Clinical Operations Manager
1 month ago
Parexel is a leading global biopharmaceutical services company that supports clinical studies across various therapeutic areas. We have longstanding partnerships with a vast client base and have played a crucial role in the development of many top-selling drugs.
Job SummaryWe are seeking a highly experienced Clinical Operations Manager to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with ICH/GCP and country regulations, client policies, and quality standards.
Key Responsibilities- Prepare and submit local EC and RA submissions, including initial submissions and protocol amendments.
- Independently prepare submissions to both EC and RA, with support from the CTC team for document collection.
- Prepare ICF documents using templates.
- Manage IMP supplies at the local level, including vendors providing background medications and standard of care.
- Validate translated documents.
- Extensive experience in local EC and RA submission, including XML completion.
- Experience in independently preparing submissions to both EC and RA.
- Skilled knowledge of the local regulatory environment, submissions, and approval processes.
- Understanding of how regulatory requirements impact study start-ups.
We care about our people and offer a supportive and open work environment where we empower individuals to develop their long-term careers. You will have the opportunity to develop within your role, tackle further responsibilities, or develop your skill set within other related departments of Parexel.
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