JOB DESCRIPTION（Clinical Project Leader）
JOB PURPOSE: 1. Coordinates / supervises all the tasks generated by clinical trials and which were entrusted to him/her by the Head of CPLs 2. Ensures that these trials are carried out according to the required quality standard deadlines and to the CSU’s commitments. 3. Represents a privileged link between the corporate team and the CSU within the framework of these clinical trials.
KEY ACCOUNTABILITY: 1. For clinical trials Support the assessment of the trial feasibility if applicable Makes a selection of investigators Prepares the file submission to the Ethical Committee Prepares the investigators’ contracts. Prepares the clinical trial AED Writes / validates the technical and/or administrative documents which are necessary for the trial and makes the Corporate documents fit the local regulations. Organizes the local investigators meetings when appropriate. Ensures the good initiation of the centers, especially makes sure that the investigators are perfectly informed of the trial specificity and of its organisation. Ensures a good follow-up of the centers, i.e. By co-monitoring visits By assessing the monitoring reports By following the recruitment. Participates locally to the setting up of the audits carried out by the Corporate ; coordinates the answers and follows up the possible correcting actions. Ensures an efficient liaison with designated IP support . Checks the payment of the investigators fees. Ensures that tolerance items are collected and reported. Makes sure that centers are properly closed : Files archiving IP and trial material collection. Keeps informed the investigators and the Health Authorities/ Ethical Committee of the trial’s results. Ensures the update of CTMS. 2. Clinical Study Unit Trains the CRAs to the study’s specificity. Coordinates the activity of the CRAs working on the study (centers allocation, workload) Cares for the implementation of the study’s instructions. Ensures the setting up of the study’s file inside the CSU.
JOB-HOLDER ENTRY REQUIREMENTS:
Education: Minimum bachelor degree in clinical medicine or pharmacy
Experience & knowledge: At least 4 years previous experience in monitoring clinical trails is required
Core competencies: Good command of English ( written and spoken) Knowledge of PC (WORD, EXCEL, POWER POINT) Interpersonal communication skill Team player
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