Works closely with CPL Manager and is responsible for the set up and progress of a clinical trial/study within the country.
Is primarily responsible for the overall operational planning and activities for the implementation and conduct of studies at country level, and for performing oversight visits.
Ensures that the clinical trials are conducted in compliance with the company quality standards and the regulations in force, the forecasted timelines, milestones and budget.
Represents the country at the study team level and is the main contact for the Regional Trial Manager (RTM) / Global Study Manager (GSM)
He/ she ensures liaison with other study team members.
FOR CLINICAL STUDIES AND PROGRAMS:
Is accountable for set-up activities according to the company standards, regulations in force and country generic administrative timelines (submission to ECs/IRBs/HAs, approvals, contracts with sites, local AEDs), and that committed targets and timelines are met at all steps and until study completion (recruitment, active/inactive sites, deadlines for DMCs, DBL, closure of sites, archiving).
Participates in the assessment of the trial feasibility
Writes / validates the technical and/or administrative documents which are necessary for the trial and makes the corporate documents fit the local regulations, as necessary.
Organizes kick-off meeting with local monitoring teams (MTs).
Organizes training of monitoring teams (study procedures, study devices, monitoring plan, etc.).
Organizes investigators meetings.
Provides support to Monitoring Team (protocol, monitoring plan, CRF, tools…)
Prepares the local study AED and ensures optimization of costs.
Supports the submission dossiers for health authorities
Prepares the submission dossiers for ethics committees
Prepares the investigators’ contracts.
Ensures that site initiation visits are appropriately conducted.
Ensures the implementation of IT systems for the study (IVRS, e-Portal)
Ensures adequate provisioning of devices and materials for the study in advance
Participates in the revision/preparation of study progress tools (e.g. newsletters etc.)
Oversees field monitoring activities through regular contacts with local MTs (regional CTT), review of MVRs, checks on monitoring tool compliance, recruitment status etc.
Identifies potential risks and ensures action plans are in place (recruitment, study conduct/data quality, etc.).
Ensures high level of quality in data collection and queries resolution for the country.
Coordinates monitoring activities and reviews monitoring reports.
Provides appropriate responses to audit / inspection reports and implements recommendations in a timely manner.
Ensures that the local study files and eTMF are kept up-to-date by performing random QC of TMF documents.
Ensures appropriate site closure including archival of documents and return / destruction of IMP / NIMP.
Informs the investigators and the Health Authorities/ Ethical Committee of the trial’s results.
Ensures that the CTMS is updated with complete and accurate data on a timely manner.
Shares lessons learned and ensure adequate deployment of possible identified action plans for improvement within the study team.
Participates locally in the audits / inspections, coordinates and follows up the possible corrective and preventive actions.
Ensures an efficient liaison with IPM, MA, CSU-SL, CSU-QL, CSU-SE and other support team members.
Keeps a track of the payment of investigators fees.
Ensures regular updates to internal and external stakeholders (including National Coordinators and Investigators) in the form of monthly updates, newsletters or dashboards.
Tracks and ensures that the study KPIs are met, starting from the study allocation to the archival.
Works closely with the FLMs of FSP partners
Performs co-monitoring / quality control visits at investigational sites, as required.
CORPORATE TEAM / AFFILIATE MEDICAL AFFAIRS:
Makes sure that the CSO SCP / Trial Operations / Medical Affairs in the Affiliate / other relevant stakeholders receive all required data on the trial progress.
Participates in the meetings related to the trial and organized by the CSO SCP / Trial Operations / Study Team / Medical Affairs / Other relevant stakeholders
IN CASE OF OUTSOURCED STUDIES: (Depending on the Scope of Work)
Becomes the focal point of contact for the Clinical Research Organizations (CROs), internal and external stakeholders at the local, regional and corporate levels for all outsourced studies.
Ensures structured planning and execution of the clinical outsourced projects.
Performs periodic review of the projects so as to determine whether it is as per the plan and to take early actions, if any issues are identified.
Manages the budgeting process.
Ensures that the internal and external stake holders are periodically updated with the study progress.
Ensures that the vendors are trained on the company SOPs (if applicable).
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