• Manager , Clinical Data

    Takeda Pharmaceuticals (Boston, MA)
    …career? If so, be empowered to take charge of your future at Takeda. Join us a Manager , Clinical Data Validation Engineer in our Cambridge, MA office. At ... and oversight of clinical trial deliverables. As part of CDE, the Clinical Data Validation Engineer (DVE) group leads validation and reconciliation… more
    Takeda Pharmaceuticals (12/06/24)
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  • Manager , Cleaning Validation

    Bristol Myers Squibb (Devens, MA)
    …and in their personal lives. Read more: careers.bms.com/working-with-us . **Position:** Manager , Cleaning Validation , Validation Engineering **Location** : ... **Position Summary** **Manage the development and maintenance of the cleaning validation and changeover cleaning verification program elements for a fully automated,… more
    Bristol Myers Squibb (12/11/24)
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  • Lead Clinical Documentation Integrity…

    Spaulding Rehabilitation (Cambridge, MA)
    …updates as needed. * Provides assistance to the CDI team (IRF, LTCH, SNF) for validation of clinical review and development of a compliant physician query. * ... reimbursement issues identified through daily and retrospective documentation reviews and aggregate data analysis. * Instructs clinical staff on best practices… more
    Spaulding Rehabilitation (12/03/24)
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  • Biostatistician/Statistical Project Manager

    Harvard University (Cambridge, MA)
    …officers, protocol specialists and database managers + Experience with independently analyzing data from clinical trials using standard statistical techniques + ... Working with project leadership on assignment of work (eg, validation , data requests, studies) to MS-level Biostatisticians...other infections). Duties include, but are not limited to, clinical trial and observational study review; data more
    Harvard University (11/20/24)
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  • Clinical Nurse Educator - Ambulatory

    Cambridge Health Alliance (Somerville, MA)
    Clinical Nurse Educator - Ambulatory **Date Posted:** 06/05/2024 **Requisition Number:** 7825 **Location:** CHA Somerville Campus **Work Days:** various start and ... training and support for preceptors. Collaborates with preceptor, orientee, and manager to assess individual learning needs, develop and implement learning plans… more
    Cambridge Health Alliance (12/04/24)
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  • Manager , Operations (Remote)

    Prime Therapeutics (Boston, MA)
    …results, and implements controls to monitor consistent use of the solution. + Data Validation : Performs the technical and administrative functions to lead the ... and drives every decision we make. **Job Posting Title** Manager , Operations (Remote) **Job Description** + Operations: Manages team...Benefit Analysts in organizational data validation projects to support major system… more
    Prime Therapeutics (12/19/24)
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  • Biostatistician/Statistical Project Manager

    Harvard University (Cambridge, MA)
    …officers, protocol specialists and database managers + Experience with independently analyzing data from clinical trials using standard statistical techniques + ... leadership on: + Assignment of work (protocols, ancillary studies, data and specimen requests, validation , etc.) to... trials and observational studies, and as statistical project manager for IMPAACT's clinical trials involving regulatory… more
    Harvard University (11/17/24)
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  • Senior Manager , GMP Quality Control

    Sumitomo Pharma (Boston, MA)
    …and suppliers of drug substances and drug products used for investigational clinical trials and/or commercial phases. The Senior Manager ensures compliance ... us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . **Job Overview** The Senior Manager of GMP Quality Control oversees GMP compliance of… more
    Sumitomo Pharma (12/14/24)
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  • Manager of Assessment Reporting…

    State of Massachusetts (Everett, MA)
    …The Manager of Assessment Reporting and Analysis oversees the data analysis and reporting systems for the Commonwealth's statewide assessments, including the ... of Elementary and Secondary Education (DESE) seeks to fill the position of Manager of Assessment Reporting and Analysis in the Office of Student Assessment Services… more
    State of Massachusetts (10/30/24)
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  • Scientific Manager , Scientist I, Biomarker…

    Takeda Pharmaceuticals (Boston, MA)
    … Pharmacology, Clinical Operations, Procurement, R&D and IT Quality, and Clinical Data Solutions to support clinical bioanalytical and biomarker ... scientific operations and logistics with external vendors thereby helping create high quality clinical data . **How you will** **contribute:** + The scientific … more
    Takeda Pharmaceuticals (11/28/24)
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  • Quality Manager for High Complexity CLIA…

    Nanobiosym, Inc. (Cambridge, MA)
    …business and regulatory expectations. * Ensure the timely and compliant generation of clinical and validation data required to support regulatory submissions ... Testing CLIA LAB. The role and requirements are below. The CLIA ( Clinical Laboratory Improvement Amendments) Quality Manager will provide quality and… more
    Nanobiosym, Inc. (11/27/24)
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  • Manager , QC BioAnalytical

    ThermoFisher Scientific (Plainville, MA)
    …timely qualification of in-process and release testing of toxicological, clinical , and commercial grade biopharmaceuticals, qualification/ validation of ... otherwise untreatable diseases **How will you make an impact?** The Manager , Quality Control BioAnalytical provides leadership and scientific and technical expertise… more
    ThermoFisher Scientific (12/06/24)
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  • Senior Manager , Manufacturing Execution…

    Bristol Myers Squibb (Devens, MA)
    …Bristol Myers Squibb is seeking a highly skilled and experienced Senior Manager for our Manufacturing Execution Systems (MES) team. The successful candidate will ... manufacturing sites. This role is critical in driving operational excellence, ensuring data integrity, and supporting our mission to deliver innovative medicines to… more
    Bristol Myers Squibb (12/23/24)
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  • Pharmacovigilance (PV) Systems Operations…

    Takeda Pharmaceuticals (Cambridge, MA)
    …submit expedited reports to regulatory authorities and business partners and conduct validation testing of data migrations and safety upgrades; coordinate ... LOCATION:** Cambridge, MA **POSITION** : Pharmacovigilance (PV) Systems Operations Manager - GPSE **POSITION DESCRIPTION:** Takeda Development Center Americas, Inc.… more
    Takeda Pharmaceuticals (11/22/24)
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  • Manager , Upstream Process Development

    ThermoFisher Scientific (Plainville, MA)
    …skills to join our growing Process Development team. **Job Title: Manager - Upstream Process Development - Gene Therapy** **Location/Division Specific Information** ... characterization, scale up of gene therapy molecules from pre clinical to clinical and commercial phase. As...junior team members. + Collaborate with clients, ensures accurate data and presentations to presented clients. + Collaborate with… more
    ThermoFisher Scientific (12/24/24)
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  • Manager , Utilities Engineer

    Bristol Myers Squibb (Devens, MA)
    …Support and coordinate site startup and commissioning and support validation activities for specified equipment. Oversee distribution system for compressed ... Devens campus: + Biologics Large Scale Commercial Manufacturing + Biologics Clinical Manufacturing + Biologics Cell Bank Manufacturing + Biologics Development and… more
    Bristol Myers Squibb (12/01/24)
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  • Senior Laboratory Technologist

    Bio-Techne (Waltham, MA)
    …to perform high complexity molecular biology procedures under the direction of the Clinical Operations Manager and Laboratory Director + Follow the laboratory's ... and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers… more
    Bio-Techne (11/06/24)
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  • Development Scientific Director

    Sanofi Group (Cambridge, MA)
    …strategy in consistency with the planned statistical analysis and is involved in study data validation and review processes, support the CRD for the Clinical ... of the data and investigations of safety cases with the Clinical Trial Team (Monitoring Teams) or Pharmacovigilance. **Main Responsibilities** + Contributes to… more
    Sanofi Group (11/07/24)
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  • Medical Device Senior Manufacturing Engineer

    MetaOption, LLC (Cambridge, MA)
    …Manufacturing, Design for Manufacturing (DFM), SolidWorks Proficiency:, Process Validation , New Product Development, Statistical Analysis Software, Vendor Management ... Work Hours Per Day: 7 Note : The hiring manager is specifically seeking candidates with hands-on experience in...by Management. * Review engineering product specifications and CAD data /drawings as part of the design review process to… more
    MetaOption, LLC (11/29/24)
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  • Specialist, Commissioning Engineer I

    Bristol Myers Squibb (Devens, MA)
    …Engineer I will be part of the Commissioning team reporting to Sr. Manager , Commissioning Engineering and support clinical and commercial Devens manufacturing ... Quality Assurance, Quality Control, Qualification, Manufacturing Engineering, Facilities operations/maintenance, Validation and Manufacturing. **Key Responsibilities:** + Executes and/or Leads… more
    Bristol Myers Squibb (12/24/24)
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