Clinical Operations Manager (Regulatory) – South Africa (Hybrid – Johannesburg) – FSP – REGISTER YOUR INTEREST Full Time

Description:

• We are inviting applications to join our South Africa Clinical Operations Manager (Regulatory) talent pipeline.
• This will be a hybrid position with travel 2/3 days a week to the sponsor’s office in the Johannesburg region.
• 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.
• 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.

Requirements:

• 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.

Benefits:

• Tremendous long-term job security and prospects.
• Opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.
• Open and friendly work environment.