Clinical Documentation and Process Specialist

DELFI Diagnostics, Inc.; United States; Remote; USD 135,000 - 170,000; Full time

Job summary

A leading company in cancer detection is seeking a Staff Specialist for Clinical Development. You will manage the eTMF system, ensure compliance, and enhance clinical processes. This role requires strong collaboration skills and extensive clinical research experience. Join us to make a significant impact in healthcare!

Qualifications

• 8+ years of clinical research experience, including 3 years in a medical device or IVD company.
• Proficiency in regulations governing clinical studies.

Responsibilities

• Serve as primary administrator for Clinical Development’s eTMF system.
• Oversee training activities and track compliance.
• Partner with Clinical Quality Assurance for audit readiness.

Skills

Collaboration

Attention to Detail

Communication

Education

Bachelor's degree in life science

Tools

eTMF systems

Job description

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.

DELFI has 1-2 designated in-office working days each week for employees who live within within 50 miles of Palo Alto CA or Baltimore MD offices

The Staff Specialist, Clinical Development Functional Excellence works in direct partnership with Clinical Development study teams and closely with key stakeholders in Quality, Regulatory Affairs, IT/Software, Legal and other functions to maintain the eTMF and other clinical systems, optimize Clinical Development processes to enhance efficiency, track compliance and training activities, develop and report KPIs/metrics, and ensure audit readiness. You will report to the Vice President, Clinical Development. May require occasional travel to clinical sites or vendor locations.

What you’ll do

• Serve as primary administrator for Clinical Development’s eTMF system, managing user access, roles, and permissions. Serve as the liaison between users and the eTMF vendor.
• Collaborate with Software Engineering and IT teams to implement eTMF system upgrades, migrations and integrations with other clinical systems through the Change Control process
• Develop and implement eTMF workflows that align with clinical trial processes. Prepare document indexes mapping study records to their eTMF location based on the TMF Reference Model or study-specific requirements.
• Oversee training activities including tracking compliance, training matrix development, preparation of training materials, conducting training and competency assessments as needed
• Be responsible for tracking and reporting of key performance indicators on Clinical Development studies, processes and clinical systems.
• Lead the development, implementation, deployment and periodic review of standardized processes, templates, and training materials in collaboration with process owners across Clinical Development functions, including authoring SOPs and Work Instructions as directed.
• Evaluate Clinical Development policies and standard operating procedures, identifying opportunities to ensure consistency across clinical trials and improve operational excellence and efficiency.
• Partner with Clinical Quality Assurance to ensure Good Clinical Practice and Good Document Practice compliance within Clinical Development, and support internal/external audit and regulatory inspection-readiness activities.
• Support evaluation and selection of new Clinical Development systems in collaboration with Clinical Development Leadership and other key stakeholders, as needed
• Be a subject matter expert within Clinical Development regarding regulations governing clinical trials
• Other duties as assigned by supervisor

What you’ll have accomplished 12 months from now

• Developed a strong partnership with Clinical Quality Assurance and Software Quality Assurance
• Developed a thorough understanding Clinical Development systems, policies and procedures, identifying current compliance risks and opportunities for improvement
• Partnered with Clinical Quality Assurance to develop and implement DELFI’s strategy to ensure inspection-readiness of DELFI’s clinical study programs
• Under the guidance of the Vice President, Clinical Development, develop a roadmap to improve Clinical Development functional excellence

What you’ll bring to DELFI

• Required
• Bachelor's degree or equivalent combination of education/experience in life science, health care or health-related field
• 8+ years of clinical research experience with at least 3 years in a medical device or IVD company
• 3+ years of experience with eTMF systems (eg, Veeva Vault, TransPerfect Trial Interactive, ClinEvo or similar systems)
• Proficiency in regulations governing the conduct of clinical studies including 21CFR812, ICH-GCP, ISO14155 and ISO20916
• Experience supporting and responding to internal audits and regulatory inspections
• Proven ability to collaborate cross-functionally, coach colleagues and identify fit-for-purpose, compliant solutions
• Excellent attention to detail, organization and communication skills
• Preferred
• Experience with system validation processes
• Experience building new Clinical Development operational processes in a start-up environment
• Experience in authoring SOPs
• Experience in Clinical Operations study oversight and execution
• Previous experience in the evaluation of IT systems supporting clinical study management, such as eTMF, CTMS, Document Control or EDC

$135,000 - $170,000 a year

The total compensation for this role includes salary, 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.