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Prenosis · 1 day ago

Clinical Project Manager

Chicago, Illinois, United States

Full-time

Hybrid

Mid, Senior Level

$100K/yr - $150K/yr

5+ years exp

Prenosis Inc. is an artificial intelligence company pioneering precision medicine in acute care. The Clinical Project Manager leads all aspects of clinical trials/studies, overseeing study implementation and ensuring high-quality data collection and analysis while collaborating with various internal and external stakeholders.

Artificial Intelligence (AI)BiopharmaHealth CareHospitalMachine LearningMedicalPharmaceuticalPrecision Medicine

No H1B

Responsibilities

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)

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

Monitor sites for quality data collection

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

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

Qualification

Clinical research managementRegulatory complianceProject planningData quality oversightSite recruitmentCross-functional collaborationCommunication skillsLeadership skills

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