Company: Docs Global (Continental Europe)
Reference: Ref AS-020448
Closing Date: 24 Feb 17
Salary (£): Competitive
Benefits: Excellent & Comprehensive
Because you are ready for the next step and you want to work for a global and succesful company. Do not hesitate to contact Carine Louckx at email@example.com
Roles & Responsibilities of the position
-Responsible for the independant preparation, review and approval of country related submission packages in accordance with ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards - within specific timelines and quality standards.
- Responsible for the independant preparation, review and approval of site level critical documents for Investigational Product release in accordance with regulatory/ sponsor requirements - within specific timelines and quility standards.
- Develop and finalize Master and Country Specific Information Sheets/ Informed Consent Forms
- Prepare and finalize Master and Country Specific EU Clinical Trial Application Forms and corresponding data files (EU only)
- Travel approx 15% domestic and/ or international. Anticipated activities may include attendance at Kick-off, investigator or study team meetings
- Perform feasibility, site identification, site contract negotiation etc.
- Prepare, review and submit submissions to CA, EC and other relvant authorities in order to obtain all necessary approvals pertaining to the clinical trial conduct
- Review and translate Drug Labels
- Experience of clinical study start up requirements and activities
- Excellent written and spoken in both Dutch and English
- Bachelor degree and/ or appropriate experience from the Medical/ science background and/ or discipline
- Good organizational skills and the abillity to manage multiple skills
- Customer service focused
- Attention to detail
- Solution focused
A challenging and dynamic role within a global operating company. Good salary and other conditions.
2 Globeside, Globeside Business Park
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