Position: Senior Clinical Project Manager
Location: Remote – Need to live near major airport (~30% travel)
Reports to: Director Clinical Operations
Help Advance What’s Possible in Medical Device Clinical Research
At Lungpacer Medical, we’re working to make a meaningful difference for patients through innovative medical technology. We’re looking for an experienced Senior Clinical Project Manager who is ready to take ownership of complex clinical studies and help move innovative therapies from clinical development toward real-world impact.
This is more than a project management role. You’ll be a key clinical leader—bringing together internal teams, investigators, clinical sites, vendors, consultants, and other partners to keep studies moving forward with quality, compliance, and patient safety at the center of every decision.
If you thrive in an environment where you can lead, solve problems, influence outcomes, and make an impact, we’d love to hear from you.
What You Will Do
As our Senior Clinical Project Manager, you will:
- Lead complex clinical studies from start-up through closeout, ensuring studies remain on track, within budget, and compliant with GCP, ICH, FDA, ISO, and applicable regulations.
- Own study execution and timelines, proactively identifying risks, resolving issues, and keeping cross-functional teams aligned.
- Partner with internal and external clinical experts to develop and manage key study documents, including protocols, CRFs, informed consent forms, and operational plans.
- Lead site selection and activation, including contract and site budget review.
- Oversee clinical monitoring activities, including monitoring plans, reports, schedules, and corrective actions.
- Drive study safety oversight, including adverse event tracking and reporting, safety trend review, and coordination with Medical Monitors, Clinical Events Committees, and Data Safety Monitoring Boards.
- Develop study training plans and oversee training documentation.
- Prepare and oversee annual, interim, and final clinical study reports.
- Lead investigator meetings, study calls, and other clinical project meetings.
- Oversee investigational device allocation, distribution, tracking, and reconciliation.
- Identify and address protocol, SOP, GCP, and regulatory deviations and ensure appropriate corrective actions.
- Develop and monitor study metrics to provide Clinical leadership and key stakeholders with clear visibility into study progress, risks, and performance.
- Mentor and support other clinical team members, sharing your expertise in GCP, ICH, and clinical trial execution.
- Contribute to clinical department initiatives, including SOP development, process improvements, and training.
- Manage multiple projects and shifting priorities in a fast-paced, collaborative environment.
What You Bring
- Bachelor’s degree required; preferably in a science, healthcare, or related discipline.
- 10+ years of clinical research experience.
- Strong experience managing clinical studies from start-up through closeout.
- Demonstrated knowledge of GCP, ICH, FDA, ISO, and other applicable clinical research regulations and standards.
- Strong understanding of medical terminology and clinical trial activities within a clinical development program.
- Proven ability to independently manage complex projects, timelines, vendors, budgets, and deliverables.
- Excellent written and verbal communication skills.
- Strong proficiency with Microsoft Word, Excel, and PowerPoint.
- Willingness and ability to travel up to 30%.
You Are a Great Fit If…
You are someone who:
- Takes ownership. You don’t wait for problems to become bigger—you identify risks early and take action.
- Knows how to lead without always having direct authority. You can bring investigators, vendors, consultants, and internal teams together around a common goal.
- Balances the big picture with the details. You understand that successful clinical programs require both strategic thinking and meticulous execution.
- Communicates clearly. You know how to keep stakeholders informed without creating unnecessary complexity.
- Is comfortable with change. Priorities can shift, and you know how to adapt while keeping critical deliverables moving.
- Is naturally organized. You can manage multiple studies, deadlines, stakeholders, and competing priorities without losing sight of what matters most.
- Is a problem solver. You don’t simply identify an issue—you work collaboratively to find a practical solution.
- Enjoys developing others. You are willing to share your experience, mentor colleagues, and help strengthen the clinical team.
- Cares about the patient behind the data. You understand why clinical research quality, compliance, and execution matter.
Why Lungpacer?
At Lungpacer, Patients Come First.
We believe innovation happens when talented people collaborate, challenge conventional thinking, and stay focused on making a meaningful difference for patients.
Our values—Trust, Respect for People, Integrity, and Innovation—shape how we work and how we make decisions.
As a Senior Clinical Project Manager, you’ll have the opportunity to contribute your expertise to innovative medical device clinical programs while working alongside a passionate, growing team.
Lungpacer Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Compensation: Actual compensation will be determined based on factors including experience, qualifications, skills, education, geographic location, and internal equity. In addition to base salary, this position may be eligible for bonus and a comprehensive benefits package.
Ready to make a real impact in patients’ lives and help bring life-changing therapy to the world? Send your resume and cover letter to [email protected] today and join Lungpacer’s mission to redefine respiratory support. Your clinical expertise and passion for patient care can help shape the future of medicine.
