Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Are you ready to embark on a fulfilling career journey with Thermo Fisher Scientific Inc.? We are looking for a motivated and ambitious individual to join our PPD team as a Country Approval Specialist?. This outstanding opportunity allows you to contribute to world-class clinical trials, making a significant impact on global clinical research.
Responsibilities
- Prepares and performs the submissions to competent authorities including the ethics committees.
- Collect essential documents for the trial and sites assigned.
- Reviews, prepares the IP greenlight packages and works with the study team for the site activation readiness.
- Drive timely clinical trial site activations. Ensure all trial activations are flawless and comply strictly with regulatory standards.
- Collaborate with cross-functional teams. Work closely with research sites, regulatory, and clinical operations teams to successfully implement trial activation plans.
- Maintain comprehensive documentation. Keep meticulous records of all trial activation processes and approvals.
- Identify and address potential issues: Determine any barriers to trial activation and collaborate with teams to resolve them promptly
Requirements
- Educational background: Bachelor’s degree or equivalent experience in Life Sciences, Pharmacy, or a related field.
- Experience: Proven experience in clinical trial management, study startup activities or a related research role is preferred.
- Skills: Outstanding attention to detail, strong organizational skills, and the ability to work collaboratively in a fast-paced, dynamic environment, understanding of clinical trial requirements, regulation and GCP guidelines. .
- Communication: Excellent verbal and written communication skills to effectively interact with diverse teams, collaborators, and customers.
- Technical proficiency: Familiarity with clinical trial management systems and regulatory requirements.
Join us on our mission to enable our customers to make the world healthier, cleaner, and safer. Your expertise and dedication will contribute to our continued success and innovation in the scientific community.
What We Do
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Why Work With Us
You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.
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