Jobs at WEP Clinical

Manage day-to-day accounting, month-end close, year-end statutory consolidation, audit coordination (including ISAE 3402), multi-jurisdiction VAT/GST compliance, treasury and fixed asset management, intercompany reconciliations, management reporting, credit control coordination, process improvements and ERP enhancements, and deputise for the Finance Manager.

Support setup, implementation, and management of Expanded Access Programs (EAPs). Maintain eTMF and CTMS records, coordinate investigational product shipments, file vendor invoices, manage sponsor/site contact lists, communicate with sites for enrollment, prepare IPRFs for regulatory, and ensure documentation meets FDA/GCP/ICH requirements. Maintain shared documents in OneDrive/SharePoint and enter program/site/patient-level data.

Lead market access client programs across ex-UK/EU markets, delivering pricing, reimbursement, patient access, and regulatory support. Drive proposal development, pricing due diligence, project planning, cross-functional coordination, client presentations, and program delivery to support early access and commercialization strategies.

Lead Clinical Quality Assurance for GCP QMS across global clinical operations and decentralized trials. Oversee QA team, audits/inspections, investigations, CAPAs, vendor oversight, QMS records, quality metrics, and continuous improvement while ensuring regulatory compliance and inspection readiness.

Provide commercial and regulatory legal support for clinical trials, patient access, and pharma commercial activities. Draft, negotiate, and manage contracts (MSAs, vendor agreements, SOWs, clinical trial agreements, sub-distribution), advise leadership on legal risk, support GDPR/data privacy and AI adoption in Legal, improve templates/processes, conduct legal research and proofreading, and act as escalation point for contract and operational legal matters.

Lead and execute cGMP secondary packaging and labeling operations, ensuring audit-ready batch execution, accurate MBR/EBR documentation, label/artwork control, ERP BOM maintenance, vendor coordination, regulatory alignment, and process improvement across global supply chain operations.

Lead QA activities to ensure GxP/GMP/GDP compliance across pharmaceutical distribution and manufacturing. Oversee deviations, CAPAs, change controls, batch reviews, validations, audits, supplier qualification, recalls, documentation, and support client-facing supply projects to protect product quality and patient safety.

Provide GCP quality systems leadership for global clinical operations, overseeing decentralized trial activities, leading investigations and CAPAs, managing risk assessments, reviewing clinical/GCP documents, supporting audits/inspections and vendor qualification, driving QMS improvements, and mentoring QA staff to ensure regulatory compliance and continuous quality improvement.

Lead on-site and remote clinical monitoring and site management for complex studies, ensuring GCP and regulatory compliance, data integrity, and audit-readiness. Mentor CRAs, support site selection, conduct SIVs/close-outs, manage queries and deviations, develop study documents and monitoring tools, and coordinate with sponsors and PMs. Travel up to 80%.

Lead on-site and remote clinical monitoring to ensure protocol, ICH-GCP, and regulatory compliance. Manage site selection, initiation, routine and close-out visits; verify source data and CRFs; review safety and IP accountability; resolve queries and drive CAPAs; train and mentor CRAs; act as primary monitoring contact for sponsors and project teams.

Lead Market Access and HEOR client strategies across evidence generation, pricing, HTA, and value communication; drive business development, manage P&L and key accounts, oversee team and vendor delivery, and enable commercialization and payer access for specialized therapies (Oncology, Cell & Gene, Rare Diseases).