HomeClinical TrialsClinical Project Leader | Sanofi Healthcare | Mumbai

Clinical Project Leader | Sanofi Healthcare | Mumbai


Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain, and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

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With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

“Sanofi, Empowering Life”

Position: Clinical Project Leader

Location: Mumbai, Maharashtra, India

Job Description:

For Clinical Studies & 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 meetings with local monitoring teams (MTs)., training of monitoring teams (study procedures, study devices, monitoring plan, etc.), and investigator meetings.
  • Provides support to MTs (protocol, monitoring plan, CRF, tools…)
  • Prepares the local study AED and ensures the optimization of costs.
  • Supports the submission dossiers for health authorities and 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 (e.g. laptops etc.).
  • 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 a 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.
  • Ensures that the CTMS is updated with complete and accurate data in 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.
  • Tracks and ensures that the study KPIs are met, starting from the study allocation to the archival.

Qualification: Appropriately Qualified & Experience to Execute above JD

Salary: Negotiable

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