The posting
Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.
We are currently looking for a Senior Specialist - Clinical Study Management, who will be responsible, with limited guidance, for execution and oversight of complex S+N sponsored studies via management of study and global level activities. Functions as a project leader within cross-functional study teams. Ensure 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?
- SME responsible, with limited guidance, for the coordination of all study activities from start-up through close-out in large projects.
- Ensure successful execution of studies 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 Clinical Study Management and Study Site Management functions.
- Represent the study team as the project leader and primary point of contact for internal and external study/global level activities.
- Responsible for development and maintenance of these professional relationships.
- Assess study feasibility and contribute to and collaborate with study team on study design.
- Coordinate with cross-functional teams to support and oversee study public registry activities and regulatory submissions.
- Responsible for development of study/global level 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/global vendor qualifications and maintain vendor oversight.
- Support identification of potential study sites, oversee site management activities being performed by Study Site Management, and ensure site engagement through study newsletters and Investigator meetings.
- Accountable for coordination and oversight of study product and supplies.
- Ensure study quality via team training, team meetings/alignment, compliance reviews, trending, corrective actions, and escalation.
- Utilise study systems to create and maintain oversight of study level data integrity, documentation, milestones, issues, systems access, etc.
- Manage study budget planning, accruals, actuals, and reconciliation.
- Ensure study related activities are carried out in accordance with the appropriate regional regulations and GCP guidelines. This will usually be ICH GCP for medicines and ISO 14155 for Medical Devices, within the ISO9001 quality system, and any other applicable GCP guidelines, such as NMPA Medical Device GCP or Japan GCP.
- Maintain an up-to-date knowledge of applicable business units.
- Support the development and implementation of clinical research standards, to add value to the business and improve service levels.
- Represent Global Clinical Research Operations at relevant cross functional project meetings.
- Liaise with Clinical Strategy and commercial teams, where appropriate, to ensure effective study alignment with product strategy throughout the lifetime of the study.
What will you need to be succesful?
- Bachelor of Science or greater; qualification and experience in engineering, design, scientific, clinical subject or related field (e.g., life sciences, nursing, pharmacy)
- BS plus 4 years' experience or MS plus 2 years' experience or PhD
- GCP certification required
- Strong negotiation and professional relationship/communication skills - strong oral and written English
- Strong Study Management/Project Management, organizational, and decision-making skills with solid understanding of processes - demonstrates understanding and quality delivery of study milestones according to established timelines.
- Strong understanding of customer and business needs within assigned area and general understanding of broader areas
- Ability to handle diverse projects/problems, actively manage risk, and resolve a variety of issues in creative ways
- In-depth knowledge of regulatory requirements, ICH-GCP, industry standards and best practices 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 our Employee Inclusion Groups on our website www.smith-nephew.com Your Future: Generous annual bonus and pension schemes, Save As You Earn share options Work/Life Balance: Flexible vacation and time off, paid holidays and paid volunteering hours so we can give back to our communities Your Wellbeing: Private health and dental plans, healthcare cash plans, income protection, life assurance and much more Flexibility: Hybrid working model (for most professional roles) Training: Hands-on, team-customised mentorship Extra Perks: Discounts on gyms and fitness clubs, salary sacrifice bicycle and car schemes and many other employee discounts Sales roles: Choose between a company car or a generous cash car allowance
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