Spec I PSS

2 weeks ago


Mumbai, Maharashtra, India Fortrea Full time

As a prominent global contract research organization (CRO) with a strong focus on scientific excellence and extensive experience in clinical development, Fortrea offers pharmaceutical, biotechnology, and medical device clients a diverse array of clinical development, patient access, and technology solutions spanning over 20 therapeutic areas. With a workforce of over 19,000 employees operating in 90+ countries, Fortrea is revolutionizing the landscape of drug and device development for partners and patients worldwide.

Roles & Responsibilities:

  • Ensure IST investigator provides study updates to customers including regulatory updates, enrollment data, safety information, and notifies of any protocol or informed consent amendments
  • Conduct process trainings within the team and provide refresher trainings as needed
  • Assist in preparing dashboards at regular intervals under the guidance of team leads
  • Monitor and ensure compliance with contractual milestones, escalating any risks or missed milestones to the customer
  • Monitor eTMF compliance as per the filing plan, providing guidance to Investigator site staff via queries in the BMS FastTrack communication portal
  • Validate initial drug supply demand based on Investigators enrollment plan and offer forecasting updates to BMS
  • Review Country/Site Informed Consent Form for compliance with sponsor and regulatory requirements, as well as Good Clinical Practice (GCP) guidelines
  • Review protocol and amendments to ensure adherence to sponsor requirements and GCP guidelines
  • Support in preparing presentations for customer governance calls

Fortrea actively seeks dynamic problem-solvers and innovative individuals who resonate with our mission to overcome obstacles in clinical trials. Our dedicated focus is on transforming the development process to facilitate the prompt delivery of groundbreaking ideas and treatments to patients in need. Become part of our exceptional team and engage in a collaborative environment that fosters personal development, empowering you to create a significant global impact.


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