Biomarker Services Project Manager

Description

Position Summary

The Biomarker Services Project Manager (PM) is responsible for the comprehensive management of all aspects of assigned biomarker services projects involving CND's diagnostic technologies. This role encompasses support for pharmaceutical or biotech sponsored trials, Investigator Initiated Trials (IITs), and Clinical Trial Services across academic and industry settings. The PM serves as a primary liaison between sponsors, academic collaborators, clinical sites, external vendors, and internal CND team members while coordinating with sponsor Clinical Trial Teams (CTT).

The position coordinates cross-functional activities with CND testing laboratory and CND Logistics and Production departments to deliver exceptional project support and management. The PM maintains exceptional quality standards through effective communication, customer service, and organizational practices while ensuring compliance with regulatory requirements, Good Clinical Practices (GCP), and relevant policies and procedures. Working in partnership with the Research Operations, the PM is accountable for successful execution, management, and delivery of support services for clinical trials in a professional, timely, efficient, quality, and budgetarily appropriate manner while meeting company and regulatory requirements.

Job Responsibilities

Trial Management and Operations

• Proactively manage project-level operational aspects including but not limited to study status, client communications and inquiries, kit requirements/delivery/inventory, and coordination with the testing laboratory as needed.
• Support study startup processes including study kick-off meetings, facilitate site trainings, study onboarding documents, kit and manual collateral, and where applicable.
• Coordinate with sponsor CTT to monitor kit logistics, testing progress, sample quality, data readiness, and site performance across multiple, multi-site studies.
• Serve as point of contact for study 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.

Regulatory Compliance and Documentation

• Work with Regulatory, Quality, and Laboratory teams to ensure all testing and reporting activities comply with applicable U.S. and international regulations, as well as internal policies.

• Manage study-specific documentation including protocols, data forms, site training materials, manuals, and SOPs, where applicable.
• Monitor adherence to ICH/GCP guidelines, HIPAA requirements, ABAC, GDPR and other privacy regulations, and applicable federal, state, and local regulations.
• Identify gaps and develop policies, procedures, and associated cross-functional internal and external trainings.

Team Collaboration

• Attend internal and study sponsor working groups and vendor status meetings, ensuring timely completion and distribution of meeting minutes, where applicable.
• Collaborate with internal teams including Business Development, laboratory operations, R&D, legal, regulatory, quality, informatics, and biostatistics.
• Understand study protocol, diagnostic technologies, and regulatory compliance.
• Coordinate development of study-specific training materials and conduct team training sessions.

Quality Assurance and Risk Management

• Monitor performance of studies level testing, site adherence to study manual and sample quality, ensuring adherence to CND SOPs, ethical standards, and diagnostic testing procedures.
• Manage vendor qualification, quality assurance checks and responses to sponsor audits for accuracy, timeliness, and regulatory compliance.
• Lead risk management efforts, developing contingency plans and escalating risks as appropriate.
• Monitor quality of testing deliverables and identify opportunities to improve training, execution, and quality control.

Reporting

• 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 leadership regarding vendor selection, project plans, timeline management, quality standards, and risk areas.

Data Tracking and Reporting

• Collaborate with informaticians and data review leads to schedule delivery of study data, validate diagnostic performance, and prepare reports for regulatory agencies, sponsor, and internal stakeholders.
• Monitor study progress and report key performance indicators related to operational support of studies.
• Support generation and delivery of study documentation and resulting diagnostic research test pathology reports.
• Coordinate contributions to study reports and regulatory submissions, as required.
• Monitors study report and data deliverables, keeps internal team informed of timelines, and ensures timely delivery of finalized results to the sponsor study team.
• Ensures data files are structured according to the specifications outlined in the approved study data transfer plan (DTP)

Knowledge, Skills & Experience

• 5 years of clinical research experience, including proven success as a Clinical Research Coordinator or Clinical Project Manager on large, multi-site studies, with progressively increasing responsibilities within a large health system, life sciences company, or CRO
• Minimum of 2-3 years of experience in a coordinator or project management role
• Exceptional attention to detail and drives a process-oriented approach
• In-depth understanding of clinical study processes, regulatory requirements including Good Clinical Practice (GCP) guidelines, as well as other applicable rules and regulations in diagnostics.
• Proven track record managing day-to-day activities of multiple and multi-site studies.
• Strong familiarity with project management, client support services, site management, and related areas.
• Demonstrated experience in study data file quality control (QC) and transfer.
• Proficiency in secure file transfer protocols (sFTP) and electronic data capture (EDC) systems.
• Demonstrated ability to work independently in fast-paced environments with proven multitasking capabilities
• Excellent communication, analytical, and customer service abilities.

Education, Certifications, and Licensures

• Bachelor's degree, in life sciences required
• Professional certifications (SOCRA, ACRP, Project Management) preferred

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 is hybrid, with on-site presence at CND's Scottsdale, AZ headquarters a minimum of three (3) days per week; exceptional candidates may be assessed for remote roles.