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

• 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.