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Clinical Operations Manager (Regulatory) - UK - FSP - REGISTER YOUR INTEREST

Employer
Parexel
Location
United Kingdom
Salary
Competitive
Start date
11 Jun 2024
Closing date
11 Jul 2024

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Job Details

We are inviting applications to join our UK Clinical Operations Manager (Regulatory) talent pipeline. Please provide some basic information and upload your CV.

This will be a home-based position.

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. We have an incredible pipeline of work and a world of opportunity waiting for you.

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.

Experience required to be a fit for this role:

• Mandatory - 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.

We care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. In addition, you will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.

Who are Parexel?

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.

You’ll be an influential member of the wider team.

Not quite the role for you?

Join Our Talent Community and we’ll reach out with job alerts when positions that match your career interests become available. We’ll also share periodic updates about the latest company news and events.

Sign up today https://jobs.parexel.com/functional-service-provide

#LI-REMOTE

Company

parexel

When you join us, you’re joining a team that sees everything they do as an opportunity to transform the world for patients everywhere. When our employees bring their many perspectives together to tackle a new challenge, there’s no limit to what they can accomplish. Through it all, at the center of all we do, is a patient whose life could change – forever. And together, we’ll do it With Heart™.

How to describe Parexel’s culture in one word: 

Henry

 

 

Working With Heart™ - Christina's perspective:

Working With Heart™ - Christina's perspective:

 

Careers Blog | Our Culture | Diversity, Equity & Inclusion | Benefits | Our Hiring Process

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory, and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators, and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. 

Company info
Website
Telephone
+44 1895 238000
Location
The Quays
101-105 Oxford Road
Uxbridge
Middx
UB8 1LZ
GB

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