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Biobank IT Manager

Frederick National Laboratory for Cancer Research

This is a Contract position in Rockville, MD posted May 27, 2020.

Leidos Biomedical Research, Inc.

(LBR) operates the Frederick National Laboratory for Cancer Research (FNLCR), a Federally Funded Research and Development Center focused on cancer and AIDS research, on behalf of the National Cancer Institute (NCI).

It also manages the federal government’s only vaccine manufacturing facilities and the high-performance Advanced Biomedical Computing Center.

LBR’s Molecular Characterization Laboratory (MoCha) develops and performs clinical assays in support of the NCI’s Division of Cancer Treatment and Diagnosis (DCTD).

As a dedicated and approved government contractor, MoCha is responsible for providing genomic assay support for DCTD-sponsored clinical trials and has developed stringent quality systems to ensure the strictest adherence to regulatory requirements and expectations of patient confidentiality and specimen integrity.

DCTD and MoCha are jointly responsible for the NCI Cancer Moonshot Biobank program, a new and innovative clinical trial which is intended to accelerate cancer research in key strategic areas that were identified by experts convened in 2016 through a “Blue Ribbon Panel” (https://www.cancer.gov/research/key-initiatives/moonshot-cancer-initiative/blue-ribbon-panel).

The strategic areas have in common two core elements: (1) critical scientific and medical questions, the answers to which could rapidly accelerate progress in cancer research, and (2) the need for nationwide participation by a diverse group of research subjects who have agreed to share their biospecimens and/or derived data to contribute to progress in cancer research.

Up to 2,000 longitudinal samples from patients with 10 different cancer types will be collected at biospecimen source sites (BSS) and utilized by researchers studying mechanisms of drug resistance and sensitivity and other important questions.

Next-generation sequencing tests will be performed to inform patient treatment decisions.

Some samples will be sent to FNLCR for patient derived xenograft model development.

A central Biospecimen Core Resource (BCR) will be engaged for sample processing and storage.

A patient and provider engagement website will be used to securely provide information (consent forms, clinical report) to participants/providers, and provide trial information to potential participants.

An electronic consent tool and video will be deployed at the BSS to facilitate engagement.

Clinical and specimen data will be collected in Theradex’s Medidata Rave.

Select clinical, specimen, and inventory data will be available through an online biospecimen catalog system to reduce barriers to researchers interested in using biospecimens for research.

Project data will be uploaded to various NCI data repositories (e.g.

Sequence Read Archive, Cancer Research Data Commons, dbGap, and The Cancer Imaging Archive), which provide access to the broader research community.

This is a challenging and rewarding opportunity to lead the creation of a complex IT system in a high-visibility cancer research setting.

Components of the system will interface with clinical data stores, public databases, researchers, physicians, and cancer patients.

The successful applicant will help orchestrate subcontractors and Federal stakeholder input to produce a smoothly operating, distributed data management system that maintains patient privacy, while providing research data to both scientists and the patients themselves.

KEY ROLES/RESPONSIBILITIES Will work closely with NCI and LBR program leadership and direct the effort to build and integrate systems to support the Cancer Moonshot Biobank project Collaborate with internal and external IT groups to store key clinical and specimen data from multiple BSS collected via Theradex’s Medidata Rave, a cloud-based clinical trial software program, as well as BCR sample processing data and MoCha genomic assay results Collaborate with Theradex to develop a dashboard so that patient demographics, specimen processing and test result data are readily accessible and viewable in real-time to support overall project decision making, particularly by ensuring that accrual goals and milestones based on patient diversity and cancer type are met Work closely with other NCI/LBR IT groups and subcontractors to support development of 1) a website/portal for engaging patients and providers and return of MoCha test results; 2) an online catalog for distribution of biospecimens to researchers, 3) an online electronic consent tool; and 4) integration of data with the appropriate NCI data repositories Ensure security requirements for the IT infrastructure supporting this program are met, specifically the Federal Information Security Management Act of 2002 (FISMA) and National Institute of Standards and Technology (NIST) 800-53 rev 4, including security controls required for a FIPS-199 FISMA moderate system Develop and implement project management standard operating procedures based on Project Management Institute best practices and the U.S.

Department of Health and Human Services Enterprise Performance Life Cycle (EPLC) Work with program leadership to ensure that the budget estimates for projected IT expenditures are as accurate as possible This position will be located in Rockville, Maryland.

BASIC QUALIFICATIONS To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below: Possession of a Master’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research (Additional qualifying experience may be substituted for the required education).

Foreign degrees must be evaluated for U.S.

equivalency In addition to educational requirements, a minimum of four (4) years progressively responsible job-related experience involving IT in health care or life sciences and/or technical project management that includes managing IT projects in support of federal government contracts Experience must include a minimum one (1) year of experience in a leadership role Experience in the agile software development process, Agile, Scrum, Kanban, and how to fit those into the waterfall environment of EPLC.

Must be proficient in Microsoft Project in addition to the Microsoft Office Suite Ability to lead teams through the requirement development phase of multiple new systems, as well as through integration of existing systems to form a new infrastructure Experience managing IT subcontractors, with success in keeping subcontractors aware of software requirements, maintaining progress on deliverables, and holding them accountable to schedules and budgets Knowledge of clinical systems involved in the collection and handling of clinical data, including Personally Identifiable Information (PII) and Health Insurance Portability and Accountability Act (HIPAA), and security systems (FISMA) to protect such data Familiarity with modern software development stacks and enterprise software management tools and techniques, for example, JIRA, Github, Java/Tomcat/Apache, Python-based frameworks, Node.js Must be able to obtain and maintain a security clearance.

PREFERRED QUALIFICATIONS Candidates with these desired skills will be given preferential consideration: Bioinformatics experience with Big Data generated by high-throughput genomics and proteomics assays Knowledge of data cloud systems (AWS, Microsoft Azure, Google Cloud, etc.) Knowledge of infrastructure used to support clinical trials as well as biobanking systems Database experience with Oracle Familiarity with DevOps, continuous integration, and security tools such as Travis, Jenkins, Docker, Nessus, Appscan Knowledge of FISMA requirements, especially FISMA and NIST 800-53 rev 4, and familiarity with security controls required for a FIPS-199 FISMA moderate system Prior experience working in a government or government contractor setting EXPECTED COMPETENCIES Excellent communication skills (written and oral) Ability to work effectively in a matrix and team oriented environment Ability to identify and solve complex problems Strong organizational and multitasking skills Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)