Principal Clinical Trial Manager, Clinical Operations

About Us
DELFI Diagnostics, Inc. (DELFI Diagnostics) is developing next-generation, blood-based tests that are reliable, accessible and deliver a new way to help detect cancer. Employing advanced machine-learning methods to whole-genome sequencing data, the DELFI ("DNA EvaLuation of Fragments for early Interception") platform is built to address the highest-burden health challenges. DELFI Diagnostics prioritizes solutions that have the potential to save lives on a global scale, including for historically underserved populations. DELFI Diagnostics’ platform relies on fragmentomics – the discovery that cancer cells are more chaotic than normal cells and, when they die, leave behind tell-tale patterns and characteristics of cell-free DNA (cfDNA) fragments. FirstLook Lung, for individuals eligible for lung cancer screening, is DELFI Diagnostics’ first laboratory-developed screening test and can be part of routine blood work. FirstLook Lung uses millions of data points to reliably identify individuals who may have cancer detected through low-dose CT, including early stage disease with a negative predictive value of 99.8 percent. This test has not been cleared or approved by the FDA.
In our passionate pursuit to radically improve health outcomes, we serve humanity when we:
Lead with Science, Anchor in Pragmatism: We pioneer life-changing science by ensuring quality, transparency, and rigor at all times. We explore thoughtfully, experiment smartly, and deliver impact with conviction.
Build With & For All: We embrace diverse backgrounds to innovate and achieve together. We are not just building a product - we aim to disrupt the path of cancer for all - no matter geography or socioeconomic class 
Put We over I: We are a home for high-performing people. Through teamwork, we build collective intelligence. Each of us wins when those we serve and those who serve with us--win. We show up with empathy, humility, and integrity at every step of the journey.
As a Principal Clinical Trial Manager (Principal CTM) you will be responsible for the successful oversight and management of multiple clinical trials from early development through publication.  The Principal CTM will lead completion of study deliverables through active participation in all aspects of study design, execution, analysis and reporting, vendor selection and management, and oversight of investigator selection and management.  Additionally, the Principal CTM will proactively identify and resolve clinical study issues and participate in process improvement initiatives including, but not limited to, contributing to generation of Standard Operating Procedures (SOPs), implementation of study systems, and collaboration with Clinical Quality and Laboratory staff on study compliance initiatives.

What you’ll do

• 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.

What you’ll have accomplished 12 months from now

• 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 com