Experience more than 10 years in Global studies involves more than 10 countries (more than 3 sites in each country) from feasibility to close out activities.
Overall responsable for the development of global clinical studies and participate in developing all study documents (protocols, CRF electronic, ICF, investigators and monitoring guidelines...)
Coordinate of crossing project international team
Collecting information on team performance against contract, customer expectation and project baselines.
Participate in kick of meeting with sponsor
Prepare and presentation in Investigator meeting
Coordinate feasibility activities including site selection and evaluation, follow up of clinical site management and monitoring
activities throughout monitoring visits, drug supply management and review of clinical data with clinical teams and ensuring
compliance with regulatory, quality and study requirements.
Update and write a Monitoring Plan of project
Review of Monitoring reports
Act as the main contact with vendors to supervise, track and ensure proper shipment/distribution of clinical and no clinical support such as study drug, laboratory samples and materials, ECG materials, and eCRFs data.
Prepare weekly and monthly project status reports for the Sponsor
Provide support and training to other team members
Assist CRAs with monitoring issues
Act as a secondary contact with the Sponsor
Training and mentoring of junior project support staff
Development and overseeing of project databases and project plans
Clinical Trials Consultant
Calle del Rollo, 10, 1
28005 Madrid SPAIN
Calle Juan Florez 64
15004 A Coruña SPAIN
6, Rue Bonaparte
75006 Paris FRANCE
Teléfono: +34 697485884
Correo electrónico: firstname.lastname@example.org
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