Clinical Trial Specialist with Regulatory Expertise

3 weeks ago


Mumbai, Maharashtra, India Lifelancer Full time

Company Overview

Lifelancer is a leading talent-hiring platform in Life Sciences, Pharma, and IT. We connect talented professionals with opportunities across pharma, biotech, health sciences, healthtech, and IT domains.

Salary

The estimated annual salary for this role is $65,000 - $85,000, depending on qualifications and experience.

Job Description

We are seeking a skilled Clinical Trial Specialist to join our team. As a Clinical Trial Specialist, you will be responsible for developing awareness of regulatory legislation, guidance, and practice in assigned regions/countries. You will work closely with senior staff to complete activities for clinical trial applications performed according to European Clinical Trials Regulation No 536/2014 in the Clinical Trials Information System (CTIS).

  • Complete Part I application information in Clinical Trial Information System (CTIS)
  • Accurately upload all Part I and Part II documents to CTIS
  • Initiate the payment process for Part I and/or Part II submission fees and seek approval from Global Regulatory Submissions Lead (GRSL) colleagues
  • Monitor CTIS and promptly inform GRSL of all received alerts in CTIS
  • Ensure timely tracking of all submissions and approvals (decisions) in applicable tracking tools
  • Upload the final submitted package to the Trial Master File and perform functional reviews as applicable
  • Perform a review of final submission documents as applicable and specifically perform QC of Part II applications (as delegated)
  • Submit application/notifications in CTIS upon permission of GRSL
  • Ensure high-quality documents are uploaded and filed and systems are updated on an ongoing and timely basis making Fortrea ready for an audit at any time
  • Escalate study issues appropriately and in a timely fashion
  • Attend team and company meetings as applicable
  • Perform other duties as assigned by management depending upon country and situational requirements with proper supervision (if applicable)

Required Skills and Qualifications

To be successful in this role, you should have:

  • Strong knowledge of regulatory legislation, guidance, and practice in assigned regions/countries
  • Excellent communication and organizational skills
  • Ability to work independently and collaboratively as part of a team
  • Strong attention to detail and ability to ensure high-quality work
  • Proficiency in using Clinical Trials Information System (CTIS)

Benefits

Lifelancer offers a competitive compensation package, including:

  • An estimated annual salary of $65,000 - $85,000
  • Opportunities for professional growth and development
  • A collaborative and dynamic work environment
  • A comprehensive benefits package


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