Clinical Affairs Manager

Innova Medical Group, Inc. is seeking a Clinical Affairs Manager to lead the clinical aspects of medical device projects, clinical affairs activities, and special projects. The successful candidate will have a strong background in clinical research, regulatory affairs, and leadership.

Requirements

• Select Clinical consultants and Clinical Research Organizations (CROs) and manage their contracts
• Recruit, hire, train, manage Clinical staff and their career development
• Prepare and track Clinical budget
• Allocate resources and budgets to various department projects and oversee their progress
• Participate in preparation of Clinical operating plans and objectives
• Supervise the implementation of clinical programs and track their progress
• Oversee the planning of new clinical programs and the development of clinical protocols
• Review and approve submissions of protocols and reports to regulatory authorities and Institutional Review Boards (IRBs) or Ethics Committees (ECs)
• Interact with Investigators and IRBs on financial and compliance issues
• Oversee the proper collection, analysis and presentation of clinical data
• Review and approve final Case Report Forms, Edit Checks and Clinical Study Databases
• Oversee development and maintenance of department SOPs
• Assure compliance of department activities to relevant regulations, department SOPs, and corporate requirements
• Develop and manage the process for clinical regulatory document preparation and submissions for clinical studies

Benefits

• Competitive salary
• Benefits package
• Opportunities for career growth and development