Clinical Trial Manager Ii

Detalles de la oferta

.As a Local Trial Manager, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.The LTM is the primary point of contact at a country level for assigned studies. The LTM is responsible for coordinating and leading the local trial team in order to deliver quality data and trial documents/records that are compliant with assigned protocol, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs) and regulatory requirements. LTM actively contributes to process improvement; training and mentoring of Clinical Trial Assistants, CRAs and LTMs. The LTM may have some site management responsibilities.What you will be doing: Is responsible for country do-ability and site feasibility assessment in conjunction with CTA, CRA and PM. Implements any local criteria for site selection. Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report. Recommends suitable sites for selection to participate in trial.Collaborates with the CPL, PM, local management/Country Head and Protocol Owner to select final site list.Contributes input to the Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level or initiates development of these plans for a single country trial.Leads and coordinates local trial team activities in compliance with GCO Standard Operating Procedures (SOP), Work Instructions (WI) and applicable regulations. Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.Ensures that all SAEs/PQCs are reported within reporting timelines and documented as appropriate.Maintains and updates trial management systems (e.G. CTMS, eTMF/LAF, Trial Master Source and Sharepoints). Uses study tools and management reports available to analyze trial progress.Monitors country progress and initiates corrective and preventive actions when the trial deviates from plans and communicates study progress and issues to study management teams.May submit requests for vendor services and may support vendor selection.May lead negotiation of trial site contracts and budgets. Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered -within budget. Adheres to finance reporting deliverables and timelines.Attends/participates in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting.Conducts local trial team meetings and provides or facilitates CRA training when needed (i.E. implementation of study amendment-and changes in study related processes)


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

Enfermera/O

Si buscas sentirte satisfecha/o con tu trabajo diario y afrontar nuevos retos profesionales, no dudes en inscribirte a nuestra oferta ¡Queremos conocerte! Ap...


Amavir - Madrid

Publicado 14 days ago

Enfermera/O Amavir Humanes

Si buscas sentirte satisfecha/o con tu trabajo diario y afrontar nuevos retos profesionales, no dudes en inscribirte a nuestra oferta ¡Queremos conocerte! Ap...


Amavir - Madrid

Publicado 14 days ago

Farmacéutico Adjunto (Barrio De Salamanca)

¿Te gusta la dermo, la nutri, las redes sociales y quieres trabajar en un entorno de trabajo variado y que ofrezca constante formación? Pues esta oferta es t...


Eurekafarma - Madrid

Publicado a month ago

Médico Neumólogo Pediatra - Madrid

En Dipla, Nuestra misión es el desarrollo profesional y personal del talento, con el objetivo de contar con los mejores profesionales para que las empresas y...


Dipla Partners - Madrid

Publicado a month ago

Built at: 2024-11-30T06:09:32.522Z