Clinical Operations Manger (FSP) - Regulatory

PAREXEL FSP is currently looking for an experienced Regulatory & Submissions Manager (known internally as Clinical Operations Manager – Regulatory) to join our expanding team in Netherlands!

Home-based.

Play a pivotal role in some of the most significant clinical studies taking place today!

Single sponsor dedicated to a legendary pharmaceutical R&D powerhouse. A top 10 company and the name behind an incredible array of medicines, therapies, and vaccines. Collaborate, and learn, alongside some of the industry’s most experienced people.

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.

Working as a COM-R at Parexel FSP provides an exciting platform for your skills, as well as the potential to develop into a variety of career paths. We make a difference in millions of lives. We’ll do the same for your career!

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.

About Parexel FSP

For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.

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.