Sr. Manager, Clinical Compliance

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

The post holder is responsible for managing the clinical compliance and training program, ensuring clinical study systems and procedures are robust and in accordance with international standards, training internal staff to meet those standards, and monitoring compliance with the systems. Success in the role will require close interaction with global colleagues across Global Clinical and Medical Affairs (GCMA) and key stakeholders. A strong understanding of clinical quality processes and standards in the clinical research industry is required.

What will you be doing?

• The post holder will be responsible for supporting internal and external site audits of studies managed by the Global Clinical Research Operations (GCRO) team. In addition, the post holder will conduct compliance checks within the GCMA team department.
• The post-holder will be responsible for developing and overseeing maintenance of the Clinical Quality System covering the conduct of clinical studies within GCMA, collaborating with local teams (CRO or other S&N sites) to ensure they are using and understanding the current version of the SOPs.
• The post-holder will lead, manage, and develop a team of individual contributors supporting the clinical quality program.
• The post holder will be responsible for providing an effective training program for Clinical Affairs study staff and other members of the overall GCMA team as appropriate
• The post-holder will maintain up-to-date knowledge of regulations, GCP standards and other guidelines relevant to best practice in the conduct of clinical research. Accountable for review of applicable new and changing regulations and ensuring compliance with regulations including GCP and data integrity requirements.
• The post-holder will be accountable for providing leadership on continuous improvement in Good Clinical Practice standards, study design, study management and reporting.
• The post-holder will oversee the Clinical CAPA process, ensuring it provides a mechanism for identification and mitigation of events which have the potential to cause or contribute to a negative impact on patient, product, process, clinical study, regulatory status and/or overall business.

What will you need to be successful?

• Bachelor degree in Life Sciences, Science or Mathematics/Statistics required.
• Proven and significant experience (at least 7 years) of clinical research project management in medical devices.
• Proven track record in people management/leadership with excellent skills in influencing outside of line management responsibilities.
• Driving license required for business travel.
• Competencies: Project management skills, communication and influencing skills, team working and customer focus. Good IS skills (especially Microsoft packages).

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
• Investing In Your Future: RRSP Programs, Tuition Reimbursement
• Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Floating Holidays, Paid Community Service Day
• Your Wellbeing: Medical, Dental, Vision, Employee Assistance Program, Parental Leave
• Training: Hands-On, Team-Customized, Mentorship
• Extra Perks: Discounts on fitness clubs, travel and more

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