Supervise and guarantee the proper execution and follow the clinical trials under their responsibility delegated to CROs, in the established time and quality.
Responsibilities: Manage the clinical trial plan under their responsibility, communicating any deviation on times to the Medical Director and participating in the elaboration of contingency plans and the implementation of corrective measures for the required adjustments.
Participate in the selection of CROs and external vendors required in the CT and control the execution of all contracted activities ensuring that the various activities are conducted in accordance with the plans (cost, quality and time).
Participate with potential partners of the study and the Medical Director in identifying the centers and researchers involved in the study, and identify the criteria to ensure the performance of the trial in each center.
Review all the necessary documentation of the participating centers to obtain approvals from CEICs and Health Authorities where the study will be conducted.
Create the monitoring plan of the study and maintain it updated.
Review and approve all materials and guidelines required for the clinical trial.
Supervise the control of blood samples for pharmacokinetic and/or pharmacodynamics studies, guaranteeing their shipment within the indicated times for analysis and storage in the central laboratory.
Inform researchers on all relevant aspects of clinical trials and ensure their continuous updating.
Supervise the quality of the centers participating in the monitored studies applicable to their clinical trial.
Participate in the formation of potential Independent Committees (IDMC, IRC, etc.)
involved in the clinical trial, coordinate their activities and maintain archive and traceability of all generated documentation necessary for dossier purposes.
Coordinate and prepare the necessary materials for initial visits to the centers under their supervision.
Elaborate amendment documents to the protocols of the clinical trial under their responsibility and coordinate the approval of these amendments, ensuring that new versions of the protocols are edited if applicable.
Qualifications: Education: Degree in Health Sciences Master is a plus.
Languages: Fluent Spanish and English, knowledge of other languages will be an asset.
Experience (years/area): +4 years of experience in a similar position, in charge of international clinical trials.
Specific Knowledge: Knowledge of applicable law in international clinical trials is a must.
Travels: Willingness to travel.
Personal skills: Strong organizational and prioritization skills, detail oriented, ability to perform database/literature searches; excellent interpersonal skills and effectively in a team environment; clear, effective written and verbal communication skills; ability to work under pressure in order to meet tight deadlines; client focused approach to work.
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