Jobs at WEP Clinical

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).

Lead site QA for manufacturing and distribution (secondary packaging & labeling), ensure compliance with GMP/GDP and QMS, oversee deviations/CAPAs/change control, perform warehouse reviews, host audits/inspections, approve batch records, conduct risk assessments, and manage and develop the QA site operations team while working with cross-functional stakeholders.

Lead site quality assurance for manufacturing and distribution activities, ensuring compliance with GMP/GDP and QMS. Oversee deviations, CAPAs, batch record reviews, warehouse responsibilities, risk assessments, audits, and cross-functional coordination. Coach and develop QA site team to deliver compliant clinical trial and expanded access supply services.

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.