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Clinical Project Manager

  • Remote
    • Chicago, Illinois, United States
  • Clinical

Job description

About Prenosis

Prenosis Inc. is an artificial intelligence company pioneering precision medicine in acute care. Our Immunix™ precision medicine platform drives the development of precision products and enables real-time delivery of optimal therapy. We've created and validated the first FDA-authorized AI biomarker for sepsis, the Sepsis ImmunoScore™.

At Prenosis, we:

  • Put patients first

  • Disrupt with evidence

  • Excel with integrity

  • Go far together

Our staff collectively defined these corporate values to demonstrate how our teams contribute to meaningful and authentic change in U.S. healthcare. We value our diverse talent, strive to foster a culture of continuous learning, and aim to maintain a feeling of belonging and shared sense of purpose.

Prenosis is headquartered in Chicago Illinois and generally operates on Central Time Zone.

The Clinical Project Manager leads all aspects of one or more clinical trials/studies from inception to conclusion, from initial feasibility studies to post-market safety and efficacy evaluations. This role supports and manages all aspects of our clinical research program, including protocol development, hospital site recruitment and management, and regulatory compliance. Working cross-functionally with internal teams and external partners, the Clinical Project Manager oversees study implementation and collaborates closely with our data analytics team to ensure high-quality data collection and analysis. This position requires a strategic thinker who can both develop and/or co-develop research plans and execute them effectively while maintaining the highest standards of scientific integrity in a nimble, fast-paced environment.

Responsibilities

Research Program Strategy

  • Ensure alignment of research program goals and objectives with business needs

  • Collaborate with internal and external stakeholders (such as advisors, quality/regulatory, R&D, etc.) to develop and implement clinical study strategies

  • Contribute and review clinical study protocols in alignment with business goals and objectives

  • Represent Prenosis at relevant industry trade shows and networking events.

  • Host internal and external meetings, as needed, to brief, update and align with key stakeholders

  • Establish and maintain relationships with key opinion leaders (KOLs)

Project Planning and Execution

  • Develop and manage project timelines, budgets, and resource allocation.

  • Coordinate project activities and ensure adherence to regulatory guidelines and company policies.

  • Identify potential project risks and develop and implement corrective action strategies as needed and monitor effectiveness of corrective action strategies.

  • Prepare and present project status reports to senior management and external stakeholders.

  • Support presentation and publication development.

  • Collaborate with senior leadership to manage budget

  • Ability to lead, coach and direct cross-functional team(s).

  • Maintain oversight of quality regulations and GCP requirements

  • Ensure all project documentation is complete, accurate and compliant with regulatory standards.

  • May serve as a main point of contract for Academic Research Organization (ARO) or Contract Research Organization (CRO) partners

  • Devise and implement processes and tools to accelerate study start-up process

  • Support and manage resources needs for studies

  • Contribute to the development of support materials, presentations, briefing materials, relevant reports, and other materials, working with Subject Matter Experts (SMEs) and marketing team on the presentation/publication of clinical material

  • Communicate/educate as company expert for clinical research

Data Quality and Oversight

  • Monitor sites for quality data collection

  • Collaborate with Data Manager and data science team to ensure data quality in collection and accuracy

Site Management and Recruitment

  • Develop funnel of study sites for recruitment

  • Recruit new sites and Principal Investigators

  • Serve as engagement leader, working closely with site leaders and ensure project success

  • Collaborate with Clinical Research Associate(s) to oversee study activation functions: contract negotiation, budget preparation and negotiation, IRB submissions and follow-through to approval

  • Maintain, steward, build and manage relationships, through in-person and virtual meetings, phone calls, and emails, with both sites and external organizations

Other duties as assigned by the organization to support research study conduct as this list is not meant to be all inclusive.

Expected frequency and duration of travel: 20%

Job requirements

Qualifications and Experience

Required:

  • Bachelor’s degree or equivalent combination of education, training, and experience.

  • 5+ years of management experience in one of the following disciplines: Clinical research, nursing, medicine, pharmacology, clinical science, engineering or public health

Preferred:

  • Graduate degree preferred

  • 7+ years of management experience in one of the following areas: Clinical research, medicine, pharmacology, clinical science, engineering or public health

What We Offer

  • Comprehensive Medical, dental, and vision coverage

  • 401(k) with company match

  • Unlimited time off

  • Major opportunity for career development to make significant impact at an exciting growth-stage company

  • Collaborative and innovative work environment

  • Chance to make a real impact on patient care

  • Opportunity to work on cutting-edge AI technology in healthcare

Salary range: $100,000 - $150,000 per year

Prenosis is an Equal Opportunity Employer

Must be eligible to work in the US without sponsorship

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