Browse by job sector

EU Clinical Trial Submission Associate

  1. Remote
Remote work
  1. Contract
Competitive
  1. CAPEX Projects
09-09-2024
32956
Apply to this job Save job
EU Clinical Trial Submission Associate - Remote, UK - 12-Months 

Our client, a globally recognised pioneer in Biotechnology, are recruiting for the position of Clinical Trial Submission Associate. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to join them on their global mission to better the lives of those effected by disease and illness.


Responsibilities include:
  • You will be assigned to one or more products under development to ensure Clinical Trial Application approvals in the EU. As technical experts in the EMA Clinical Trial Information System (CTIS), ensure compliance with EU Clinical Trials Regulation for every Clinical Trial submission dossier through close internal cross-functional collaboration.
  • Coordinate for Clinical Trial Submissions and Notifications in the state-of-the-art Regulatory Document Management System and maintain tracking systems.
  • Be the critical technical coordinator for Clinical Trial Submissions and Notifications through the EMA Clinical Trial Information System (CTIS), ensuring accurate and timely input of data into the EMA CTIS system for Clinical Trial Applications, Modifications and Notifications.
  • Be responsible for reviewing and triaging of Requests for Information from Health Authorities through CTIS to relevant cross functional teams.
  • Support the EU Regulatory Lead to prepare Submission Content Plans and documentation for regulatory deliverables, for the management of Clinical Trials.
  • Assist with definition, development, and implementation of processes to meet the evolving CTIS needs.
  • Raise, inform, and resolve any issues that may impact submission process or timelines within CTIS.

Requirements
  • The role is focused on the submissions for the UCTR, EU region only, and it is done through a system which is called CTIS (Clinical Trails Information System). We must have candidates with experience using this system. Would want to understand how many countries were included in the submissions that you have performed in the past. 
  • Knowledge of regulation and the system, for example, what kind of activities have you performed so far? Including different kind of submissions such as initial application, additional member states, notifications, not substantial modification, and transitional applications. How many are done monthly and to see how widely you are engaged in these kind of activities.
  • You must have experience on systems, essential to have CTIS experience or at least some experience with it, for example, six-months.
  • Viva Volt - What is your knowledge on Viva Volt (RIM)? 
  • EU clinical trial understanding – do you know how CTR works?  Content base knowledge of the process is great to have too.
  • Previous experience in: Reg team admin / administrative assistant / clinical reg admin

If this role is of interest, please apply now.


 #LI-KT1
Apply to this job Save job
Save as a job alert
List #1

Similar Jobs

Construction Manager

Salary

Competitive

Location

Brussels

Salary

up to £35,000

Sector

CAPEX Projects

Job type

Contract

Location

Brussels

Description

Construction Manager - Pharmaceuticals - 12-Month Contract  We are looking for an experienced Construction Manager for a fantastic 11 month contract based in Brussels. You will be working with

Reference

35004

Expiry Date

01/01/0001

Chris Bland

Author

Chris Bland
Chris Bland

Author

Chris Bland
Read more
Read more
Project Engineer

Salary

Competitive

Location

Central London

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

London

Description

Project Engineer - Pharmaceuticals - 12-Month Contract  We are working with a new UK based pharmaceutical client who specialise in developing and producing CBD products across range of

Reference

34850

Expiry Date

01/01/0001

Elli Buckland

Author

Elli Buckland
Elli Buckland

Author

Elli Buckland
Read more
Read more
Quantity Surveyor

Salary

Competitive

Location

Frankfurt ( Oder)

Salary

Competitive

Sector

CAPEX Projects

Job type

Permanent

Location

Frankfurt

Description

Quantity Surveyor - Frankfurt - 12-Month Contract  Are you a Quantity Surveyor looking for your next contract role? We have a fantastic opportunity for you to join our valued client in Frankfurt

Reference

35008

Expiry Date

01/01/0001

Becky Daly

Author

Becky Daly
Becky Daly

Author

Becky Daly
Read more
Read more

Insights

life sciences testing laboratory

Why you should work in Commissioning, Qualification and Validation
Read more

02/07/2023

Your next step as a Validation Engineer
Read more

07/20/2021

pharmaceutical factory construction

Working in an organisation from Start Up Phase

Read more

06/28/2021

VIEW ALL

Send us your CV

Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.

Send your CV
Upload your CV