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Clinical Project Manager I - Biospecimen Research Group

Job ID: req1239
Employee Type: exempt full-time
Facility: Rockville: 9605 MedCtrDr
Location: 9605 Medical Center Drive, Rockville, MD 20850 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc.  The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public’s interest.  

 Position Overview:

PROGRAM DESCRIPTION

The Leidos Biomedical Research, Inc.’s, staff of scientific, technical, and support professionals conduct basic and applied research in cancer and AIDS. It operates and manages the federal government’s only vaccine manufacturing facilities (Vaccine Pilot Plant [VPP] and Biopharmaceutical Development Program [BDP]) and runs the high-performance Advanced Biomedical Computing Center. It also operates the Frederick National Laboratory for Cancer Research, a Federally Funded Research and Development Center focused on cancer and AIDS research.

The Leidos Biomedical Research Group’s Biospecimen Research Group (BRG) supports several projects across the National Cancer Institute (NCI) that require expertise in the infrastructure needed to support the collection and use of human biospecimens for cancer research as well as other areas where scientific knowledge of advanced computing and/or scientific technologies is required.

A flagship proteogenomic program that the BRG supports is the Clinical Proteomic Tumor Analysis Consortium (CPTAC) from the Division of Cancer Treatment and Diagnosis (DCTD). The overall objective of the CPTAC program is to improve our understanding of cancer biology by conducting proteogenomic analysis on selected cancer types where unanswered questions remain about the molecular biology of the disease. This analysis will add a complementary layer of protein molecular biology that facilitates refinement of driver genes, enhances understanding of the pathogenesis through proteomic subtyping, and illuminates dynamic alterations in posttranslational modifications (PTMs) responsible for the dysregulation of cancer signaling networks and pathways. The purpose of this project is to utilize a pipeline to collect, process, qualify, and distribute biospecimens for CPTAC and to collect, analyze, review, store, and distribute the data associated with this research.

A central Biospecimen Core Resource (BCR) will be engaged for biospecimen processing and storage. The BCR will receive samples from various tissue source sites (TSS), process them and redistribute to the characterization centers for genomic and proteomic characterization. The project data will be uploaded to NCI’s Data Commons to enable data analysis by the broader research community.

KEY ROLES/RESPONSIBILITIES

The Clinical Project Manager (CPM I) will be primarily responsible for providing all technical direction to a Leidos Biomed subcontracted BCR. The CPM I in addition will manage few tissue source sites (TSS) that will collect specimens for the program. The responsibilities include the following:

  • Manage the BCR as the primary point of contact (POC) from Leidos Biomed Research Inc. on the technical activities and in support of contractual activities
  • Provide clear objectives for the BCR activity related to the shipment and tracking of biospecimens from multiple sites requiring various shipment conditions.
  • Provide guidance and clear objectives to the BCR for the development of specimen collection kits, specimen storage, the processing of DNA and RNA, and performance of pilots to test new technologies.
  • Provide clear objectives and technical direction for the TSS activities related to collections, shipment and tracking of biospecimens.
  • Work closely with the rest of the CPTAC team and the NCI CPTAC program office to ensure the operational flow of specimen delivery to the characterization centers is running smoothly.
  • Contribute to the development of a CPTAC biospecimen collection protocol and standard operating procedures (SOP) governing the BCR and TSS activities.
  • Hold reoccurring meetings to provide direction to the BCR and TSS with the appropriate team members included.
  • Provide technical expertise in reviewing documents related to biobanking and procurement and offer solutions towards process improvement
  • Facilitate and track shipment of specimens to the researchers through the BCR.
  • Work closely with quality expertise at Leidos Biomed and at the BCR.
  • Monitor the BCR and TSS progress against its schedule and provide status and reports to the CPTAC Biospecimen Lead and Program Manager.
  • Contribute to issue identification, research, and resolution to maintain and improve achievement of BCR, TSS, and programmatic goals.
  • Provide project management expertise, support, and standards as needed.
  • Review budgets accurately, review and approve invoices, and track financial information from subcontracts.
  • Provide subcontract oversight and maintain coordination and communications among all parties.

Qualifications:

BASIC QUALIFICATIONS:

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

  • Possession of a Bachelor's degree in a biomedical or science-related field from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency
  • In addition to education requirements, a minimum of six (6) years of progressively increasing responsibilities and experience in project management in clinical studies and/or biospecimen-related fields
  • Exhibit the strong written and oral communication skills needed to work with non-technical and technical staff
  • Minimal travel required; four (4) trips per year
  • Possess knowledge of federal regulations
  • Ability to prioritize multiple tasks/projects
  • Experience with scientific technical writing and documentation
  • Scientific competency in a field relevant and related to cancer research
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration: 

  • Master's degree
  • Experience managing a biospecimen repository, or working as a technician or manager responsible for day-to-day activities related to biobanking and/or biospecimen collection
  • Knowledge of best practices in biobanking operations and biobanking data standards
  • Experience in biospecimen sciences research with knowledge of pre-analytical influence
  • Formal educational training in project management (MBA or PMP)

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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