Clinical Study Manager - Roseville, United States - Avivomed, Inc.

Description

No Recruiters, pleaseAre you ready to join a supportive company developing a novel neuromodulation device, and to help build our clinical research infrastructure? We are growing the

Clinical Affairs

team 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 Avivomed's 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 our Minnesota office

and reports to the Director of Clinical Affairs.

ResponsibilitiesOversee 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 relationshipsAuthor clinical study protocols and core documentsDevelop clinical evidence dissemination plans, and support publication and presentation material developmentSupport development of clinical messagingOversee advisory boards and physician relationships to support clinical developmentCollaborate cross-functionally to achieve business goalsDevelop and manage clinical study budgets

QualificationsBachelor'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 devicesExperience managing CROsBasic understanding of biostatisticsBudget development and managementExcellent project management and organization skillsExperience interacting with the FDA is preferred

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