Thermo Fisher Scientific is a global leader in scientific services and research, committed to delivering solutions that address significant health challenges worldwide. The PPD clinical research team is dedicated to supporting a vast portfolio of clinical research, ensuring that innovative drugs reach the market effectively and efficiently.
Role Overview:
As a Trial Activation Approval Specialist I, you will play a vital role in preparing and conducting submissions to competent authorities, ensuring trials meet regulatory standards, and driving site activations within clinical trials. This position involves working closely with diverse teams to facilitate the smooth initiation of clinical studies and ensuring adherence to strict regulatory requirements.
Key Responsibilities:
- Regulatory Submissions: Prepare and submit documentation to relevant competent authorities and ethics committees.
- Document Collection: Gather essential trial and site documents.
- Site Activation Readiness: Review and prepare IP greenlight packages, collaborating with study teams to ensure site readiness.
- Site Activations: Drive timely activation of clinical trial sites while maintaining compliance with regulatory standards.
- Collaboration: Work closely with cross-functional teams, including research sites, regulatory bodies, and clinical operations.
- Documentation: Maintain comprehensive and meticulous records of trial activation processes and approvals.
- Issue Resolution: Identify potential trial activation barriers and collaborate to address them effectively.
Qualifications:
- Education: Bachelor’s degree or equivalent in Life Sciences, Pharmacy, or a related field.
- Experience: Prior experience in clinical trial management, study startup, or a related research role preferred.
- Skills:
- Attention to detail and strong organizational capabilities.
- Ability to work collaboratively in a fast-paced and dynamic environment.
- Understanding of clinical trial requirements, regulations, and GCP guidelines.
- Communication: Strong verbal and written communication skills for effective team interaction.
- Technical Proficiency: Familiarity with clinical trial management systems and relevant regulatory requirements.
