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RD-Clinical Project Leader China,  

Sanofi (company)


Posted on : 08 August 2019

Project Description

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 

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Locations

Shanghai|Guangzhou|Beijing, - Multiple Locations

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