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Global Submission Specialist - Awards winning CRO

Employer
NonStop Consulting
Location
Braine-l'Alleud
Salary
Negotiable
Closing date
Apr 6, 2018

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Sector
Science, Life Sciences, Anatomy/Physiology
Contract Type
Employee
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional

Job Details

Global Clinical Trial - Submission Specialist

Department Title and Description
Global Clinical Trial - Submission

Planning, coordination, preparation and tracking of the documents needed for initial submission Start-up) and Substantial amendments (ongoing) of Clinical Study package for all countries (except US) in compliance with the Country Regulatory Requirements, EU clinical Trial directive, related Guidance, and company processes.

* Purpose/Objective of the job

Creation and collection of the submission documentation and compilation of the core dossier for an application to Competent Authorities (CAs) and/or Ethics Committees (ECs) to start, conduct and close a company-sponsored Interventional Phase I - Phase IV clinical study in any of the countries company or collaborative partners targets to conduct the study in, except the US.

Key Responsibilities and Major Duties

*Determine the appropriate submission strategy and consistency of the Clinical Trial Application (CTAp) across projects, studies and countries.
*Effectively Lead Clinical Trial Application Tracking Meetings for the preparation of the CTAp dossier during start-up with cross-functional team and assure timelines and dossier quality are managed according to expectations.
*Optimally compile and distribute the final Clinical Trial Application dossier (CTAp) and subsequent Substantial amendments to country applicants for submission to Ethics Committees and Competent Authorities.
*compliance with study timelines, company SOPs, local regulatory guidelines and regulations.
*Comply with the use and maintenance of the available planning & tracking tools (e.g. IRIS - HA submission and approval Tracking system) to generate reports and track the CTAp content and associated dates.
*Ensure Compliance with any revised Guidance & Regulations at EU and Country levels.


Experiences/ Knowledge Desired
* Experience in Clinical Trial Application preparation and coordination, regulatory or equivalent in the pharmaceutical industry.
* Experience in effective implementation of clinical plans/documents and document preparation.
* Experience in planning and coordination of study initiation.

* Knowledge equivalent to that attained with a Bachelor's degree in Life Sciences, Allied Health, Pharmacy, Nursing ,a Master's degree is preferable, and 2-4 years of clinically related or relevant experience.
* Thorough understanding of the drug development process and the impact of the European Clinical Trial Directive on company policies and procedures.

Sound like something for you or someone you know? Then get in touch with, Casper Skyum Hogh on +45 78 79 47 40 or email your CV in M.S Word format to C.hogh@nonstop-recruitment.com to find out more about this position, or any other that we might have available.

Company

Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries. 

Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery.  Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.

The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors. 

Company info
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