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Thus, the candidate should also have an understanding of various clinical trial activities such as Clinical Trial Management Services, clinical monitoring, data management, Real World Data/Evidence (RWD/RWE), biostatistics, medical writing, Ph 1 CRU, central lab, biomarker lab, bioanalytical lab, RTSM, eCOA, medical imaging, safety, e-informed consent, mobile HCP services, telemedicine and wearables/sensors.
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Knowledge of the drug development process, Good Clinical Practices (GCP) and Good Pharmacovigilance (GVP), including worldwide PV regulations and their application to safety science activities (aggregate PV reports, risk management plans, signal detection, clinical trials and clinical development.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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This position requires a comprehensive knowledge of SAS and CDISC standards, project and resource management, regulatory filing experience, and a broad understanding of the pharmaceutical drug development process.
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Daily activities will include, but are not limited to, working within a team environment and leading functional internal audits of VO's electronical Trial Master File (eTMF) and Contract Repositories to ensure meticulous oversight of VO's documentations, adherence to work procedures, compliance standards, and the preservation of data integrity.
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Establishes the direction of pharmacovigilance activities for assigned products and provides global medical leadership and input into all aspects of safety of assigned molecules within the Oncology TA including surveillance programs, aggregate review, and risk management planning.
$274,635 - $355,410Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Coordinate building/project commissioning and activation activities with key stakeholders, like the Engineering, Hospital & Clinic Activations (HCA), Environmental Health & Safety (EH&S), Site Support Services (SSS), Technology & Digital Solutions (TDS) departments, into full operations to ensure transfer of knowledge of all systems and ensue readiness of the operations environment to shift to full operations.
$79.15 - $104.87 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Thus, the candidate should also have an understanding of various clinical trial activities such as Clinical Trial Management Services, clinical monitoring, data management, Real World Data/Evidence (RWD/RWE), biostatistics, medical writing, Ph CRU, central lab, biomarker lab, bioanalytical lab, RTSM, eCOA, medical imaging, safety, e-informed consent, mobile HCP services, telemedicine and wearables/sensors.
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Demonstrates a thorough knowledge of Good Clinical Practice "GCP", Good Pharmacovigilance Practices "GVP", Good Laboratory Practice "GLP", Good Documentation Practice "GDP" and ICH E6 R2 compliance requirements.
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The candidate should have a deep understanding of vendor outsourcing's responsibilities throughout the vendor sourcing, contracting, and management processes as they will be reviewing VO's functional responsibilities in support of the clinical development portfolio.
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Candidate has 5 years of relevant experience in the pharmaceutical or biopharmaceutical industry; and, has a BS or BA.(1) PMP certification or equivalent certification, (2) Candidates can be current or former project managers & (3) Project management experience in Pharmaceutical or Healthcare industries.
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Strong knowledge in the following areas: Cloud Security, Identity and Access Management, Application Whitelisting, Threat and Vulnerability Management, Data Loss Prevention, and operating systems security for Windows and Linux environments.
Full-timeExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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Oversee the management of assigned programmatic staff (technically, operationally, and administratively), including planning, and directing the activities of department(s); monitoring activities for timely completion and quality; overseeing staffing, performance evaluation, and staff management; forecasting department or division staffing needs.
Full-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Oversight of the collection and management of clinical trial documentation to be filed in the Trial Master File (TMF). This is a unique opportunity for an experienced Clinical Operations Professional who has technical expertise in managing Phase I-III clinical trials in an industry setting and a strong knowledge of clinical operations, Good Clinical Practice (GCP) and U.S. Food and Drug Administration (FDA) regulatory requirements.
Full-timeExpandApply NowActive JobUpdated 27 days ago - UpvoteDownvoteShare Job
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Pioneer Ct provides Drug MediCal services which includes outreach and engagement, intake/assessment, goal planning, individual and group counseling, crisis support services, social recreational activities and care coordination.
$70,000 - $94,000 a yearExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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The Clinical Trial Manager in the Research Alliances team will oversee the planning, execution, management, and reporting of clinical projects supporting Iovance commercial activities, including expanded access programs (intermediate and single-patient) and Phase 4 post marketing pharmacovigilance studies.
Full-timeExpandApply NowActive JobUpdated 14 days ago
knowledge management activities jobs in Belmont, CA
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