The Clinical Project Manager position will perform a wide variety of activities to support the startup and completion of clinical research studies.
Achieves study objectives by working with team members to set project priorities and milestones and resolve project conflicts
Assesses the operational feasibility of studies and recommends execution and risk mitigation plans
Co-monitors as needed
Develops and tracks study timelines and quality metrics
Ensures appropriate clinical resources are available for the clinical project
Ensure GCP and regulatory compliance is maintained
Leads the development of study-related documents including study protocols, informed consent documents, study manuals and plans, trial master files, case report form design, etc.
Maintains professional expertise through familiarity with therapeutic area and clinical research literature
Manages clinical project from concept through clinical study report completion
Participate in CRO and other vendor selection, negotiation and management, including monitoring of associated budgets and contracts
Participates in meetings with investigative sites, key opinion leaders and consultants as needed
Plays a part in the analysis , summary , and reporting of clinical data through the course of the study
Proactively identifies and resolves issues, and participates in process improvement initiatives as required
Responds promptly and appropriately to study questions and issues raise by investigational sites, vendors, monitors and consultants
Evaluates monitoring reports with significant finding to confirm appropriate conclusions and actions taken
Help in the training and development of clinical staff
Ensure potential study risks are escalated when appropriate
Performs other duties assigned
Respicardia is a high growth, fast paced small organization. The ability to be productive and successful in an intense work environment is critical. Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be less than 30% of work time.
5+years clinical research experience
Bachelor’s and/or master’s degree in a scientific discipline
CRA certification (ACRP) is a plus
Excellent organization, leadership and problem-solving skills
Excellent written and verbal communication skills
Experience in leading cross-functional teams to meet goals and metrics
Success at managing global studies a plus
Experience in writing clinical study protocols, informed consent forms and other clinical documents
Proficient computer skills, specifically with Microsoft office suite (Word, Excel, PowerPoint, and Outlook)
Solid understanding of FDA and other regulatory requirements that may impact global clinical studies
Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management
Founded in 2006 and headquartered near Minneapolis, Minnesota, Respicardia® is dedicated to improving the lives of heart failure patients by developing implantable therapies designed to improve Respiratory Rhythm Management and cardiovascular health. The remed?® System is an innovative implantable stimulation device designed to restore natural breathing during sleep for patients with Central Sleep Apnea.
Respicardia® is committed to improving cardiovascular health…
one breath at a time™.