Lead - Clinical Study Management

Smith & Nephew Plc

JOB DETAILS
SALARY
$123,500–$184,775 Per Year
SKILLS
Budget Management, Clinical Research, Clinical Trial, Communication Skills, Corrective Action, Cross-Functional, Data Quality, English Language, GCP (Good Clinical Practices), ICH Regulations, ISO (International Organization for Standardization), Leadership, Maintain Compliance, Project/Program Management, Quality Monitoring, Regulatory Requirements, Startup, Vendor/Supplier Management, Work From Home
POSTED
30+ days ago

Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Join us as a Lead - Clinical Study Management and play a pivotal role in shaping the future of clinical research. This is your opportunity to lead complex, global studies that make a real difference to patients' lives-all while working remotely from anywhere in the US or Canada.

What will you be doing?

• Lead and oversee all activities for large, complex Smith+Nephew-sponsored clinical studies from start-up through close-out. • Act as the primary point of contact for internal and external stakeholders, ensuring strong collaboration across cross-functional teams. • Develop and maintain essential study documents including protocols, monitoring plans, and consents. • Manage vendor qualifications and maintain oversight throughout the study lifecycle. • Support site identification and engagement, including investigator meetings and study communications. • Ensure compliance with ICH-GCP, ISO 14155, and regional regulatory requirements. • Monitor study quality through training, compliance reviews, and corrective actions. • Oversee study budgets, timelines, and data integrity using established systems and processes.

What will you need to be successful?

• Bachelor's degree or higher in a scientific, clinical, or related field. • GCP certification and in-depth knowledge of regulatory requirements. • Extensive experience in clinical study management: BS + 6 years, MS + 3 years, or PhD + 1 year. • Strong leadership, project management, and decision-making skills with the ability to handle complex projects independently. • Excellent communication and relationship-building skills in English.

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 Purchase Plan, 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 Flexibility: Hybrid Work Model (For most professional roles) Training: Hands-On, Team-Customized, Mentorship Extra Perks: Discounts on fitness clubs, travel and more!

The anticipated base compensation range for this position is $123,500-$184,775 USD annually or $123,500-$185,250 CAD. 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.

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. Were more than just a company - were 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.

About the Company

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Smith & Nephew Plc

The Group has a history dating back 160 years to the family enterprise of Thomas James Smith who opened a small pharmacy in Hull, England in 1856. On his death in 1896, his nephew Horatio Nelson Smith took over the management of the business. Thomas James Smith black and white photograph Image: Thomas James Smith A few days after the declaration of World War 1 in 1914, Horatio Nelson Smith (the nephew of the company founder T. J Smith) met with an envoy of the French President in London. The company was awarded a contract to supply £350,000 of surgical and field dressings, to be delivered in five months. By the late 1990s, Smith & Nephew had expanded into being a diverse healthcare conglomerate with operations across the globe, including various medical devices, personal care products and traditional and pioneering woundcare treatments. In 1998, Smith & Nephew announced a major restructuring to focus management attention and investment on three business units — wound management, endoscopy and orthopaedics — which offered high growth and margin opportunities. Smith & Nephew was incorporated and listed on the London Stock Exchange in 1937 and in 1999 the Group was also listed on the New York Stock Exchange. In 2001, Smith & Nephew became a constituent member of the FTSE-100 index in the UK. This means that Smith & Nephew is included in the top 100 companies traded on the London Stock Exchange measured in terms of market capitalisation. Today, Smith & Nephew is a public limited company incorporated and headquartered in the UK and doing business in many countries around the world.
COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Medical Devices and Supplies