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Supervise clinical staff to ensure all study activities are completed in accordance with applicable regulations and guidance, ICH, GCP and Bausch Health SOPs. Responsible for the quality of all study-related documentation (e.g., Trial Master File, site qualification and initiation visits reports, interim monitoring visit reports, clinical monitoring plan, informed consents, CRF completion guidelines, pharmacy manual, etc.
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Represent QA in study team(s) where relevant and participate as appropriate to ensure clinical trials are conducted in compliance with clinical protocols, GCP and other regulatory requirements.
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As a Digital Biomarker Lead you will be overseeing aspect of sensor-related research, from benchtop experiments to oversight of technical validation in large-scale clinical trials. This innovative position bridges the gap between traditional biomarkers and cutting-edge digital technologies, driving the development and validation of novel digital endpoints for clinical trials.
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This position ensures quality delivery of medical coding for clinical trials, clinical development, and regulatory submissions. Develops and proposes strategies for medical coding and coding dictionary ensuring all clinical trials meets quality requirements and best practices in medical coding.
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Continuously pursue new opportunities that benefit clinical trials and present solutions to internal stakeholders. In collaboration with medical director, Digital Medicine Lead, QS, and others, design study; execute on sensor-facing aspects of CES study, including liaison with vendor/device collaborator and User Experience Research (UXR.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Summary: The Clinical Trial Specialist/In-house CRA provides technical and administrative support to the clinical study team(s) responsible for clinical trial execution. This person receives assignments from the Clinical Study Leader or Clinical Study Associate Manager.
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Support the development of biomarker related aspects of the trial design, study protocols, lab manuals, clinical study reports, investigator brochures and regulatory documents. Six or more years of experience in biomarker development and implementation in oncology clinical trials is required.
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Statistical Programming Management: Coordinates outsourced statistical programming of analysis data sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work.
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Defining and executing strategic roadmaps for: (1) CSU Cluster’s clinical study pipeline, (2) Future of clinical trials including the evolution of the business, (3) Business development with the key Investigators, KOLs and their institutions.
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4 or More Years More than 5 years of experience in imaging operations in oncology clinical development of both early and late phase clinical trials, including development and review of imaging section of the protocol, imaging charter, site manuals, and communication plan.
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Leads or collaborates on required tasks prior to commencement of clinical trials that include, but are not limited to: clinical planning, protocol development, case report form (CRF) development, IRB submissions, investigator agreements, informed consent form (ICF) development, site selection and communication with clinical trial sites regarding all logistics including contract agreements, support materials and training.
$120,000 - $155,000 a yearFull-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Assist in the conduct of clinical trials as specified by the study protocol under the supervision of designated Principal Investigator and departmental management. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations.
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Maintain and prepare for final archival of data management documentation relevant to the assigned clinical trials and assist the corporate archivist in assembling and archiving clinical trial data and study documentation.
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Biostatistician (2 x openings) in Somerset, NJ : Write/review clinical research protocol, SAP and study report for clinical trials projects; develop and validate statistical models and SAS programs for analysis, management and reporting of clinical trials data, generate and validate safety and efficacy TLGs, analysis datasets (SDTM, ADaM) and clinical trial reports.
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The Director, Biostatistics provides technical leadership and operational support for the design and implementation of clinical development programs and the associated clinical trials.
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clinical trials study jobs in Bridgewater, NJ
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