Sr Clinical Manager/ Lead and Sr CRA

Performs routine site visits, including pre-study, initiation, interim, and closeout visits.
Performs responsibilities with minimal support from management. Visits to include monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines and other applicable regulatory requirements and assurance of good site performance.
Performs necessary administrative functions (e.g., tracking of expense reports, time and attendance).
Manages the unblinded (pharmacy) part of investigational sites in blinded studies and performs routine site visits as unblinded pharmacy monitor, including reviews of randomization procedures, study drug accountability and reconciliation, accuracy, completeness and correct use of study drug related documentation, storage condition and expiry date of the drug.
Manages assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements.
Reports to project team, client, and site personnel any findings noted at monitoring visits. This is accomplished by completion of monitoring reports and follow-up letters within the project- specific timelines.
Maintains project tracking system of subject and site information.
Serves as back-up for Project Manager, Field Monitoring when required.
Provides training for colleagues on clinical, regulatory, administrative, and procedures.
Participates in feasibility studies and submission to IRBs.
Presents study materials at Investigator/study launch meetings when required.
Supports project management team with assessment of workload and site assignments within the project team.
Assists project management team with review of monitoring reports and study documents when required.
Performs feasibility activities, submission, SIV and monitoring in North Africa (Morroco and Argelia)
Performs necessary administrative functions (e.g., tracking of expense reports, time and attendance).

PROFESSIONAL MEMBERSHIPS

From 2005 to present

AMIFE Association of Medicine in Pharmaceutical Industry

Madrid, Spain

Attending @ASCO @sitcancer #ImmunoOnc2018?

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