Principal Clinical Trial Manager

Summary

Join DELFI Diagnostics, a company developing next-generation cancer detection tests, as a Principal Clinical Trial Manager. You will oversee and manage multiple clinical trials, from early development to publication. Responsibilities include coordinating deliverables, managing resources and vendors, ensuring regulatory compliance, and contributing to process improvements. The ideal candidate possesses a Bachelor's degree (or higher) in a science or health-related field, 10+ years of clinical operations experience, and in vitro diagnostics experience. DELFI offers competitive compensation, including full medical, dental, and vision coverage, four months of paid parental leave, flexible time off, and a five-day winter break.

Requirements

• Bachelor’s degree (or higher) in science or health-related discipline
• 10 years of direct clinical operations experience in a sponsor (Pharmaceutical or Biotech) and bachelor’s degree; or 8 years and a Master’s degree; or a PhD with 5 years experience; or equivalent experience
• Industry experience within in vitro diagnostics (IVD) required
• Demonstrated experience in participating in the development, implementation, management, and completion of large, regulated clinical trials
• Ability to assist in preparation of a clinical development plan, clinical trial design, protocol writing, and essential documents
• Strong understanding of GCPs, ICH, and knowledge of regulatory requirements
• Well developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization
• Ability and willingness to travel ~10-15% of the time

Responsibilities

• Coordinate and manage production of key deliverables for clinical studies to achieve on-time enrollment and study completion. Identifies barriers to timely and successful study execution and proposes solutions, with regular reporting of study performance metrics
• Manage internal resources, external partners, consultants, vendors, and internal/external budgets to ensure the timely and cost-effective implementation of the clinical strategy for one or more clinical studies
• Assess and recommend CROs and preferred vendors for implementation of clinical studies. Subsequently manages CRO relationships and contracts for study execution, where applicable
• Ensure audit readiness at all times by assessing and mitigating study compliance with all regulatory requirements. Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management is required
• Provide input in the development of clinical trial related documents including but not limited to: protocols, case report forms, informed consents, timelines, monitoring plans, laboratory manuals, training materials, and site initiation visit slide presentation
• Maintain proficiency in understanding of early detection practices within oncology and an in-depth knowledge of molecular testing practices within multiple cancer types
• Manage all clinical aspects of study: budget and metrics; operations; study document development and review (study specific plans, eCRF Guidelines, lab manuals, etc.)
• Assess and recommend CROs and preferred vendors for implementation of clinical studies. Subsequently manage CRO relationships and contracts for study execution, where applicable
• Manage the study submission to IRB in coordination with CRO, as appropriate
• Oversee the execution of site training, either performed by Delfi Diagnostics or CRO partners, and ongoing educational interventions to assure compliance with study protocols
• Ensure clinical trials are executed in compliance with the protocol and ICH/GCP guidelines/regulations: participate in the planning of quality assurance activities and coordinate resolution of audit findings of vendors and CROs; ensure audit-ready condition of clinical trial documentation
• Consult with cross-functional teams on data collection, regulatory questions, and protocol execution as it pertains to the Delfi Diagnostics assay
• Establish and maintain effective communication and collaboration with functional area peers, including research, clinical lab operations team, regulatory, quality assurance, and commercial, as well as thought leaders to meet program objectives
• You will have taken ownership of the financial aspects of assigned program(s) and trial(s) including collaboration with finance partners to generate and review forecasts and accruals and escalates variances as appropriate
• You will have supported Senior Management by reviewing the unique enrollment requirements for a clinical study and provided a strategy for successful trial enrollment and completion
• You will have assisted with authoring and review of multiple departmental SOPs

Preferred Qualifications

• Oncology experience in clinical research
• Clinical experience (oncology, cancer center, inpatient or outpatient or physician office setting) a plus
• Familiarity with ISO 20916 and/or 14155 standards preferred

Benefits

• 100% paid medical, dental and vision premiums for employees and dependents
• 4 months fully paid parental leave
• Flexible Time Off
• 5 day winter break in December
• A meaningful mission and strong company culture
• $180,000 - $210,000 a year
• Compensation is a combination of bonus, equity, and benefits