Responsibilities and Capabilities:

• Manage the quality and compliance of assigned clinical project(s) ensuring that they meet the highest standards for scientific quality, integrity and ethics and are conducted in accordance with global clinical procedures, study protocols, GCP and all applicable regulations.
• Plan and strategize with cross functional team members (R&D, Marketing, Quality, and other stakeholders) to define, implement and execute clinical strategies in support of business objectives.
• Demonstrate a comprehensive understanding of the therapeutic areas and competitive landscapes for assigned clinical project(s).
• Oversee the planning and execution of assigned clinical projects to ensure that deliverables are completed on time and within budget. Develop and manage metric reporting tools as needed to track project timelines and deliverables. Provide regular and ad hoc reporting of metrics to Clinical Affairs leadership.
• Manage activities related to clinical strategy and study design, global applications, submissions, and product launches for assigned clinical project(s) as the clinical subject matter expert.
• Develop Clinical Investigation Plans (CIPs), Informed Consent Forms (ICFs), Investigator’s Brochure’s (IBs), Clinical Study Management Plans, Case Report Forms (CRFs), Clinical Study Reports (CSRs) and other essential clinical study documents.
• Review and provide input on the development of other essential clinical study documents related to clinical data management, clinical statistics, site management & monitoring, clinical safety management, and clinical product management.
• Develop and manage clinical study budgets and monthly financial reviews, including invoice review/approval and accruals for assigned clinical project(s).
• Manage compliance for required reporting, including but not limited to IDE annual reports, clinicaltrials.gov, and overseas notified bodies/competent authorities.
• Assist in preparing regulatory submissions, including clinical data packages, for regulatory bodies like the FDA or EMA.
• Oversee the Trial Master File (TMF) to ensure that study files are current, accurate, complete and audit-ready.
• Oversee study and site-level management of the Clinical Trial Management System (CTMS) to ensure that study and site details are current, accurate and complete.
• Interact with and/or oversee interactions with investigational sites, vendors, key opinion leaders (KOLs) and consultants.
• Support Clinical Data Management in the ongoing review of study data and database cleaning activities.
• Manage external contractors/suppliers for assigned clinical project(s) to ensure that deliverables are completed on-time, within budget, and are consistent with the scope of work.
• Coach and ensure successful and effective relationships between study teams and investigational site personnel.
• Provide critical thinking and leadership support for issue escalation related to clinical study activities.
• Provide support for internal or external audits/inspections and ensure resolution of audit/inspection findings related to assigned clinical projects.
• Conduct periodic clinical study data reviews with internal and external stakeholders.

Requirements:

• Minimum bachelor’s Degree (BS/BA) in life sciences or equivalent combination of training and experience (MA/MS preferred)
• Minimum 5+ years of experience in clinical research (medical device or biotechnology)
• Minimum 3+ years of experience in managing clinical projects
• Strong working knowledge of domestic and international clinical research regulations and guidelines, Good Clinical Practice (GCP) and current industry practices related to the conduct of clinical studies
• Proficiency with Microsoft Suite tools (Outlook, Word, Excel, PowerPoint, OneNote, To-Do, SharePoint, etc.)
• Strong knowledge of clinical study processes and systems (eTMF, CTMS and CDMS)
• Strong interpersonal and communication (oral and written) skills
• Strong organizational skills, attention to detail, critical thinking and analytical skills
• Able to manage and delegate multiple tasks and prioritize importance of tasks/projects
• Ability to understand and interpret technical, scientific, and clinical information as it applies to product approval activities
• Ability to lead teams to translate issues into actions, make decisions and influence outcomes
• Ability to travel up to 30% (or more during peak times)

Compensation: $110,000 - $175,000/year depending on experience

Please note that an application and resume must be completed and submitted for consideration for this opportunity.

Pulmonx Corporation is an Equal Opportunity Employer and embraces diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any characteristic protected by applicable law.

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