Location: Remote, India
Industry: Pharma/Healthcare/Clinical Research
End Date for Applications: 30th October 2024
About Us:
Thermo Fisher Scientific Inc. is the world leader in serving science, with a mission to enable our customers to make the world healthier, cleaner, and safer. With revenues of $13 billion, we employ approximately 39,000 people globally, serving customers in pharmaceutical and biotech companies, hospitals, clinical diagnostic labs, universities, research institutions, and government agencies. Our three premier brands—Thermo Scientific, Fisher Scientific, and Unity™ Lab Services—offer innovative technologies and streamlined solutions for laboratory operations.
Position Overview:
We are seeking a Clinical Trial Coordinator I to provide administrative and technical support within our clinical trial operations. This role is essential for ensuring audit readiness and facilitating efficient site activation processes for assigned projects.
Key Responsibilities:
- Conduct departmental, internal, country, and investigator file reviews as assigned, documenting findings in appropriate systems.
- Ensure timely completion of allocated tasks while maintaining quality standards and communicating any project risks to leads.
- Provide system support for tools such as Activate and eTMF, keeping databases up to date.
- Handle administrative tasks for assigned trials, including processing documents for the Client’s eTMF, performing reviews, and distributing communications.
- Assist in scheduling internal and client meetings as necessary.
- Track local regulatory documents and maintain vendor trackers.
- Support regulatory submissions for the start-up team.
- Collaborate with team members and clinical personnel to address site issues and risks.
Candidate Profile:
- Relevant formal academic/vocational qualification; a Bachelor’s degree is preferred.
- 6 months to 1 year of experience in a related role, providing the necessary knowledge and skills.
- Ability to work both independently and as part of a team.
- Flexibility to adapt to changing project timelines and priorities.
- Solid understanding of applicable country regulations, ICH Good Clinical Practices, and relevant SOPs.
- Proficiency in English and local languages, as necessary.
- Strong digital literacy, including proficiency in MS Office (Word, Excel, PowerPoint) and clinical trial database systems.
- Effective oral and written communication skills.
- Strong judgment and decision-making abilities.
- Attention to detail and the ability to follow project work instructions accurately.
Why Join Us?
Be part of a mission-driven organization that prioritizes innovation and quality in clinical research. At Thermo Fisher Scientific, you will contribute to meaningful projects that impact global health.
Application Instructions:
If you meet the qualifications and are interested in joining our team, please submit your resume and cover letter by 30th October 2024.