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CLINICAL PROJECT MANAGER

Descripción de la oferta de empleo

The Clinical Project Manager (CPM) is responsible for the management of all aspects of Clinical Investigation activities for assigned project(s). The CPM, in concert with the COM (Clinical Operations Manager), is accountable for achieving successful study deliverables at the project level by meeting company and regulatory requirements according to time, quality/scope and budget.Essential Duties and Responsibilities: manage project level operational aspects of Clinical Research studies including management of timelines, budget, resources and vendors.efficient updates on project progress to the Clinical Operations Manager, with respect to vendor selection, project plans, budget and timeline management, quality standards and risks mitigation.sponsor study startup process, including but not limited to conduct of the study Kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Contracts and budgets.effective project plans are in place and operational for each study and work proactively with the COM to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.potential study risks are escalated to the attention of the COM when appropriate.study meetings and vendor status update meetings and ensure meeting minutes are completed, distributed to team members and filed in the Trial Master File (TMF) in a timely manner.site visit reports according to Sponsor Oversight plan; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical teamBudget control with invoicing revision and approval according to executed contractsall project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival proceduresresponses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements.Education/Experience: The ideal candidate will offer: degree in Medicine, Pharmacy or other Health Sciences. Post-graduate studies in clinical research will be very valuable.least 4 years of experience in Clinical Research at a Sponsor or CRO. Must have a thorough knowledge of clinical research concepts, practices, guidelines and regulations covering early phase trials (Phase I-II) and Phase III trials.in Non Interventional Studies will be very valuablehigh level in reading, speaking, and writing (B2 or higher).Excellent verbal and written communication skillsOffice (intermediate-high level).Other:Travel availablity: 30%
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Detalles de la oferta

Empresa
  • ROVI Pharma Industrial Services
Localidad
  • En toda España
Dirección
  • Sin especificar - Sin especificar
Fecha de publicación
  • 11/05/2024
Fecha de expiración
  • 09/08/2024
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