Local SSU Project Manager - Sponsor Dedicated en COVANCE

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Local SSU Project Manager - Sponsor Dedicated

Fecha de la oferta: 10 Ago.
Empresa que publica esta oferta: COVANCE
Ver todas sus ofertas de empleo (2)
As the drug development business of Laboratory Corporation of America Holdings (LabCorp) and the world’s most comprehensive drug development service company, we have helped pharmaceutical and biotech companies develop 100% of the top 50 prescription drugs in the marketplace today.

Because of our broad experience and specialized expertise, we’re in a unique position to supply insights that go above and beyond testing. Together with our clients, we create solutions that transform potential into reality.
Número de vacantes: 1
Provincia/s: Madrid

Descripción

Descripción: Covance is looking for a SSU Project Manager to work 100% dedicated to one of our clients which is a leading pharmaceutical company.

Check out the role responsibilities and requirements below:

The Senior SSU & Regulatory Specialist is accountable for execution and oversight of local operational clinical trial activities in a country for assigned protocols in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

FINANCIAL:
Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA). Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value. Oversight and tracking of clinical research-related payments. Payment reconciliation at study close-out.
Oversight of FCPA, Denied Parties Screening and maintenance of financial systems. Financial forecasting and tracking of operational budget in conjunction with CRD.

COUNTRY SUBMISSIONS & LOCAL LANGUAGE MATERIALS:
Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.
Development of local language materials including local language Informed Consents and translations.
Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.

MANAGEMENT & QUALITY OVERSIGHT:
Responsible for managing country deliverables, timelines and results for assign
Tipo de contrato: Indefinido
Ventajas sociales o económicas: Ticket Restaurant
Life Insurance
Medical Insurance
Observaciones: Office based at the Sponsor offices.

Requisitos

Requisitos: Strong experience in SSU and Regulatory submissions
Experience with contracts
Protocol amendments
Nivel de estudios mínimo requerido: Licenciado
Idiomas requeridos: Inglés nivel Alto.
Experiencia profesional mínima requerida: 4 años
Disponibilidad para viajar requerida: Ninguna

Comparte esta oferta:

Esta oferta ha recibido 21 inscripciones.