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GMP Documentation/Sample Management Specialist

Company: Kelly Services
Location: Cambridge
Posted on: April 9, 2021

Job Description:

Kelly Services is currently seeking a Documentation Specialist in Cambridge, MA--to work a contract assignment 12--month duration for one of our top clients.-- Kelly is a full service workforce solutions provider to 98% of the Fortune 100--- companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.--Primary Responsibilities includes:

  • Heavy Paperwork
  • Reviewing biomarker plans
  • Sample management
  • Documentation review, transfer, storage and administrationOur client--is seeking an outstanding candidate who will effectively execute the sample management process across all therapeutic areas. The incumbent will work in close partnership with the clinical biomarker, diagnostics and bioanalytical sciences groups within CBID as well as external partners.
    • The candidate will be responsible for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of patient samples.
    • Coordinate and drive completion of sample management process for all clinical trials supported by CBID.
    • Review documents around sample management and dispositions
    • Coordinates with clinical project teams to determine fate of clinical samples Interfaces with vendors to draft sample transfer documentation
    • Works with legal, where necessary, to draft contracts for sample transfer contracting
    • Oversee finalization of sample disposition activities, including disposal or shipment to long term storage
    • Work closely with key line functions such as Legal, Clinical Operations, Clinical Outsourcing and outside vendors to identify and provide solutions to issues regarding biomarker sample management
    • Responsible for documentation, following SOPs and protocols related to biomarker sample tracking
    • Address questions and requests from CRO or clinical team on sample collections, shipment to vendor for testing, analysis and final disposition.
    • Able to participate in physical lab move from one facility to another.
    • Onsight oversight of equipment and materials transfers between facilities.
    • Act as liaison between laboratory consolidation team and scientific personnel.
    • Ability to follow SOPs and document process of moving materials internally.
    • Excellent knowledge of clinical trials and understanding of the role of biomarkers in clinical studies
    • Familiarity and experience with CDISC/SDTM and related industry standards
    • Works successfully under pressure and with tight timelines.
    • Self-motivated, highly independent, organized detail-oriented
    • Excellent written, organizational and interpersonal communication skills necessary to interface with outside vendors and internal team members across function areas.
    • Technical knowledge to maintain electronic files and experience with LIMS database systems.
    • Microsoft Office proficiencyAPPLY NOW!For immediate consideration, please send your resume in a WORD document to gaut985@kellyservices.comWhy Kelly--?Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly--At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]]

Keywords: Kelly Services, Cambridge , GMP Documentation/Sample Management Specialist, Executive , Cambridge, Massachusetts

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