Regulatory Submissions (Study Start-up) Manager

CK Group
EU50000 to EU60000 per annum
23 Sep 2020
21 Oct 2020
Amy Lloyd
Contract Type
Full Time
CK Clinical are recruiting for a Regulatory Submissions (Study Start-up) Manager on a permanent basis.

This role is based in Belgium-Leuven.

The Company:
A full-service clinical contract research organization (CRO) who provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Their mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. They leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.

Regulatory Submissions (Study Start-up) Manager Role:

- Efficiently manage and successfully execute all aspects of global start-up.
- Perform quality checks on submission documents and site essential documents.
- Prepare and approve informed consent forms.
- Review pertinent regulations to develop proactive solutions to start-up issues and challenges.
- Present during bid defences, general capabilities meetings, and audits.

Your Background:

- At least 4 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience.
- Knowledge and experience of Clinical Trial Applications within Europe.
- Strong oral and written communication skills.
- Team oriented approach and strong leadership skills.
- Fluency in English.

For more information or to apply for this Regulatory Submissions (Study Start-up) Manager position, please contact CK Group, quoting job ref 48923.

It is essential that applicants hold entitlement to work in the country where the services will be delivered.

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