Study Site Management Specialist

Study Site Management Specialist

Physical well-being is more than just body; it includes our minds and emotions. Smith and Nephew develops technology to break health barriers, empowering people from farmworkers to grandparents to accept limitless possibilities. Our purpose: Life Unlimited.

This role will be involved in managing the day-to-day execution of S+N sponsored studies via execution of site and regional vendor activities. Function as a regional/site liaison working with cross-functional study teams.

What will you be doing?

• Developing SME responsible, with guidance, for the coordination of all site
  management activities from selection, preparation, activation, enrollment, follow-up, and closure in small projects or portions of large projects.
• Ensure successful execution of studies at the site level via strong collaboration with study teams including but not limited to Clinical Study Management, Data Management, Clinical Research Associates, Clinical Trial Associates and applicable vendors.
• Represents S+N as the primary point of contact for study sites, applicable vendors, and Clinical Trial Associates. Responsible for development and maintenance of these professional relationships.
• Development of regional study documentation such as protocols/addendums, ICFs, and local ethics/regulatory documents.
• With support, conduct regional vendor qualifications and maintain vendor oversight.
• Ensure site quality via site training, site visits if applicable, compliance reviews, trending, corrective actions, and escalation.
• Utilise study management systems to create and maintain oversight of site
  documentation, data entry/integrity, monitoring, statuses, milestones, issues,
  systems access, etc.
• Support Clinical Study Management with applicable budget planning, budget
  accruals and payments.
• Ensure study related activities are carried out in accordance with the appropriate regional regulations and GCP guidelines. This will usually be ICH GCP for medicines and ISO 14155 for Medical Devices, within the ISO9001 quality system, and any other applicable regional Regulatory/GCP guidelines.
• Developing knowledge of applicable business units.
• Represent Global Clinical Research Operations at relevant cross functional project meeting(s), where appropriate.
• Liaise with local product teams/stakeholders and in country sales and marketing personnel, where appropriate

What will you need to be successful?

• Bachelor of Science or greater; qualification and experience in engineering, design, scientific, clinical subject or related field (e.g., life sciences, nursing, pharmacy.
• License/Certification: GCP
• 3 years of relevant industry experience would be preferred.

To apply, please ensure that you include a cover letter addressing it to Talent Acquisition Lead ANZ. Due to a high volume of applications, please note that only shortlisted candidates will be contacted.

You. Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people, the patients we serve, and to the wider health of the planet and society.

• Inclusion + Belonging - Committed to Welcoming, Celebrating and Thriving. Learn more about our Employee Inclusion Groups on our website https://www.smith-nephew.com/ 
• Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day    
• Flexibility: Hybrid Work Model (For most professional roles)    
• Training: Hands-On, Team-Customized, Mentorship    

We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day.    Check our Glassdoor page for a glimpse behind the scenes and a sneak peek into YouUnlimited, life, culture, and benefits at S+N.     

Explore our new website and learn more about our mission, our team, and the opportunities we offer.    

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