFICATIONS / SKILLS • Bachelor’s degree in life sciences, clinical operations, healthcare technology, information systems, data systems, engineering or a related discipline, with at least seven years of relevant experience, or an equivalent combination of education and relevant experience. A master’s degree or relevant professional certification is preferred. • Demonstrated experience in regulated clinical or healthcare systems lifecycle management, technical integration, validation, configuration control, change control and GxP-compliant operational support. • Advanced knowledge of connected-device environments, authentication and authorization, system interfaces, databases, data pipelines, infrastructure dependencies, cybersecurity controls and the governance of structured technical troubleshooting. • Strong working knowledge of GCP and GxP expectations, software development lifecycle principles, computerised-system validation, electronic records and signatures principles, requirements traceability, deviation management and inspection-ready documentation. • Demonstrated ability to lead complex cross-functional projects, work independently in ambiguous situations, apply risk-based judgement, develop practical options and influence senior stakeholders without direct authority. • Demonstrated ability to distinguish and coordinate clinical, data, platform, infrastructure, security and engineering accountabilities within a regulated technology environment. • Excellent written and verbal communication, stakeholder alignment, vendor coordination, documentation, prioritization, mentoring and change-leadership skills. • Experience with relevant technologies such as ClinSpark, PIMS, medical-device integrations, Oracle, MySQL, MuleSoft, Cerner, Databricks, Redshift, GPDIP and Spotfire, or comparable platforms, is preferred. ORGANIZATIONAL RELATIONSHIPS • Reports to the Senior Director, Global PCRU Clinical Services. • Works across the Brussels and New Haven PCRUs with Clinical Services, Clinical Operations, Laboratory, Pharmacy, Business Operations, Quality, study teams, Clinical and Data Systems Analysts, Digital and Information Management, Digital Solution Engineers, application owners, infrastructure and network teams, information security, data engineering, analytics and reporting organisations, technology governance groups and external vendors. • Maintains a close partnership with Clinical and Data Systems Analysts. The Analysts define and validate clinical, workflow and data requirements and own study-facing configuration and data outcomes. The Senior Manager governs the supporting technical architecture, integrations, environments, security controls, lifecycle and operational reliability. • Works with Digital Solution Engineers and other technical specialists responsible for detailed engineering, development and implementation. The Senior Manager provides PCRU technical governance, operational context, standards, risk assessment, readiness oversight and cross-functional coordination rather than duplicating the hands-on engineering remit of those roles. • Influences through technical authority, evidence-based recommendations and cross-functional workstream leadership rather than routine line authority. RESOURCES MANAGED • No routine direct reports are required. • Leads and coordinates complex technical workstreams, project contributors, vendor activities, technology resources, validation deliverables, operational-readiness actions and implementation dependencies. • May guide or mentor analysts and contingent workers. • Provides input to estimates, resource plans and vendor scope; formal budget approval remains with the accountable budget owner. Work Location Assignment: Hybrid (some office presence is required) The closing deadline for applications is October 8th 2026. Pfizer discovers, develops, manufactures and distributes medicines and vaccines. Pfizer wants to contribute to better health and wellness for everyone, at every stage of life. Pfizer works with the government and other health partners to provide quality and accessible healthcare. The patient is central to this story. Pfizer has four offices in Belgium with which it supports its Belgian and international activities: 1) Anderlecht, where the Pfizer Clinical Research Unit is located. This is a fully equipped phase 1 research center. With that of New Haven (US), it is one of two Phase 1 Pfizer research centers in the world, 2) Elsene , the Belgian headquarters, 3) Puurs , Pfizer's production and packaging site, and 4) Zaventem, the international Pfizer's Logistics Center. More information can be found at , and on Facebook and Twitter. Pfizer's aim is to provide equality of opportunity in the recruitment process by avoiding any bias or potential discrimination on any grounds including (but not limited to): sex, age, race, religion or belief, sexual orientation or disability. At Pfizer we are creating an organization and promoting a culture that respects each individual's unique character and life experiences and reflects the diversity of our society, customers and markets. 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