Clinical Operations Specialist
1 month ago
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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