Job Summary:

Manages overall operation of a clinical research project of significant complexity and critical to the business, including project planning, budget, resource management.  May assist with other projects as needed. 

Duties & Responsibilities:   

• Works cross-functionally to determine necessity and type of research required
• Manages overall operation of a clinical study (including its design and planning, budget, resource management) to support FDA regulatory submissions and scientific publications
• Recommends and implements innovative process ideas to impact clinical trials management, including contingency plans
• Acts as project resource to study, site, and in-house personnel regarding product under evaluation and clinical trial conduct
• Adheres to applicable ethical regulatory and clinical standards by participating in the creation, review and approval of departmental operating procedures
• Ensures compliance with all regulatory policies, procedures and/or guidelines during clinical studies
• Acts as a cross-functional liaison with external and internal parties to ensure study plan and progress aligns with business development strategies
• May serve as a mentor/coach for junior members of the clinical research team

Qualifications:  

• Bachelor's degree in a scientific discipline plus 8+ years of experience in clinical research
• Previous demonstrated success in planning and execution of IDE clinical studies
• Able to communicate in a clear and confident manner with all levels of the organization and with external parties; excellent writing skills
• Thorough knowledge and demonstrated application of GCP, FDA, CFR and local regulations
• Demonstrated ability to work well on a team
• Detail-oriented, exhibit initiative; self-starter who can work independently once projects are assigned
• Proficiency in Microsoft Excel and PowerPoint.
• Competency in statistical interpretation and/or analysis of clinical data

Desired Qualifications:

• Demonstrated success in clinical project management
• Experience with regulatory affairs
• People management/development experience