Our small start-up client is adding a Clinical Study Manager to the team. Are you ready to join a supportive company developing a novel neuromodulation device, and to help build the clinical research infrastructure? They are growing the Clinical Affairs team (2nd person in clinical) with the addition of a (Senior/Principal) Clinical Study Manager. This role is filled with growth opportunities and has responsibility to execute clinical development plans for a novel neuromodulation platform technology. Key job aspects include pre-market clinical study operations in partnership with CROs, driving clinical processes to meet business milestones, and evidence dissemination planning. This role requires experience managing clinical study operations of active implantable medical devices, and knowledge of clinical safety and statistical analysis. This position is on-site in the Minnesota office and reports to the Director of Clinical Affairs.

Your role with the company:

• Oversee core clinical study operation activities including study start-up through completion, resource planning for surgical case coverage and key follow-up timepoints, and reporting of study results.
• Manage CRO selection and relationships
• Author clinical study protocols and core documents
• Develop clinical evidence dissemination plans, and support publication and presentation material development
• Support development of clinical messaging
• Oversee advisory boards and physician relationships to support clinical development
• Collaborate cross-functionally to achieve business goals
• Develop and manage clinical study budgets

Desired Profile:

• Bachelor’s degree required with a minimum of 7 years of clinical research experience with medical devices or an advanced degree with a minimum of 5 years of clinical research experience with medical devices.
• At least 2 years of experience must be with active implantable medical devices
• Experience managing CROs
• Basic understanding of biostatistics
• Budget development and management
• Excellent project management and organization skills
• Experience interacting with the FDA is preferred