Clinical Project Manager

PRIMARY FUNCTION

Endogenex is a medical device company developing an endoscopic solution for type 2 diabetes, which affects over 400 million people worldwide. This position represents an exciting opportunity to make an impact in the pivotal stages of clinical development for a novel therapy based on innovative technology.

As a member of the Clinical team, the Clinical Project Manager will work closely with study sites, CROs, Consultants, and multi-functional teams within the company. This individual will be involved in all aspects of clinical study execution, including IRB/EC submission, data management, study monitoring, and CRO oversight, among others.

The position requires a high level of interpersonal skills and attention to detail.

Domestic and international travel is a requirement.

REQUIREMENTS

· Bachelor's degree in life sciences, healthcare, or a related field; advanced degree preferred.

· Proven experience (10 years) in clinical project management within the medical device industry, preferably managing pivotal trials.

· Comprehensive understanding of clinical trial operations, GCP, and regulatory requirements, particularly in the medical device field.

· Strong project management skills, including planning, execution, risk assessment, and problem-solving abilities.

· Excellent communication and interpersonal skills to effectively collaborate with internal teams, external stakeholders, and investigators.

· Proficiency in relevant software and tools for project management, data analysis, and documentation.

Preferred Qualifications:

· Certification in project management (PMP or equivalent).

· Experience working within a start-up or clinical-stage medical device company.

RESPONSIBILITIES

· Develop and execute comprehensive project plans, including timelines, milestones, and budgeting, to ensure the successful implementation of the pivotal trial.

· Manage and oversee CROs, vendors, and third-party contractors, ensuring their alignment with project objectives, quality standards, and compliance with regulatory requirements.

· Monitor trial progress, identify potential risks, and implement mitigation strategies to ensure the trial stays on track.

· Prepare and maintain trial-related documentation, including study manuals, reports, and regulatory submissions.

· Provide input and/or lead the development of study management plans based on study protocols and internal SOPs, including clinical monitoring plan, data management plan, etc.

· Review and approve monitoring visit reports.

· Perform co-monitoring or site audit as needed.

· Review and approve study technology (e.g. EDC, ePRO) development documentations. Perform UAT as needed.

· Provide timely feedback to Clinical Affairs management on process improvement and resource demand to support quality execution of clinical studies.

Other Responsibilities:

Perform other duties and responsibilities, as required, to lead the clinical affairs department of Endogenex.

This role is on-site in Minneapolis, MN.

Special Physical Demands and Working Conditions

The physical demands and work environment characteristics described here represent those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

· Physical demands: While performing the duties of this job, the employee is occasionally required to walk; sit; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; balance; stoop; talk and hear. Specific vision abilities include close and distance vision. Ability to occasionally lift and/or move up to 35 lbs.

· Work environment: Fast-paced work environment. While performing the duties of this job, the employee will experience minimal in/out of the office noise. Employee must be capable of transporting themselves to various business locations. If using own motor vehicle, must have current, valid state driver’s license and proof of insurance that at least meets current residence’s state minimum requirements. US and OUS travel may be required.

Job Type: Full-time

Pay: From $150,000.00 per year

Benefits:

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

Medical Specialty:

• Endocrinology
• Gastroenterology

Schedule:

• 8 hour shift

Education:

• Bachelor's (Required)

Experience:

• clinical project management: 10 years (Preferred)

Ability to Commute:

• Minneapolis, MN 55441 (Required)

Work Location: In person

Salary : $150,000