This role is responsible for management of assigned Global Clinical Operations (GCO) team activities across all S+N franchises in the region of responsibility to ensure that assigned GCO programs of work are executed in a timely, compliant and efficient manner. This role is additionally responsible for strategic oversight of any areas of GCO activities globally where the region of responsibility is the lead region and is also required to manage relationships in all sites in region that S+N have strategic partnerships with. This individual will have full vendor oversight where GCO activities are outsourced in the region of responsibility, in order to ensure quality and timely study execution, collaborative study teamwork and alignment between the vendor and the business at all times. Such activities are intended to expedite evidence generation to support regulatory approval, marketing claims, reimbursement and Post market surveillance for all Smith + Nephew products globally. In partnership with Global Clinical Strategy, Medical Affairs, Data Analytics, Safety, Regulatory, Reimbursement and Market Access, the role, through the internal or external (ie vendors) team, ensures that assigned studies are executed to a high quality and in a timely manner in their region, in compliance with applicable standards.
This Senior Manager will have oversight, training and development of direct or indirect reports (ie either internal, or external assigned vendor staff) to ensure an engaged, efficient and cohesive team operating at a high level with their global counterparts and the rest of the CMA team.
- Responsible and accountable for assigned GCO program delivery in region, for all S+N franchises, as well as accountable for key deliverables globally where GCO activities are led from region of responsibility.
- Responsible for any assigned vendor management and oversight, as it relates to clinical study management of assigned studies, to ensure sponsor confidence in vendor activities and to ensure appropriate and effective sponsor oversight as well as effective operational execution. Proactively identifies and resolves any foreseen issues, ensures collaborative sponsor/vendor working, schedules and oversees vendor governance meetings, acts as sponsor/vendor liaison.
- Sets strong direction to assigned staff to ensure that the study teams effectively plan, develop and implement clinical study documentation including, but not limited to, clinical study protocols, clinical monitoring plans, Investigator Brochures, clinical study reports, and other essential study documentation.
- Responsible for ensuring strong ownership and accountability from assigned team to perform site selections, site training, effective monitoring and on time reporting globally. Responsible for ensuring effective team use of Clinical Trial Management Systems (CTMS), eTMF and EDC to ensure best practice study management and efficient use of systems and resources to enable timely study execution and delivery.
- Effectively manages the GCO department budget relating to assigned studies- including managing studies run through the internal team or external venders (outsourcing) - and study specific budget forecasting, accruals, payments and tracking including associated vendor management, contracts and agreements.
- Ensures adherence of study conduct with applicable regulations and S+N SOPs for studies in region/responsibility. Responsible for ensuring team adherence to all Clinical Compliance requirements, including deviation reporting, CAPA development (including actions and effectiveness checks), and SOP revisions and improvements.
- Ensures effective oversight of all study sites working as partners to S+N CMA in region, to ensure collaborative approach and maintain effective, productive relationships with the strategic partners.
We are open to someone being based out of any major US Smith+Nephew location
We will also consider a remote based employee
Master's Degree or equivalent experience in life sciences, medical discipline or related field.
Certification/Training through Professional Society (e.g. ACRP, SoCRA) or equivalent is preferred.
- 8+ years relevant clinical research experience, with 3+ years leadership experience within the medical device/healthcare industry leading a clinical operations team.
- Strong people development experience
- Current knowledge of Global GCP guidelines, ISO14155 and local applicable regulations are essential.
- Experience and Knowledge in Medical Device, Regenerative Medicine and Tissue Regulations
- Broad knowledge of the global clinical research and device development process.
- Strong execution track record around clinical studies.
- Strong vendor management experience
- Knowledge of advanced wound management, orthopaedics, sports med and regenerative medicine (preferred).