Senior Specialist – Clinical Operations

Smith+Nephew•Fort Worth, TX

2d•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. What will you be doing? 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 What will you need to be successful? 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 The anticipated base compensation range for this position is $96,500 - $167,500 USD annually (or hourly) 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. 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 candidate. In addition to base pay, we provide competitive bonus and benefits, which include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, parental leave, and generous PTO, paid company holidays annually and 8 hours of Volunteer time and a variety of wellness offerings such as EAP. You Unlimited. We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/). Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement Work/Life Balance: Flexible Personal/Vacation Time Off, 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 Training: Hands-On, Team-Customized, Mentorship Extra Perks: Discounts on fitness clubs, travel and more! #LI-HYBRID #LI-SB2 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. Stay connected by joining our Talent Community. 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 us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N. Explore our website and learn more about our mission, our team, and the opportunities we offer. Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Nephew a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude we work together to win. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited.

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

Experience with contract management systems and Microsoft Office, with eTMF and CTMS experience preferred

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