Job details
Job type full-time
Full job description
About us
Our mission is to cure cancer through high performance, accessible early cancer detectionThat means saving lives.
Delfi diagnostics is a johns hopkins spinoff focused on the non-invasive detection of cancer at earlier stages, when it is most curableDelfi uses artificial intelligence and whole genome sequencing to detect unique patterns of dna fragmentation in the blood of patients with cancerThese 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 timesWe explore thoughtfully, experiment smartly, and deliver impact with conviction.
Build with & for all: we embrace diverse backgrounds to innovate and achieve togetherWe 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 peopleThrough teamwork, we build collective intelligenceEach of us wins when those we serve and those who serve with us-winWe show up with empathy, humility, and integrity at every step of the journey.
About the role
As a cra manager you will be responsible for multiple responsibilities ranging from full-time/contract cra management, coordinating and leading clinical monitoring activities, overseeing the cro clinical/site management activities and conducting site management or monitoring activities, as neededThe cra manager will be responsible for ensuring high-quality monitoring deliverables are met on multiple clinical studies.
What you’ll do
Provide expert operational oversight and guidance to support prioritization of monitoring activities, review and assess the work performed, compliance to clinical monitoring plans (cmps), and development of contingency plans, among others
Oversee the hiring and selection of, onboarding/training and performance of full-time and contract crasIncludes implementation of professional development and performance evaluations
Participate in managing the resource needs and availability of the monitoring teamEnsuring projects are suitably resourced and staffing needs are identified in a timely fashion, resolving potential resourcing conflicts to facilitate mutually beneficial resolutions
Support the training and development of clinical monitoring personnel by creating study tools and training materials and delivering training.
Coordinate, manage, and oversee clinical monitoring activities from site start up activities to database lock
Conduct qualification review, initiation, interim and close out visits and provide visit reports as per monitoring guidelines, as needed
Assist in ensuring audit readiness, by ensuring internal and external etmf/tmf are up to date at all times, and may be a part of the qc process for reviewing the etmf at regular intervals
Ensure that study samples/assessments flow as required per protocol is well coordinated between the various stakeholders (cros/vendors/delfi) from site to the central and primary labs.
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
You will have capitalized on the resources provided by the delfi clinical operations team to quickly come up to speed and have taken ownership of high-quality data monitoring and priority monitoring oversight for delfi’s first clinical study.
You will have conducted interviews, completed and hired multiple full-time and/or contract cras to adequately support delfi’s clinical development pipeline.
You will have supported the ctm and senior management by reviewing monitoring proposals from cros and evaluating feasibility of monitoring strategy (including oversight of both brick and mortar and virtual sites)
You will have successfully assisted the ctm with the monitoring strategy and kick off of a large (>10,000 patient) study
You will have assisted with review of multiple departmental monitoring sops
You will be a respected member of the clinical development team, having contributed to the collaborative delivery of key trials and analyses
You will have acquired new expertise related to oncology diagnostic clinical trials and actively benefiting from mutual knowledge exchange with your colleagues
What you’ll bring to delfi
Bachelor’s degree (or higher) in science or health-related discipline
8+ years of direct clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits) at a pharmaceutical, biotech or cro companyDiagnostic and/or medical device experience preferred.
Oncology experience preferred
Demonstrated experience in participating in the development, implementation, management, and completion of at least one major clinical trial.
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 good clinical laboratory practices (gclps) 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 ~5-10% of the time.
Industry experience within in vitro diagnostics (ivd) preferred; pharmaceutical, biologics or medical device experience can substitute in part for ivd experience strongly preferred
Clinical experience, oncology, cancer center, inpatient or outpatient or physician office setting experience a plus
An equal opportunity employer
We are an equal opportunity employer and value diversity at our companyWe do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
