Country Start Up Specialist - Office Based
ProClinical is working with a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Their clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and approximately 20,000 professionals worldwide.
This leading CRO is recruiting a Clinical Submissions Specialist to join their Start-Up/Site Intelligence & Activation (SIA) department in The Netherlands. The Submissions Specialist will manage the preparation, review and coordination of local Ethics Committee and Competent Authority/Regulatory submissions in The Netherlands and will coordinate all activities to get investigation sites ready to enroll patients in their clinical trials.
- Preparation, reviewing and coordinating local ethics committee and regulatory submissions in alignment with global submission strategy
- Providing local regulatory strategy and advice
- Acting as a key contact on a country level for all submission related activities and provide oversight for projects
- Taking ownership of bringing qualified sites to the status of 'ready to enrol'
- Contacts sites to resolve issues and determines completeness and readiness of site for IP Approval.
- Maintain knowledge of and understand company SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided
- Ensures the study files and filing processes are followed for the documents sent to file as per company WPDs or applicable client SOPs.
- Additional tasks in line with business and department need
Skills and Requirements:
- Bachelor's degree in a life science subject
- Regulatory and submission experience and a good knowledge of applicable local requirements. We would also accept applications from CRAs with submissions experience.
- Basic medical/therapeutic area and medical terminology knowledge
- Excellent communication and organisational skills and a self-motivated, flexible and professional attitude. The ability to handle multiple tasks effectively, often within strict deadlines is essential.
- Dutch and English language skills
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Theodora Savlovschi-Wicks on +44 203 7520 314 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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