Delfi Diagnostics is a Johns Hopkins spinoff focused on the non-invasive detection of cancer at earlier stages, when it is most curable. DELFI uses artificial intelligence and whole genome sequencing to detect unique patterns of DNA fragmentation in the blood of patients with cancer. These analyses are performed through simultaneous examination of millions of DNA sequences using machine learning to identify tumor-specific abnormalities.

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 the Director of Clinical Data Management, you will serve as the department leader for all data management components of clinical trials covering management, infrastructure, and processes to meet regulatory requirements. You will develop and execute the strategy for the Clinical Data Management function, including policies and procedures, data collection technology and vendor oversight.

What you’ll do

Evaluate, revise, and execute on the current Clinical Data Management strategy
Evaluate processes for eCRF development, eCRF completion guidelines, EDC set-up, UAT, edit checks, data review and query resolution, locking activities, and reporting. Identify gaps and implement updates to improve operational efficiency and regulatory compliance
Evaluate processes for data transfers, lock/unlock process, and study database archiving. Identify gaps and implement updates to improve operational efficiency and regulatory compliance
Contribute to infrastructure requirements for interactive data visualization and analytic tools for reporting and data QC
Contribute to infrastructure requirements for systems integration between biosample and clinical data
Manage and develop internal talent
Develop policies to manage CROs, EDC developers, and other external data management vendors
Develop and maintain departmental policies in accordance with regulatory requirements
Support regulatory submissions including FDA audit readiness, presentation, and response
Drive the hiring process, including developing complex recruiting within assigned requisitions and, provide an extraordinary, high-touch, best-in-class experience for all stakeholders consistent with Delfi's core values.
Have an agile mindset, focusing on delivery of clinical data management goals including supporting individual studies as needed

What you’ll have accomplished 12 months from now

You will have developed or updated processes and policies that advanced Clinical Data Management objectives, setting the foundation for future clinical trials
You will have facilitated and supported the achievement of key product corporate goals

What you’ll bring to DELFI

Required
Bachelor’s degree or equivalent combination of education/experience in science or health-related
10+ years of clinical data management experience (12+ for Senior Director) in pharmaceutical, medical device/diagnostic company or CRO.
Cross-functional leadership as it relates to clinical study data collection and analysis efforts.
Mastery of GCP, ICH, knowledge of clinical data management standards and regulatory requirements for EDC systems and data transfers
Experience working at a sponsor company
Excellent organizational, written, and verbal communication skills
Ability to work independently as well as part of a cross-functional team
Demonstrated ability to achieve goals
Flexible attitude to adjust to changing needs
Preferred
Industry experience within in vitro diagnostics (IVD) highly preferred; medical device experience can substitute in part for IVD experience
Experience with oncology trials and biomarker studies

An equal opportunity employer

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.

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