Lead Clinical Study Managment (Canada)

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

Clinical research professional responsible for execution and oversight of complex Smith+Nephew sponsored studies. Functions as a project leader within 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?

• Organizational SME responsible for the independent coordination of all study activities from start-up through close-out.
• Ensure successful study execution via project leadership and strong collaboration with study teams including but not limited to Biostatistics, Clinical Operations, Clinical Strategy, Data Management, Medical Affairs, New Product Development, Regulatory Affairs, Study Site Management, and vendors.
• Support and train more junior members of the Study Management function.
• Primary point of contact for internal and external study partners. Responsible for development and maintenance of these professional relationships.
• Assess study feasibility and collaborate on study design.
• Coordinate study public registry activities, regulatory submissions, and study product management.
• Responsible for development of study documents such as protocols, monitoring plans, and consents and for oversight of other study documents such as investigator brochures, case report forms, and clinical study reports.
• Conduct study vendor qualifications and maintain vendor oversight.
• Oversee site management activities being performed by Study Site Management.
• Ensure study quality via team training, stakeholder meetings/alignment, compliance reviews, trending, corrective actions, and escalation.
• Utilize study systems to create and maintain oversight of data integrity, documentation, milestones, issues, systems access, etc.
• Manage study budget planning, accruals, actuals, and reconciliation.
• Support the development and implementation of clinical research standards and improved processes, to add value to the business and improve service levels.

What will you need to be successful?

• Education: Bachelor of Science plus 6 years’ experience, Master of Science plus 3 years’ experience, or PhD plus 1 year experience; qualification and experience in engineering, design, scientific, clinical subject or related field (e.g., Clinical Study Management – medical devices required); GCP certification
• Experience:
• Strong negotiation and professional relationship/communication skills – strong oral and written English
• Expert Study/Project Management, organizational, and decision-making skills with solid understanding of processes – demonstrates understanding and quality delivery of study milestones according to established timelines.
• Expert understanding of customer and business needs within assigned area and general understanding of broader areas.
• Ability to independently handle complex projects, actively manage risk, resolve a wide range of issues, and guide others to solve issues.
• In-depth knowledge of regulatory requirements, ICH-GCP, industry standards and best practices.
• Travel Requirements: up to 25% travel

You. Unlimited. 

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. 

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

Your Future: RRSP Programs, Discounted Stock Options, Tuition Reimbursement 

Work/Life Balance: Flexible Paid Holidays, Flex Holidays, Paid Community Service Day 

Your Wellbeing: Comprehensive health care plan, 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-LS2

#LI- REMOTE

Stay connected and receive alerts for jobs like this 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 our Glassdoor page for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.

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

Read Full Description