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Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Independently plan and conduct hands-on analyses, including NCA, population PK and PK/PD analyses, exposure-response analyses, clinical trial simulation using a variety of software tools to answer development questions and to inform clinical development strategy.
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The Clinical Trial Associate (CTA) supports the Clinical Operations, Supply and Data Management department in the planning, execution, and management of clinical trials. Collect, file, and track clinical trial associated study and regulatory documents for the Trial Master Files.
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Contributes to and serves as medical point of expertise in key Health Authority interactions and advisory board meetings as Senior Clinical Trial Physician. Identifies and cultivates thought leaders in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs.
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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modelling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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Overview Working in a fast-paced, high volume, dynamic environment, the Clinical Authorization Specialist will bring clinical expertise to the prior authorization and appeals processes and serve as a liaison and patient advocate between Dana Farber Cancer Institute and various health plans.
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Plan, conduct, and lead complex clinical study audits (Sponsor, Investigator Sites and Clinical Suppliers) (either remote or on site) in accordance with all applicable regulations, standards, guidance, and the established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
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Reporting to the Vice President of Clinical Operations, the Trial Master File (TMF) Associate Director / Director serves a key role, working across the organization for the execution of TMF Operations processes and strategy.
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Job Title: Environmental Health and Safety Specialist II (Onsite)
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Ensures TMF/eTMF is FDinspection ready at all times while the clinical trial is being conducted. Knowledge of the Pharmaceutical Industry Clinical trial process (clinical trial conduct, documentation and reporting) in accordance with ICH/GCP and other regulatory compliance guidelines.
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General Summary/Overview StatementThe Mass General Brigham (MGB) Digital Epic Platform Architect/Clinical Informatics Lead for Procedural Specialties is responsible for providing leadership and oversight of the build and maintenance of the procedural Epic applications including (but not limited to) Radiant, Cupid and OpTime/Anesthesia.
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Expertise in clinical trial documentation and TMF Reference Model filing structure and proficient in eTMF systems or other Electronic Document Management System (familiarity with the Kivo system is a plus.
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For more information about Leap Therapeutics, please visit. Lead cross-functional teams comprised of members from diverse subject areas – including, but not limited to - clinical operations, medical, regulatory affairs, biometrics, safety, quality, and supply – to facilitate transparent communication and knowledge sharing.
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When you join RadNet as a Clinical Applications Specialist , you will be joining a dedicated team of professionals who deliver quality, value, and access in the 21 st century and align all stakeholders- patients, providers, payors, and regulators achieve the best clinical outcomes.
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Position Summary:The position reports functionally to the Vice President Human Resources, CDD and supports the division functions as well as the GM of Clinical Diagnostics Reagent and the Diagnostic Services commercial team.
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Provide medical and scientific support for the development and implementation of cell therapy studies, including protocol development, electronic data capture database development, safety assessment, IB/DSUR submissions, and clinical data review with a focus on the specificities of cell and gene therapy.
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Title: clinical trial Company: Leap Therapeutics in Lexington, MA
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