Clinical Research Project Manager

Clinical Research Project Manager The Clinical Research Project Manager (CRPM) is responsible for the comprehensive management of all aspects of assigned clinical studies involving CND's diagnostic technologies. This role encompasses industry-sponsored trials, Investigator Initiated Trials (IITs), and Clinical Trial Services across academic and industry settings. The CRPM serves as the primary liaison between sponsors, academic collaborators, clinical sites, external vendors, and internal CND team members while leading and coordinating Clinical Trial Teams (CTT). The position coordinates cross-functional activities with Research and Development (R&D) laboratory and CND Logistics and Production departments to deliver exceptional project support and management. The CRPM maintains quality standards through effective communication, customer service, and organizational practices while ensuring compliance with regulatory requirements, Good Clinical Practices (GCP), and company policies. Working in partnership with the Senior Director, Biomarker Services, the CRPM is accountable for successful planning, execution, and completion of trials to evaluate diagnostic product performance and clinical utility within established timelines, budgets, and quality parameters. This role supports Research Operations with Biopharma. Job Responsibilities: Trial Management and Operations Proactively manage end-to-end operational aspects of clinical trials from study start-up through closeout, including timeline establishment, budget development, resource allocation, and alignment with diagnostic development goals. Lead study startup processes including Study Kick-off meetings, and where applicable, Trial Master File (TMF) setup, site selection, and finalization of Clinical Trial Agreements and budgets. Coordinate with Clinical Trial Teams to monitor study progress, sample collection, data integrity, and site performance across multiple, multi-site studies. Serve as primary point of contact for pharmaceutical sponsors and CROs regarding trial operations involving diagnostic testing, facilitating clear communication and prompt issue resolution. Oversee site logistics including kit distribution, inventory management, data transfer, and results reporting. Support clinical sites with scheduling, training coordination, and ongoing operational support. Job Responsibilities: Regulatory Compliance and Documentation Ensure all trial activities comply with applicable U.S. and international regulations, maintaining accurate documentation per trial protocols, regulatory submissions, and internal policies. Develop and manage study-specific documentation including protocols, informed consent forms, investigator training materials, manuals, SOPs, and regulatory dossiers, where applicable. Ensure accurate filing and maintenance of Trial Master Files per company SOPs and regulatory standards, where applicable. Coordinate regulatory submissions and support market approval processes for diagnostic technologies. Monitor adherence to ICH/GCP guidelines, HIPAA requirements, and applicable federal, state, and local regulations. Job Responsibilities: Team Leadership and Collaboration Chair Clinical Trial Team working groups and vendor status meetings, ensuring timely completion and distribution of meeting minutes filed in TMF, where applicable. Collaborate with internal teams including Business Development, laboratory operations, R&D, legal, regulatory, quality, and biostatistics. Train and mentor clinical team members on study protocols, diagnostic technologies, and regulatory compliance. Coordinate development of study-specific training materials and conduct team training sessions. Job Responsibilities: Quality Assurance and Risk Management Monitor performance of sites, sponsors, and vendors, ensuring adherence to study protocols, ethical standards, and diagnostic testing procedures. Conduct quality assurance checks and review vendor responses to audits for appropriateness, timeliness, and regulatory compliance. Lead risk management efforts, developing contingency plans and escalating potential study risks to Senior Director as appropriate. Monitor quality of vendor deliverables and identify opportunities to improve training, execution, and quality control. Job Responsibilities: Financial Management and Reporting Develop and monitor study budgets, approve vendor invoices, and oversee resource allocation to meet project milestones. Review and approve client invoices in collaboration with Accounting team to ensure timely investigator payments, if applicable. Track completion of project-specific milestones and deliverables, reporting on project metrics to leadership. Provide regular updates on trial progress to Senior Director regarding vendor selection, project plans, budget and timeline management, quality standards, and risk mitigation. Job Responsibilities: Data Management and Reporting Collaborate with biostatisticians to analyze study data, validate diagnostic performance, and prepare reports for regulatory agencies and internal stakeholders. Monitor trial progress and report key performance indicators related to operational support of studies. Review and approve relevant study documentation and resulting diagnostic research test pathology reports. Coordinate contributions to clinical study reports and regulatory submissions, as required. Requirements 5-10 years of clinical research experience including success as a clinical research coordinator for large, multi-site studies with increasing levels of responsibility serving within a large health system, life sciences company or CRO. At least 2-3 years of serving in a senior coordinator or CRPM role. Therapeutic experience in neurology highly preferred. Experience in Phase II or III clinical studies for drug development or large-scale validation studies. In-depth understanding of clinical study processes, diagnostic regulatory requirements and GCP guidelines. Proven track record managing day-to-day activities of multiple and multi-site studies. Strong familiarity with project management, alliance management, site management, and related areas. Demonstrated ability to work independently in fast-paced environments with proven multitasking capabilities. Excellent communication, analytical, and customer service abilities. Education, Certifications, and Licensures: Required: Bachelor's degree in Life Sciences, Nursing Licensure or Pharmacy. Preferred: Master's degree and/or professional certifications (SOCRA, ACRP, Project Management). Special Training: CITI research training as needed. Other: Combination of seated and standing work to complete the core functions of the role. Sit and stand for long periods of time. Visual acuity and analytical skills. This position requires full-time presence at CND's Scottsdale, AZ headquarters five (5) days per week, with remote work opportunities available based on successful completion of deliverables and management approval.

Created: 2026-03-13