Clinical Operations Specialist

1 month ago


Pune, Maharashtra, India CSS Fortrea Scientific Pvt Ltd Full time

As a leading global contract research organization, Fortrea Scientific Pvt Ltd offers a wide range of clinical development, patient access, and technology solutions across multiple therapeutic areas.

Job Summary:

  • Support the overall operations of clinical studies, including set-up, planning, and maintenance.
  • Collaborate with team members to provide high-quality services to clients.

Key Responsibilities:

  • Manage the set-up, planning, and maintenance of clinical studies in client portals.
  • Develop and maintain a comprehensive understanding of client conventions and database requirements.
  • Generate project-specific reports, ensuring accuracy and quality of metrics and data.
  • Support and train less experienced staff on clinical study operations.
  • Stay up-to-date on Standard Operating Procedures (SOPs), Work Instructions (WI), and regulatory guidelines.

Collaboration and Communication:

  • Participate in project teams and internal meetings to ensure effective communication and collaboration.
  • Prepare and coordinate ISR study files for archiving at project completion.
  • Ensure timely updates to customers on regulatory requirements, enrollment data, and safety information.

Customer Focus:

  • Regularly follow up with customer points of contact to track progress and address concerns.
  • Ensure contractual milestones are met and address any potential issues or delays.
  • Monitor eTMF compliance and provide guidance to investigator site staff as needed.

Fortrea Scientific Pvt Ltd is committed to delivering high-quality clinical development solutions that meet the evolving needs of our clients. We seek motivated professionals who share our passion for innovation and customer satisfaction.



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