Hobson Prior are looking for a Study Start Up Specialist to join a biopharmaceutical research organisation who specialize in oncology product development and pioneering medicines that are used all over the world.

Job Responsibilities:

• Act as the primary point of contact to study team on end-to-end start up activity.
• Partake in or lead Study-Start-up team meetings as appropriate.
• Utilize 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 (Confidentiality Agreement and Clinical Trial Agreements).
• 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.
• Where required, complete, manage and/or support country and site-specific activities (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank committee approvals, etc.) required to activate sites for a clinical trial as appropriate.

Key Skills:

• Strong presentation, documentation, and interpersonal skills.
• Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.
• Strong oral and written communication skills.
• Excellent planning and organizational skills with effective time management.
• Excellent interpersonal skills.

Requirements:

• At least 5 years' experience in site start-up and contract management in pharmaceutical company or in clinical research organization.
• BA/BS degree in Science or related field.
• Thorough knowledge of applicable regulations, drug development, and clinical trial management procedures.
• Proficient in MS Office (Word, Excel, and PowerPoint), MS Project, email, and Internet.
• Proficient in Dutch, French and English
• Thorough understanding of country level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel.
• Thorough understanding of clinical research principles and process.
• Thorough 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).

Apply now:

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.