Specialist - Study Site Management (US Field)

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.

The Clinical Research professional responsible, with guidance, for the day-to-day execution of S+N sponsored studies via execution of site and regional vendor activities. Functions as a regional/site liaison working with cross-functional study teams ensuring adherence to Good Clinical Practice (GCP), applicable regulations, standard operating procedures, S+N Code of Conduct, and study protocols in accordance with established budgets and timelines.

What will you be doing?

• Local developing SME responsible, with guidance, for the coordination of all site management activities from selection to 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 regional vendors.
• Represents S+N as the primary point of contact for study sites, regional vendors, and Clinical Research Associates. Responsible for development and maintenance of these professional relationships.
• Development of regional study documentation such as protocols, ICFs, and local regulatory documents.
• Ensure site quality via site training, site visits if applicable, compliance reviews, trending, corrective actions, and escalation.
• Utilize study management systems to create and maintain oversight of site level data integrity, statuses, milestones, issues, systems access, etc.
• Support Clinical Study Management with applicable budget planning, budget accruals and payments.

What will you need to be successful?

• Education: Bachelor of Science plus 2 years' experience or Master of Science plus 1 year experience; qualification and experience in scientific, clinical subject or related field (e.g., clinical research coordinator, clinical trial or research associate); GCP certification is preferred.

• Experience:
  • Negotiation and professional relationship/communication skills; strong oral and written English.
  • Proficiency in processes - demonstrates understanding and quality delivery of regional milestones according to established timelines.
  • General understanding of customer and business needs within assigned area.
  • Ability to handle moderate projects/problems and resolve a variety of issues via utilization of company procedures and guidance of more senior members of the team.
  • Developing knowledge of local regulatory requirements and ICH-GCP
• Travel Requirements: up to 25% travel - domestic and international

The anticipated compensation range for this position is $63,750.00 - $85,000.00 USD annually. The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, geographical location, and internal equity. It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew. Compensation decisions are dependent upon the facts and circumstances of each position and candidates.

You. Unlimited

We believe in creating thegreatest good for society. Our strongest investmentsare in our people and thepatients we serve.

Inclusion, Diversity and Equity- We are committed to welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/ ).

Other reasons why you will love it here!

• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
  Work/Life Balance: PTO, Paid Holidays, Flex Holidays, Paid Community Service Day
• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
• Flexibility: Hybrid Work Model (For most professional roles)
• Training: Hands-On, Team-Customized, Mentorship
• Extra Perks: Discounts on fitness clubs, travel and more

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Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.