Clinical Project Leader
Sanofi
Mumbai
7h ago

Purpose :

The Clinical Project Leader (CPL) -

  • 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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