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Demonstrate expert understanding of the federal and institutional regulations and policies governing clinical research involving protection of human subjects (JCAHO, FDA, ICH, GCP, OHRP, IRB, NIH.
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Additional Skills (preferred): Good Clinical Practice (GCP), Human Subjects Training, and International Air Transportation Association (IATA) certification for shipping hazardous and biological substances.
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PDS works with customers to develop new methods, validate existing methods, as well as performing the assays necessary to analyze samples from patients on more than 100 clinical trials currently in different phases of the FDA regulated drug approval process.
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Our expert scientists perform large molecule bioanalysis, assay development, validation, and sample analysis at our GLP, GCP, and CLIA compliant laboratories. Smithers PDS LLC (Pharmaceutical Development Services) assists in the development of new medicines by providing bioanalytical services for all phases of drug development from discovery through approval and post market surveillance.
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Proactively manages, coordinates, and delivers high-quality, compassionate hands-on competent oncology nursing care and coordinates with the assigned clinical team, investigators, and ancillary departments (such as pathology, radiology, clinical laboratory, surgery, infusion services) as per protocol requirements and ensures adherence to the treatment plan and GCP guidelines.
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Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics.
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In particular this will include developing and maintaining a deep knowledge of Good Clinical Practice (GCP) with respect to digital data management (i.e. use of novel technology within clinical trials.
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Maintain current regulatory inspection knowledge as it relates to Good Clinical Practice (GCP) inspections by regulatory agencies worldwide, especially those conducted by key authorities such as the USA Food and Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency, as well as other established and emerging authorities.
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Develop, update, and maintain GCP inspection procedures and guidelines within Global Clinical Trial Operations (GCTO). We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.
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Overseeing the strategic implementation of quality by design principles in assigned clinical trials. It is business critical that our Company receives consistent, accurate, high-quality data from clinical trials conducted worldwide.
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The position will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed quality into our Company sponsored trials, ensure adequate vendor oversight and address any quality issues as needed.
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Provide input into GCP Quality and Compliance Council regarding the QMS, RACT, Quality Plans and Regulatory Health Authority inspections status and results, including escalation of overdue CAPA commitments.
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Ensures that a cross-functional team (e.g. Quality & Continuous Improvement (QCI) colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.
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The Clinical QA Manager will be responsible for the development, maintenance and oversight of the GCP activities related to clinical trials. Battery Bio harnesses Vial's unique 90% lower cost structure to produce more affordable drug development with efficient, streamlined clinical trials.
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Ensure the smooth running of the clinical research program team including that colleagues are updated on all relevant issues, develops systems to track multiple projects including all regulatory files, investigator and IRB information, patient recruitment activity and financial management as well as ensuring high data quality across all clinical trials.
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