Senior Project Coordinator (Spain)

Detalles de la oferta

.The Senior Project Coordinator works with Project Managers, Clinical Trial Managers, Site Selection Team and Clinical Research Associates (CRA) to provide administrative and coordinating support for site activation activities and other site level deliverables through all phases of the clinical trial lifecycle. As a Senior Project Coordinator, you will take the lead to ensure timeframes, targets and the quality of the deliverables are in line with internal and external customer expectations. As a Senior member of the team, you work autonomously to ensure optimized site activation and maintenance and you may be asked to mentor junior project coordinators.This role will be perfect for you if :You have a minimum of 2 years of experience as a Project Coordinator or equivalent position in clinical research and in the biotechnology, pharmaceutical, and/or CRO industry.You have proven Site Start-Up experience in the management of clinical trials and/or staff in a global/multi-regional environment.You have an interest in project administration and clinical research.You want to have an impact in a fast-growing company.More specifically, the Senior Project Coordinator:Prepare Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents.Establish site activation timelines with selected sites and coordinates activities to meet planned activation timelines.Communicate with clinical sites during site start-up.Collaborate with other functional departments to ensure alignment of activities to meet site activation targets.Escalate to the Project Manager risks to site activation schedule.Communicate directly with the study teams, external site staff, to ensure tasks and priorities are aligned to the defined study timelines.Collect, review and file sites essential documents.Ensure essential documentation is complete and of good quality to successfully first pass review for site activation.Ensure that the electronic Trial Master File (eTMF) contains the relevant regulatory documents for site activation and ongoing study management.Collect and distribute documents from/to sites.Produce meeting minutes from project meetings.Maintain ADI log.Assign documents for internal project-specific training and coordinate training reconciliation and documentation.May assist with drafting of study documents and study plans for clinical trials.Act as a main point of contact for all site correspondences for non-protocol related issues.Assist sites with local ethics submissions.Assist internal and external teams with access to study-specific systems.Assist with initiating and maintaining study files.Assist with assembling and shipping the Investigator's Study File.Maintain project timeline dates, enrolment tracking tools, and study material inventory.Prepare shipments of study supplies to clinical sites, when applicable.Assist with preparation of Investigators' Meeting.Distribute study correspondence to sites


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

Project Manager At Flir

Grooo are seeking an experienced Project Manager to join FLIRs Fixed Mount Solutions RD team. If you are passionate about technology, have a strong track rec...


Grooo Ab - Madrid

Publicado 8 days ago

Project Manager Concesiones (Sector Agua)

Gestagua (perteneciente al Grupo SAUR) se encarga de la gestión del Ciclo integral del Agua en su totalidad o en alguna de sus fases. Presente en España desd...


Saur Europe - Madrid

Publicado 8 days ago

Customer Success - Value Management Sr Advisor

We help the world run better At SAP, we enable you to bring out your best. Our company culture is focused on collaboration and a shared passion to help the w...


SAP - Madrid

Publicado 23 days ago

Project Manager

Working at The Adaptavist Group The Adaptavist Group is a global family of companies with a common goal. We combine the best of teamwork, technology, and pro...


Adaptavist - Madrid

Publicado 8 days ago

Built at: 2024-11-23T22:53:05.201Z