Senior Specialist – Clinical Operations

Smith & NephewFort Worth, MA
Hybrid

About The Position

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Are you driven by the opportunity to shape the success of global clinical trials? Join us as a Senior Specialist Clinical Operations and play a critical role in leading clinical trial contracting and budget negotiations that directly support the development of innovative medical technologies. This role offers the chance to work cross functionally, influence strategy, and make a meaningful impact on patients’ lives worldwide.

Requirements

  • A Bachelors degree in Life Sciences, Business, Finance or a related field, with a Masters degree preferred
  • 5 to 7 or more years of experience in clinical research contracting, budget negotiation or clinical operations finance
  • Strong expertise in negotiating clinical trial agreements and site budgets for industry sponsored studies
  • Solid knowledge of ICH GCP, FDA, EMA and global clinical research compliance requirements
  • Excellent analytical, financial and problem solving skills with strong attention to detail
  • Clear and confident communication skills with the ability to influence stakeholders at all levels
  • Experience with contract management systems and Microsoft Office, with eTMF and CTMS experience preferred

Nice To Haves

  • Masters degree

Responsibilities

  • Leading and executing complex clinical trial contracts and budget negotiations with investigative sites, CROs and vendors
  • Partnering with Clinical Operations leadership to develop and deliver contracting and budgeting strategies across programs and portfolios
  • Providing strategic input into study feasibility, start up planning and early budget development
  • Ensuring contracts and budgets comply with company policies, regulatory standards and regional requirements
  • Collaborating closely with Clinical Operations, Finance, Legal and study teams to drive timely execution and approvals
  • Identifying financial, operational and regional risks and proactively proposing mitigation strategies
  • Tracking contract and budget performance, reporting trends and key metrics
  • Driving continuous improvement initiatives to enhance efficiency, consistency and best practices
  • Acting as a subject matter expert on contract templates, budget models and industry standards

Benefits

  • 401k Matching Program
  • 401k Plus Program
  • Discounted Stock Options
  • Tuition Reimbursement
  • Flexible Personal/Vacation Time Off
  • Paid Holidays
  • Flex Holidays
  • Paid Community Service Day
  • Medical, Dental, Vision
  • Health Savings Account (Employer Contribution of $500+ annually)
  • Employee Assistance Program
  • Parental Leave
  • Fertility and Adoption Assistance Program
  • Discounts on fitness clubs, travel and more!
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