Jobs at Allucent

Serve as the local pharmacovigilance contact for post-marketing programs: liaise with local regulators, monitor safety and legislation changes, support audits, perform local literature screening, manage risk-minimization and local PV records, report to the EU QPPV, provide PV training, and deliver monthly activity reports for freelance engagements in Poland.

Independently monitor assigned clinical trial sites across study phases, ensure compliance with protocol, GCP/ICH, SOPs and regulations, build site relationships, identify and resolve issues, support regulatory, site activation, contracting and study start-up activities.

Lead and manage CRAs and clinical functions for global or regional trials, ensuring planning, implementation, monitoring, timelines, budgets, quality, training, mentoring, and cross-functional coordination with Project Management and sponsors.

Lead global clinical trials from start-up through closeout, manage cross-functional teams and vendors, ensure GCP and regulatory compliance, control budgets and risks, maintain inspection-ready Trial Master File and stakeholder communication to deliver high-quality multispecialty studies.

Independently monitor and manage assigned clinical trial sites across phases, ensure compliance with protocol, GCP/ICH and SOPs, build site relationships, identify and resolve issues, mentor junior CRAs, and travel throughout the United States to support study integrity and patient safety.

Lead and oversee global oncology clinical trial projects, manage budgets and proposals, ensure quality and compliance (ICH-GCP, privacy, local regs), serve as primary client contact, lead project teams, drive customer satisfaction and continuous process improvement.

Lead and manage clinical data management for studies from database design and set-up through cleaning, validation and database lock. Coordinate with cross-functional teams and external vendors, develop DM plans and standards (CDISC/CDASH), oversee UAT, data transfers/reconciliation, metrics reporting, quality reviews, audits, training and mentoring, and contribute to process and tool improvements and client interactions.

Lead clinical data management activities across study lifecycle including database design, eCRF development, validation, UAT, data cleaning, transfers/reconciliation, metrics reporting, database lock/close-out, vendor/sponsor coordination, and quality/compliance support with focus on regulatory standards and CDM deliverables.

Lead clinical programming for global studies: design, build, validate and maintain clinical databases, edit checks, listings and visualizations; champion CDISC standards; manage timelines/budgets; drive process improvements and mentor junior staff.

Lead clinical programming for global studies: design, build, validate, and maintain clinical databases, edit checks, listings, and visualizations. Ensure CDISC-compliant, inspection-ready deliverables, manage timelines/budgets, drive process improvements, and mentor junior programmers while collaborating with data management, biostatistics, and project teams.

Lead clinical programming for global studies including database design, build, validation, edit checks, listings, and visualizations. Ensure CDISC-compliant, inspection-ready deliverables while managing timelines, budgets, and cross-functional collaboration. Mentor junior staff, drive process improvements, and develop global programming standards and analytics solutions.

Independently lead monitoring for assigned clinical trials (initiation, routine, close-out), ensure compliance with protocol, ICH-GCP, SOPs and regulations, build strong site relationships, identify and resolve site issues, and support regulatory affairs, site activation, contracting, and study-startup. Frequent travel across Germany and collaboration with sponsors and investigators.

Lead population PK/PD modeling and simulation efforts, design and interpret clinical pharmacology studies, provide strategic guidance to clients, author regulatory documents, represent clients in regulatory interactions, mentor pharmacometricians, and support business development and process improvement.

Lead end-to-end CMC strategy for drug substance, drug product, and analytical development from early evaluation through regulatory submission and commercial launch. Author and review CMC submissions, lead Health Authority communications (FDA/EMA/ICH), prepare product development plans through Phase 4, manage and develop direct reports, and provide scientific/regulatory guidance to clients.

Lead cross-functional teams to plan, execute, monitor and deliver clinical trials from start-up through close-out. Manage study documents, TMF, vendors, budgets, risk, and stakeholder communications. Ensure GCP/regulatory compliance, produce status reports, run meetings, and provide project oversight and team development to meet sponsor expectations.

Lead population PK/PD modeling and simulation projects, design and interpret clinical pharmacology studies, mentor pharmacometricians, provide strategic regulatory guidance and author regulatory documents, manage client relationships, and support business development to advance drug development programs.

Serve as a Dynamics 365 Finance & Operations SME bridging finance stakeholders and technology: gather requirements, configure D365 F&O and Supply Chain modules, perform gap analysis, create functional design documents, support UAT and training, and provide operational support across finance application integrations.

Lead monitoring activities for clinical trials across all phases, ensuring compliance with ICH-GCP, protocols, SOPs and regulations. Manage site relationships, site activation/start-up tasks, resolve site issues, and travel throughout Germany to perform initiation, routine monitoring, and close-out visits.

Lead population PK/PD modeling and simulation, design and analyze clinical pharmacology studies, author regulatory pharmacology documents, advise clients strategically, mentor pharmacometricians, and support business development and regulatory interactions.

Lead end-to-end CMC strategy for drug substance, drug product, and analytical development through regulatory submission and commercial launch. Author and review CMC submissions, manage Health Authority interactions, prepare product development plans, and lead and develop staff while ensuring regulatory and quality compliance.