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Solid working knowledge of Pharmacokinetics, PK/PD principles applied to modeling, ADME and clinical pharmacology concept and understanding of regulatory guidelines on DMPK/ clinical pharmacology studies to support early oncology drug development.
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Strong familiarization with Good Clinical Practice (GCP) and drug development processes, ideally Phase 1 – 3; ideally paired with experience in Oncology / Immuno-Oncology. Perform high quality clinical data review and identify clinical data insights through ongoing patient level review and trends analysis, thereby supporting for example Interim Analysis, Database and Post Lock activities and resolution of scientific & medical issues throughout the study lifecycle.
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The Clinical Sales Specialist (CSS) - Ophthalmology will provide technical sales support for all Medical products. Clinical Sales Specialist - Ophthalmology. Leica Microsystems is one of the market leaders in the fields of microscopy, imaging, and analysis.
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In this new role, you will manage clinical trial(s) under the leadership of the VP, Clinical Operations clinical development team. You will manage clinical trials from start-up through close-out to ensure both internal and external deliverables are on time and on budget while facilitating collaboration across functional areas.
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This could include licensure as a Licensed Marriage and Family Therapist (LMFT), Independent Licensed Clinical Social Worker (LICSW), or a Licensed Mental Health Counselor(LMHC). An active clinical license within the Commonwealth of Massachusetts is required.
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Reporting to the VP, Head of Clinical Operations you will be responsible for supporting the critical day-to-day clinical study activities, including development of study start-up materials, clinical supplies, case report forms, contracts and budgets, investigator meetings, and regulatory document filings.
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Clinic Research Coordinator II The Clinical Research Coordinator II , will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor.
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Serve as part of the multidisciplinary review team to complete utilization review of client records and implement corrective actions for all clinical documentation in order to maintain agency compliance with state regulations and mental health professional standards.
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In this exciting role as the Senior Field Clinical Research Specialist, you will be responsible for clinical trial site management, case coverage, and clinical trial data tracking.
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Experience with and demonstrated ability to lead and manage trained medical, scientific and technical professionalsKnowledgeEmerging research in Translational MedicineNonclinical and clinical drug discovery and developmentTMS state-of-the-art technologiesRegional/global Regulatory requirementsGCP/ICHTakeda Compensation and Benefits SummaryWe understand compensation is an important factor as you consider the next step in your career.
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Can proficiently perform all duties of an LTA. Performs other clinical laboratory assistant duties and responsibilities as required at the direction of lab support supervisor. Qualifications Minimum Education/Experience: High School Diploma or EquivalentGraduate of Phlebotomy Training program preferred.
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Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.
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The Associate Director/Senior Manager of Clinical Quality will develop, manage, and improve existing quality systems to ensure appropriate controls for EyePoint in-house GCP and GLP capabilities.
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Experienced Clinical Research Associates- a ccelerate your hematology/oncology career by joining Medpace today! Candidates must have at minimum a Bachelor's degree in a health or science related field, minimum one year of clinical research experience or relevant direct industry experience (e.g., CRC), ability to travel nationwide, must be detail-oriented, strong time management, and communication skills.
$90,000 - $140,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Provide proactive GCP QA support for clinical development to ensure patient safety, data integrity, compliance, and operational excellence. 5+ years of direct GCP pharmaceutical/biotechnology experience in Clinical Quality Assurance auditing.
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Title: clinical Company: F Hoffmann La Roche in Boston, MA
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