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As lead of the Study Core Team the CS will lead via a matrix organization Epidemiology, Biostats, Clinical Operations, Medical/Scientific Affairs, Regional, Pfizer laboratory assay group, and external team members.
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Liaise directly with internal customers (Biometrics, Clinical Operations, Safety/Pharmacovigilance, Regulatory Affairs, etc.) Strong knowledge with CDISC (CDASH/SDTM), medical dictionary coding standards, FDA and ICH guidelines, GCP, 21 CFR Part 11, Clinical Data Management best practices.
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The Clinical Affairs Specialist, MCS augments the sales process for the Teleflex Intra-Aortic Balloon Pump (IABP) by partnering with sales representatives and the current or intended customer to drive the clinical aspects of product evaluations, installations, and post-installation training needs to advance and/or maintain stages within the product adoption cycle.
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A thorough understanding of global drug development functional areas including preclinical, clinical, regulatory affairs and manufacturing. Knowledge of GLP/GCLP and GCP global regulatory requirements for clinical trial submissions (USA, UK & EU), understanding of 21CFR Pt. 11 with respect to clinical systems (QMS.
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Serving as a field resource for The Medical Affairs Company (TMAC), the Clinical Trial Liaison (CTL), reporting as Early Clinical Liaison , will represent the Company’s Respiratory Clinical Development program.
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Collaborate and enhance partnerships with all departments to obtain optimal GPvP and PDMA education, training, compliance, and inspection readiness (i.e. Pre-Clinical, Clinical Development, Drug Safety, Medical Affairs, Regulatory Affairs and Commercial Operations.
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Provides administrative support for the Associate Dean for Academic Affairs & Director of Clinical Affiliations. Provide support to Associate Dean for Academic Affairs and Director of Clinical Affiliations, as directed.
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Relationships Reports to the Senior Director, Clinical Pharmacology for the U.S. East Coast Hub. Will interact with Medical Specialists, Clinical Operations, Medical writing, Regulatory, Data Science (statistics, pharmacometrics), Research and Early Development, Global Translation, Global Medical Affairs, Global Safety (GS), Bioanalysis, CMC and occasionally with leadership in Medical and Science.
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Collaborate with internal stakeholders (clinical operations, regulatory affairs, quality, CMC, etc.) PepGen Inc. is a clinical-stage biotechnology company advancing the next-generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases.
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ResponsibilitiesThe Assistant Dean of Clinical Affairs for the School of Nursing will work with the healthcare clinical facilities located in the Northeastern University Network to include the Boston, Burlington, and Charlotte campuses as well as those affiliated with our satellite programs to establish and maintain sites for student placements in clinical and practice settings at the prelicensure and graduate levels.
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Departments include senior management, regulatory, QA, CMC, program management, finance, business development, medical affairs, clinical development and medical writing.) Founded by an internationally recognized team of neurodegenerative biologists from Harvard Medical School and Harvard University, QurAlis is a clinical-stage biotechnology company advancing a pipeline with therapeutic candidates that target specific components of ALS and FTD pathology and defined patient populations based on both disease-causing genetic mutation(s) and clinical biomarkers.
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This role includes the management and oversight of the planning, forecasting, packaging, labeling, distribution and return of clinical supplies for assigned clinical trials and collaborates closely with the broader CMC and Supply Chain Management team, as well as with key internal stakeholders such as Clinical Operations, Regulatory Affairs and Quality Assurance.
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Act as the primary point of contact for cross-functional teams, including clinical operations, regulatory affairs, pharmacovigilance, and data management. Lead, manage, and oversee all aspects of early-phase (I/II) clinical trials, with a focus on rare disease therapeutic areas.
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Collaborate with CMC, Program & Portfolio Management, Clinical, and Regulatory Affairs to develop program-specific strategies for appropriate data generation in support of development candidate nomination, IND filing, and clinical development of biologics.
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Practices four handed dentistry, prepares operatories for the required procedures, provides clinical support to students and Group Leaders and providing customer service through strong interpersonal skills.
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affairs job Title: clinical in Watertown, MA
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