Clinical Operations Manager Regulatory - Hybrid - Czechia - FSP

At Parexel FSP people make the difference. We have a crucial mission: to prevent and cure disease by delivering important new medicines and therapies to patients in need. We achieve this important goal through the knowledge, expertise, innovation, and commitment of our employees around the world.

Our employees have the opportunity to do meaningful things globally while we support them locally in environments full of challenge, collaboration, flexibility and industry-leading growth potential.

Parexel FSP is looking for a Clinical Operations ManagerRegulatory in Czechia, hybrid, office based in Prague.

You will be 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.

We will offer you exceptional financial rewards, training, and development. Expect exciting career challenges, but with a healthy work-life balance. We value your well-being as much as that of our patients.

Experience required to be a fit for this role:

· Mandatory – at least 1-year experience in Czechia 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.

Desirable:

· Experience with country and site budget including development, negotiation, and completion of Clinical Trial Research Agreements and oversight and tracking of clinical research‐related payments and Payment reconciliation at study close‐out.

For more details contact marta.kuniewicz@parexel.com