• Merck & Co. (Rahway, NJ)
    …protocol in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and ... scientistsRequired experience and skills: - Solid knowledge of clinical research regulatory requirements (eg, GCP and...knowledge of clinical research regulatory requirements (eg, GCP and ICH) - Ability to manage multiple competing… more
    HireLifeScience (03/26/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …to the transition of the TMF to Insmed at end of study. Partner with Quality Assurance team to help clinical study team with audits/inspections for CRO/vendors ... and Best Workplaces for Millennials™ lists.OverviewAssist in the delivery of Clinical Operations objectives by providing operational support to the clinical more
    HireLifeScience (02/16/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …well as other research areas centered around rare diseases and immune disorders.SummaryThe Senior Director of Clinical Operations will manage clinical ... the clinical operational and overall delivery and tactical execution of the clinical studies. The senior director will ensure a strong focus on competencies… more
    HireLifeScience (03/01/24)
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  • Eisai, Inc (NJ)
    …provider business relationships in alignment with global strategies.Review and approve Clinical Quality Assurance audit plans and reports.Review and respond ... advanced degree.Minimum 7-10 years procurement experience, minimum 7 years pharmaceutical/ clinical outsourcing.In-depth understanding of GCP /GLP guidelines, audit… more
    HireLifeScience (02/01/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …regulatory authority) in relation to the design, planning & conduct of GCP clinical trials Excellent communications skills (verbal, written, presentation) in ... development/trials Experience leading cross-functional teams in the execution of clinical trial portfolios/programs preferred Expert in ICH- GCP principles and… more
    HireLifeScience (03/27/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    … programs.Help to ensure in collaboration with Global Development Operations (GDO) (Global Clinical Operations / Clinical Quality Management or other RD ... Quality professionals at strategic project team and at GCP strategic discussions.Support the Head of RD QA with...and reviewing quality metrics for the Quarterly Quality Report (QQR) and Clinical Quality more
    HireLifeScience (02/24/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …A minimum of 2 years prior training experience preferred Advanced knowledge of Good Clinical Practice ( GCP ), ICH Guidelines, federal and local regulations, and ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
    HireLifeScience (03/28/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …training facilitation, application of adult learning principles, etc. Knowledge of Good Clinical Practice ( GCP ), ICH Guidelines, federal and local regulations, ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
    HireLifeScience (03/28/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …reporting (AR) for investigational and post-marketed medicinal products within the Clinical Safety and Pharmacovigilance (CSPV) department. Since a global vendor has ... Drug administration (FDA) and other applicable regulatory requirements, Good Clinical Practices (GCPs) and standard operating procedures (SOPs). Additionally,… more
    HireLifeScience (03/15/24)
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  • Good Clinical Practice ( GCP

    GE HealthCare (Boston, MA)
    **Job Description Summary** The Good Clinical Practice ( GCP ) Senior Quality Assurance (QA) Auditor is crucial in ensuring that clinical trials are ... + Training and Education: They may provide training to clinical trial personnel on GCP requirements, SOPs,...system (QMS) improvements. + Overall, the role of a GCP Quality Assurance Auditor is multifaceted, requiring… more
    GE HealthCare (02/23/24)
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  • Senior Manager GCP Compliance

    Takeda Pharmaceuticals (Washington, DC)
    …for projects to address risks and issues + Develop and leadcompliance assessments to address GCP Quality Plan CAPAs/ECs and liaise with QA to ensure adherence to ... **Job Description** **_OBJECTIVES/PURPOSE_** + Lead compliance management efforts related to quality events and auditsfor clinical trial deliveryfunctions to… more
    Takeda Pharmaceuticals (01/17/24)
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  • Director GCP & GVP Quality : Job ID

    Ascendis Pharma (Palo Alto, CA)
    …oversight of the compliance, quality , standards and training within the Good Clinical Practice and Pharmacovigilance ( GCP /GVP) areas, with an emphasis on ... and audit program in assuring quality risk management/mitigation, including performing GCP audits of internal processes, vendors and clinical trial sites. +… more
    Ascendis Pharma (03/25/24)
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  • Clinical Oversight Lead II/ Senior

    United Therapeutics (Durham, NC)
    …Excellent understanding of the clinical research process, including US FDA, EU, and GCP regulations, and the function of quality control in clinical ... oversight of sites, vendors, and United Therapeutics staff responsible for conducting clinical trial activities. Compile and report quality metrics, building… more
    United Therapeutics (01/31/24)
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  • Clinical Research Senior Coordinator

    University of Colorado (Aurora, CO)
    Clinical Research Support Team (CReST) has an opening for a full-time Senior Clinical Research Coordinator to provide regulatory, study coordination, and data ... Clinical Research Senior Coordinator - 28335...(SOPs), and research standards and best practices (ICH Good Clinical Practice ( GCP ), and Good Documentation Practices… more
    University of Colorado (03/09/24)
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  • Senior Clinical Trial Manager…

    IQVIA (Durham, NC)
    Job Overview Senior Clinical Leads are an integral part of clinical trial delivery, leading and working alongside clinical teams to improve patients' ... by bringing new drugs to the market faster. The Senior Clinical Lead is a member of...clinical risks through the project lifecycle. * Ensure clinical quality delivery by identifying quality more
    IQVIA (03/22/24)
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  • Research Services Senior Pro-…

    University of Colorado (Aurora, CO)
    Research Services Senior Pro- Clinical Sciences - 29439 University Staff **Description** **University of Colorado Anschutz Medical Campus** **Department: ... Dermatology** **Job Title: Research Services Senior Pro- Clinical Sciences** **Position: # 00807887- Requisition:... research, such as understanding federal regulations and Good Clinical Practice ( GCP ) **Knowledge, Skills, and Abilities:**… more
    University of Colorado (01/17/24)
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  • Senior Manager Clinical Operations

    Teva Pharmaceuticals (West Chester, PA)
    …other study managers and other GCO staff responsible for the timely execution of high- quality clinical studies within budget and according to SOPs. + Foster a ... Senior Manager Clinical Operations Date: Mar... Senior Manager Clinical Operations Date: Mar 5, 2024 Location: West...GCO functions like DM, CSC + Ensure compliance with Quality standards (SOPs, GCP , etc.). + Manage… more
    Teva Pharmaceuticals (03/07/24)
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  • Senior Director Clinical Trials…

    e CancerCare (Fresno, CA)
    …Assures compliance with all regulatory requirements and standards of good practice ( GCP ) related to the conduct of clinical research. Responsibilities/Essential ... staff, subIs, and PIs complete and maintain appropriate certifications specific to clinical trial participation ( GCP , Conflict of Interest, FDA Focused, and… more
    e CancerCare (02/16/24)
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  • Clinical Research Associate III-…

    WuXi AppTec (Austin, TX)
    …be made and every disease can be treated." **Responsibilities** **Job Summary:** The Senior Clinical Research Associate is a critical position within the ... and is assigned as a study lead to manage clinical trial studies. The Senior CRA will...+ Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and… more
    WuXi AppTec (01/16/24)
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  • Senior Clinical Trial Coordinator

    J&J Family of Companies (Washington, DC)
    Senior Clinical Trial Coordinator - 2406177877W **Description** Abiomed, part of Johnson & Johnson's MedTech is recruiting for a Senior Clinical Trial ... impact health for humanity. Learn more at https://www.jnj.com/. The Senior Clinical Trial Coordinator (Sr. CTC) supports...an Investigator Site, Sponsor or CRO + Knowledge of clinical trial operations, ICH- GCP Guidelines and other… more
    J&J Family of Companies (03/26/24)
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