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Are you ready to kick-start your career in clinical research with a global healthcare leader? Do you have a passion for ensuring clinical trials run smoothly from the very beginning? Would you like to grow in an innovative environment where your contributions truly matter?
If you answered yes, apply now for the Junior Clinical Start Up Specialist position at our company!
The Position
As our Junior Clinical Start-Up Specialist you will play a vital role in clinical research. You will manage start-up activities for clinical trials, ensuring compliance with local regulations, good clinical practice, our company procedures, and protocol requirements. Your work will focus on delivering reliable data and protecting study participants as you activate trial sites before the first patient visit in the country. Additionally, you will be responsible for executing regulatory submissions, including clinical trial applications, and ensuring timely approvals.
In addition, you will:
Prepare and submit Clinical Trial Applications to Health Authorities and Ethics Committees, ensuring compliance with local regulations, trial protocols, and applicable guidelines
Follow up on submissions until approvals are obtained, and collaborate with teams to answer queries and provide necessary documentation
Maintain effective communication with Health Authorities and Ethics Committees, ensuring all trial team members are informed of submission status and timelines
Manage document translations and approvals, including Clinical Trial product labels and directions for use
Ensure timely updates in the Vault Regulatory Information Management system, maintain confidentiality, and comply with company policies and regulatory requirements.