Clinical Trial Administrator

7 days ago

Uxbridge, United Kingdom PE Global Full time

**PE Global is currently recruiting for a Clinical Trials Submission Associate for a leading multi-national Biotech client based in Uxbridge.**

***This will be an initial 12 month contract with strong possibility of extension.

The purpose of this role is to ensure technical compliance of our Clinical Trial submissions via the smooth compliant flow of information between all functional areas, local offices, external partners, and regulatory authorities.

**Role**:

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**:

Knowledge and execution of CTA Processes in EU
Comprehensive understanding of the EU Clinical Trials Regulation, EU Clinical Trials Directive and ICH/GCP
EMA Clinical Trial Information System (CTIS) experience preferred
Knowledge of the drug development processes, Regulatory Affairs and Submission Management is highly desirable
Veeva Vault RIM experience preferred
Microsoft Office Suites experience
Ability to quickly learn new software, regulations, and processes
Proactive, innovative problem solver and well-organized teammate
Degree educated with experience in pharmaceutical company

Please click the link below to apply, or alternatively send an up to date CV to

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