Hobson Prior are currently recruiting for a Senior Regulatory Site Start Up Specialist to join a global medical devices company who are committed to transform people's lives through new medical solutions that can improve the health of patients worldwide. This role can be based in any of the following locations: Germany, France, Italy, Belgium, Spain, or the UK.

Please note that to be considered for this role you must have the right to work in these locations.

Job Responsibilities:

• Work self-sufficiently and proactively to coordinate all necessary activities for site regulatory submissions and essential document collection for allocated clinical research sites.
• Manage multiple sets of essential regulatory documents across several studies and division portfolios.
• To partner with clinical sites to support the negotiation and customization of Informed Consent Form.
• Develop and foster clinical research site relationships to become a subject matter expert in the site start up regulatory process across multiple studies.
• Leverage knowledge of site regulatory processes and division priorities to meet clinical study goals and objectives.
• Manage to achieve target IRB/EC timelines by assisting clinical research sites with the application submission process and approval tracking.
• Manage and problem solve site start up challenges that arise to mitigate impact to service level agreement and study goals.
• Develop, prepare, complete and track required regulatory, ICF and legal documentation.
• Document clinical research site and investigator readiness for participation across multiple studies.
• Support internal quality audits, regulatory inspections, as applicable.
• Update and maintain study-specific start-up trackers.
• Any other assigned duties.

Key Skills:

• Ability to multi-task: support several studies and/or personnel simultaneously, work in a very fast paced environment.
• Ability to work in a team environment and possess clear, concise communication & presentation skills - written and verbal.
• Must be comfortable interacting with clinical research site personnel via phone, email, and in person.
• Demonstrated ability to establish credibility internally and externally by commanding knowledge of informed consent requirements.

Requirements:

• Bachelor's Degree, or an equivalent combination of experience and education.
• At least 4+ years' experience in clinical/scientific research and medical device experience, specifically clinical study site start-up experience within assigned geographies.
• Previous experience working with investigational review boards.
• Previous experience working with clinical trial management systems (e.g. Siebel CTMS, Veeva) and clinical document control systems / eTMF.

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.