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Ensure the ongoing completeness of the electronic Trial Master File (eTMF) The Clinical Trial Manager (CTM) is accountable for delivery of selected and/or regional deliverables within a trial (e.g., manage and oversee vendor deliverables, collaborate with functions to set up activities [e.g., Calyx, IRT, eRT], support site activation and recruitment, support data review/cleaning activities, support PI/ICF development.
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Oversee, prepare, and/or review aggregate safety review documents (e.g., Development Safety Update Reports [DSUR], Periodic Benefit-Risk Evaluation Reports [PBRER]) and safety sections of relevant clinical trial documents (e.g., protocols, clinical study reports [CSR], investigator brochures [IB], informed consent forms [ICF]) and regulatory filings (e.g., clinical trial applications [CTA], marketing authorization applications [MAA.
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Extensive knowledge of a broad array of systems including Clinical Trials Management System (CTMS); Risk Based Monitoring (RBM); Electronic Trial Master File (eTMF); Electronic Data Capture (EDC); Clinical Studies Operational Data Warehouse & Analytics; Site Training and Resource Management etc.
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Your role will involve applying state-of-the-art AI techniques to extract valuable insights from various image modalities such as OCT (optical coherence tomography), FAF (fundus auto-fluorescence), and CFP (color fundus photography) in diseases such as dry AMD and IRDs. Through the use of these innovative technologies, you will improve our understanding of structural biomarkers during disease progression, ultimately enhancing clinical trial efficacy and efficiency.
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Strong tactical familiarity with the design, overseeing and assessment of clinical trials and with other medical affairs activities (expertise in clinical trial methodology and conduct, GCP principles, medical product support activities, publications, ISS, continuing medical education.
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Position Summary / ObjectiveThe Senior Manager, GRS-CMC is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating / leading HA meetings); &/or post-approval submissions.
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Required Qualifications: Bachelor’s degree in Engineering, Chemistry, Biology, or related Science 2-5 years of related experience in pharmaceutical/medical device industry in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Product/Clinical Trial Material Ability to work independently.
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Assists in weight management policies and weight certification programs, including assisting the Clinical Sports Dietitian with direct collaboration between UHS and Athletics staff, for all weight class sports (lightweight rowing and wrestling.
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Bachelor's degree in a Chemical or Biological science, Clinical Laboratory Science, Medical Technology or meet local regulatory (CLIA & State) requirements. Minimum 1 year of clinical laboratory testing experience is required OR an MLS degree.
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QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine.
$183,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Expertise in IBM FileNet suits of products such as IBM Content Manager, IBM Case Manager, IBM Content Navigator, CMIS, IBM Content Collector for file systems and emails. Expertise in IBM FileNet suits of products such as IBM Content Manager, IBM Case Manager, IBM Content Navigator, CMIS, IBM Content Collector for file systems and emails.
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As the Nurse Director Hospice Palliative Care, you will work in collaboration with other clinical Directors on team development, strategy, data analyzation, monitoring growth of program, and implementing adjustments and changes to remain consistent with organizational goals and community needs.
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This includes overseeing the daily global eTMF system related activities relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness and compliance with applicable laws and regulations.
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Actively looking for a Senior Scientist, Cell Therapy Process Development contributing to the development of early and late stage clinical cell therapy manufacturing processes. The ideal candidate for this position should have work experience in cell therapy process development, manufacturing science, analytical development, and familiarity with GMP/FDA/ICH guidelines.
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Experience with common equipment used in cell therapy manufacturing such as Sepax, Lovo, G-Rex, Xuri Bioreactors, CliniMACs Plus, CliniMACS Prodigy, MaxCyte GT. Support client facing activities for the cell therapy process development team.
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clinical trial file jobs Title: trial master in Belle Mead, NJ
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