Clinical Study Manager

4 days ago


Bloemfontein, Orange Free State, South Africa Parexel Full time

Unlock Your Potential with Parexel

This is a hybrid position with travel 2/3 days a week to the sponsor's office in the region. As a member of our team, you will play a vital role in the success of our clients, including leading global biotechs and top 50 Pharma companies.

Our Clinical Operations Manager (Regulatory) is responsible for the performance and compliance with assigned protocols in a country, ensuring adherence to ICH/GCP and country regulations, client policies, quality standards, and adverse event reporting requirements.

Key Experience Required:

• Mandatory – Extensive experience in local EC and RA submission, including initial submission and protocol amendments submission.

• Experience in independently preparing submissions to both EC and RA.

• Skilled knowledge of the local regulatory environment, submissions, and approval processes.

• Experience in IMP supplies management at the local level and validation of translated documents.

At Parexel, we value our people and their passion, providing an open and friendly work environment where we empower individuals to develop their long-term careers. You will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments.

About Parexel

Parexel supports clinical studies across the full range of therapeutic areas, with longstanding partnerships with a vast client base. We have supported the trials of most top 50 best-selling drugs and enable more niche drug developments critical to patient well-being.



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