Working at Parexel offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. We have an incredible pipeline of work and a world of opportunity waiting for you.
The Clinical Operations Manager (Regulatory) is accountable for performance and compliance with assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards, and adverse event reporting requirements internally and externally.
Experience required to be a fit for this role:
· Mandatory Extensive experience in local EC and RA submission (must be familiar with XML completion) including initial submission and protocol amendments submission.
· Experience in Independently preparing submissions (CTC supports with documents collection) to both EC and RA.
· Experience in ICF preparation using templates.
· Skilled knowledge of the local regulatory environment, submissions, and approval processes, and understanding of how these impact study start-ups.
· Experience in IMP supplies management at the local level (vendors providing background meds, the standard of care, etc.)
· Experience in validation of translated documents.
We care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. In addition, you will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.
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