Clinical Operations Manager, Regulatory (FSP) - Netherlands

PAREXEL FSP is currently looking for an experienced Regulatory & Submissions Manager to join our expanding team in Netherlands.

Currently, the position is home-based.

The Clinical Operations Manager (COM-R) 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 – at least 1-year experience in Netherlands EC and RA submissions (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.

• Oversight and tracking of clinical research‐related payments and payment reconciliation at study close‐out.

We offer exceptional financial rewards, training, and development. Expect exciting professional challenges but with a healthy work/life balance. We value your welfare just as highly as that of our patients.