Jobs at Excelya

Conducts on-site and remote clinical trial monitoring for oncology studies, ensuring regulatory, ICH-GCP, protocol, and data-quality compliance. Reviews source documents and medical records, evaluates site performance, tracks protocol deviations and action items, monitors adverse-event queries, and supports inspection readiness. Coordinates with investigators, institutions, site managers, and project teams while managing site-level timelines, communications, and changing priorities.

Leads the document management and migration workstream for an enterprise transformation program. Develops migration strategies, governance frameworks, roadmaps, pilots, migration waves, cost models, budgets, and execution plans. Coordinates business, quality, records management, IT, architecture, procurement, and implementation stakeholders. Provides expert guidance on EDMS migration, records management, information governance, metadata mapping, cleansing, deduplication, validation, and document lifecycle management in regulated industries.

Supports group FP&A through financial forecasting, budgeting, reforecasting, monthly reporting, P&L analysis, variance explanations, KPI reporting, and country-level data consolidation. The role also contributes to EPM implementation, financial systems enhancement, analytics development, automation, and strategic planning support while partnering with finance, operations, and business leaders across countries.

Leads Quality Assurance and Regulatory Affairs for Class II medical devices, maintaining an ISO 13485-compliant quality system, overseeing design controls, risk management, technical files, audits, regulatory submissions, and lifecycle activities. The role defines QARA strategy, monitors EU and US regulatory changes, supports FDA compliance, and collaborates with cross-functional teams and regulatory authorities. Fluency in English and French is required, along with at least 10 years of medical device QARA experience.

Manage and validate in vitro data within the VITRO application. Responsibilities include gathering requirements, functional and technical testing, database quality control, master data imports, data integrity rules, system integrations, documentation, and stakeholder collaboration. The role requires fluent French and English, a relevant master’s degree, and at least five years of data management experience, preferably in preclinical research.

Manage pharmacovigilance case processing from receipt through reporting, including adverse event assessment, quality review, medical consistency checks, signal detection, literature surveillance, regulatory intelligence, periodic safety reporting, and inspection-ready documentation. Collaborate with global safety, medical, clinical, and external stakeholders while supporting PV process improvements, escalation, communication, and regulatory compliance throughout the product lifecycle.

Performs technical data management for clinical studies, including EDC CRF and screen design, data validation plans, edit-check programming, listings specifications, technical documentation, global library maintenance, and quality control. Collaborates with data managers and senior technical staff while ensuring compliance with clinical research regulations, SOPs, and study specifications.

Lead and manage the QA Vigilance & Compliance team to define and implement quality and compliance requirements for vigilance activities. Ensure regulatory compliance (GVP, GMP, ISO), provide quality oversight, manage audits and external partner QA, support regulatory inspections (ANSM, FDA), monitor KPIs, and drive continuous improvement and regulatory intelligence.

Lead the local pharmacovigilance function in Slovakia, ensuring regulatory compliance, safety monitoring, case management, signal detection, risk management, quality systems, audits, inspections, CAPAs, training, vendor oversight, and inspection readiness. Serve as the primary pharmacovigilance contact for health authorities and drive continuous improvement through regulatory intelligence, risk identification, and cross-functional collaboration.

Leads the local pharmacovigilance function, ensuring regulatory compliance and effective safety governance. Serves as the primary contact for Health Authorities and leads inspections, audits, and regulatory interactions. Oversees case management, signal detection, risk management, reporting, quality systems, CAPAs, training, vendor collaboration, and inspection readiness. Drives continuous improvement through risk identification, regulatory intelligence, and stakeholder engagement.

Leads the local pharmacovigilance function, ensuring regulatory compliance, safety monitoring, case management, signal detection, risk management, reporting, quality systems, CAPAs, training, audits, inspections, vendor oversight, and stakeholder engagement. Serves as the primary pharmacovigilance contact for health authorities and drives continuous improvement and inspection readiness.

Leads Hungary’s local pharmacovigilance function, ensuring regulatory compliance, safety monitoring, case management, signal detection, risk management, reporting, quality systems, audits, inspections, CAPAs, training, vendor oversight, and inspection readiness. Serves as the primary contact for Health Authorities and drives continuous improvement through regulatory intelligence, risk identification, and cross-functional collaboration.

As an Oracle Programmer II, you will provide programming input for data management activities, ensuring adherence to client SOPs and quality standards.

As an Oracle Programmer, you'll provide programming support for Data Management, implement data integrations, and ensure quality in clinical programming activities according to client specifications.