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