Find & Apply For Healthcare Administrator Jobs in Plymouth, Minnesota

Job Summary We are seeking a dynamic and strategic Clinical Program Manager tosupport the planning, execution, and day-to-day management of clinical development programs to support regulatory approvals, market adoption, and post-market evidence generation. This individual will play an important cross-functional role, working closely with Regulatory, R D, Quality, Marketing, and external stakeholders, and in partnership with clinical leadership, to ensure clinical programs are designed and executed to the highest scientific and ethical standards. Responsibilities Clinical Strategy & Program Support

• Support the development and execution of clinical development plans aligned with business goals and regulatory requirements (FDA, EU MDR, etc.), in partnership with clinical leadership.
• Provide day-to-day program management from study design through execution, data analysis, and clinical study reporting.
• Serve as a key point of contact for cross-functional clinical teams, regulators, and key opinion leaders (KOLs), escalating strategic decisions to clinical leadership as needed. Study Design & Execution
• Manage pivotal, feasibility, and post-market clinical studies, including protocol development, site selection, and data quality oversight.
• Help implement risk mitigation strategies for study timelines, budgets, and regulatory compliance.
• Track key performance indicators (KPIs) to monitor trial progress and site performance. Regulatory & Compliance
• Partner with Regulatory Affairs to support clinical sections of regulatory submissions (e.g., IDE, PMA, 510(k), CE Mark).
• Support audit readiness and contribute to responses to regulatory queries or deficiency letters.
• Ensure adherence to

GCP, ICH

guidelines, ISO 14155, and applicable ethical standards.

• Support CAPA (Corrective and Preventive Actions) processes when issues arise. Stakeholder & Team Support
• Support and mentor clinical team members, including clinical project managers, CRAs, and medical writers, in partnership with clinical leadership.
• Promote a culture of clinical excellence, quality, accountability, and continuous improvement.
• Maintain strong working relationships with external investigators, clinical sites, CROs, and advisory boards. Data & Evidence Strategy
• Support data-driven decision-making and contribute to the generation of clinical evidence to support reimbursement, publication, and market access strategies.
• Support the analysis, interpretation, and dissemination of clinical data to internal and external stakeholders, including clinical leadership, clinicians, and customers. Qualifications
• Bachelor's degree in a scientific, clinical, or related field required; advanced degree (RN, PharmD, or equivalent) a plus.
• Minimum 5-7 years of experience in clinical affairs or clinical research, preferably within the medical device industry.
• Experience supporting or managing clinical programs, including contributing to FDA or EU regulatory submissions.
• Strong knowledge of regulatory, clinical, and ethical requirements in global markets.
• Excellent verbal and written communication, problem-solving, and interpersonal skills, high level of attention to detail.
• Proficient in MS Office, Word, Excel and data analytics platforms.

Work environment:

Fast paced work environment. While performing the duties of this job, the employee will experience in/out of the office noise at a minimal level. Must be capable of transporting self to various business locations. If you use your own motor vehicle, you must have a current, valid state driver's license and proof of insurance coverage that at least meets current residence's state minimum requirements. US and OUS travel may be required. Join us to lead innovative clinical programs that make a meaningful difference in patient care! We are committed to empowering our leaders with the tools they need for success while fostering a vibrant, collaborative work environment dedicated to excellence in healthcare delivery. Endogenex is an Equal Opportunity Employer.

Pay:

$125,000.00 - $150,000.00 per year

Benefits:

401(k) Dental insurance Employee assistance program Flexible spending account Health insurance Health savings account Life insurance Paid time off Vision insurance

Work Location:

In person