Principal Clinical Trial Manager, Clinical Operations
Remote
Clinical Development – Clinical Development /
Full-Time (Remote) /
Remote
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 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
- You will be a respected member of the clinical development team, having contributed to the collaborative delivery of key trials and analyses
What you’ll bring to DELFI
- Required
- 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
- Familiarity with ISO 20916 and/or 14155 standards preferred
- 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.
- Preferred
- Oncology experience in clinical research
- Clinical experience (oncology, cancer center, inpatient or outpatient or physician office setting) a plus
What we offer full-time employees
- 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. Actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skillset, years & depth of experience, certifications & relevant education, geography.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
This position is not eligible for agency partnership. Resumes and outreach from staffing representatives will be declined.
