CLINICAL PROJECT LEAD/ PROJECT MANAGER

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

Contact

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: info@clinical-trials-consultant.com

 

Clinical Trials Link

For publications or to search for a potential investigator’s publication history –

www.pubmed.org



For information about European oncology centres:

• European Network for Cancer Registries – www.encr.com.fr

For clinical trials information (Clinical Trials NIH) - www.clinicaltrials.gov

For a general guide to internet resources for cancer – www.cancerindex.org

Clinical Trials Consultant will be attending conferences in 2018 and very much hope to meet you there.

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