Clinical Study Manager

Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary hypertension (PH). We will continue to combine our proprietary, innovative PRINT® Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes.

Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.

The Clinical Study Manager (CSM) will be part of the Clinical Operations Department, which is responsible for planning, executing, managing and closing studies associated with the company clinical development plans. The CSM is a proven leader in clinical development with study management experience in the pharmaceutical or device industry. The CSM provides leadership and support to members of the multidisciplinary program teams, internally and externally, and can successfully thrive in a virtual clinical model.

The CSM reports to the Senior Director of Clinical Operations and may be based at Liquidia’s headquarters in Research Triangle Park, North Carolina, or remote.

• Bachelor’s with a minimum of five years of experience in clinical research, with at least two years of clinical project/study management.
• Experience qualifying & managing external vendors (e.g. CRO, Call Center, Central labs, etc.).
• Experience managing clinical project team personnel.
• Experience leading program operational teams through the start-up, study conduct, data management, and report writing of clinical studies.
• Experience reviewing and editing protocols and clinical study reports.
• Demonstrates knowledge of Good Clinical Practices and all applicable US regulations governing clinical research, as well as working knowledge of the FDA submission process.
• Strong understanding of clinical trial budget/resource forecasting and management.
• Excellent organization and communication skills, including experience dealing with decision makers, such as physicians, IRB members, and FDA staff.
• Demonstrates problem-solving and interpersonal skills. Must have a ‘can-do’ attitude and a strong desire to take ownership of many different projects.
• Ability to work independently and manage multiple timelines, while maintaining team focus
• Demonstrated ability to exercise judgment and determine appropriate action to a variety of problems of varying complexity.
• Demonstrated ability to manage multiple deadlines.

• Strong desire to join a small company and work in a fast-paced environment.
• Ability to work with remote teams and to negotiate with external providers.
• Must be detail oriented, highly organized, reliable, and accurate.
• Must be a motivated self-starter, adaptable, and capable of working within a matrix environment.
• Must display sound judgment and discretion as well as problem solving abilities, especially within a team environment.
• Strong computer skills, including Microsoft programs and project management software.
• Compelling interpersonal verbal, written and presentation skills in communication with the internal and external customers.
• Must have the ability to accommodate international and domestic travel up to 30% at the request of the business.

• Act as a customer advocate throughout the clinical development project lifecycle.
• Understand and support global program goals including site identification and assessment, patient/subject recruitment, Key Opinion Leader (KOL) and Steering Committee…