Study Start Up Specialist
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Hobson Prior are currently looking for a Study Start Up Specialist to join a leading biopharmaceutical research organisation who specialize in oncology product development and pioneering medicines that are used all over the world.
- Primary point of contact for study team on end-to-end start up activity.
- Partake in and/or lead Study-Start-up team meetings.
- Apply Study Start Up tools to track activities and develop reports.
- Oversee Feasibility activities including the negotiation and collection of Confidential Disclosure Agreements and the collection and analysis of Feasibility Questionnaires.
- Conduct site contract/budget negotiations.
- Collect essential documents from sites, tracking & review led by Document Management Team.
- Support the collection of country and site level intelligence.
- Complete, manage and/or support Ethics Committee and Regulatory Authority submissions.
- Complete, manage and/or support country and site-specific activities required to activate sites for a clinical trial as appropriate.
- Excellent oral and written communication skills.
- Proficient in Dutch, French and English
- Exceptional presentation, documentation, and interpersonal skills.
- Proficient in MS Office (Word, Excel, and PowerPoint), MS Project, email, and Internet.
- Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.
- Excellent planning and organizational skills with effective time management.
- Goal oriented, self-starter with proven ability to work independently.
- You will be comfortable with working with ambiguity, having the ability to act without having the total picture.
- Ability to proactively identify and solve problems.
- A minimum of 5 years' experience in site start-up and contract management in pharmaceutical company or in clinical research organization.
- Educated to a at least BA/BS degree level in Science or related field.
- Thorough knowledge of applicable regulations, drug development, and clinical trial management procedures.
- Detailed understanding of country level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel.
- Full understanding of clinical research principles and process.
- In-depth understanding of FDA and/or EU Directives and regulations, ICH Guidelines and country/local regulatory requirements (preferably in Belgium, the Netherlands and if possible also in France).
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.