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Ensures all appropriate strategic CMC regulatory aspects for clinical trials, product release and stability are in place, to avoid clinical holds, and to ensure continuity of market supply.
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Reviews SOPs, policies, change controls, corrective and preventative action plans, and engraftment/outcome data related to clinical trials and investigational products along with the research RN and compliance officer.
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Our office promotes and facilitates clinical research by providing comprehensive services to physicians conducting clinical trials while ensuring compliance with all regulatory requirements.
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Job Overview: This position is well-suited for a Medical Director with substantial expertise in drug development and safety, providing a unique opportunity to strategize the implementation of safety surveillance for clinical trials, oversee the management of safety signals, take charge of cross-functional teams, and contribute to the development of regulatory safety deliverables.
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Clinical pharmacokinetics, clinical pharmacology, clinical trials, clinical drug development, scientific leadership, associate director, drug discovery, pharmacodynamics, bioanalysis.
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The Coordinating Center Senior Project Manager for the Center for Clinical Investigation Coordinating Center (CCI-CC) will report to and work closely with the CCI-CC Director in the development, implementation, and management of the clinical trial operations for ongoing clinical trials and research consortiums.
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Serve as the SME for important toxicology/Safety topics in areas such as safety biomarker analysis, genetic, endocrine, reproductive toxicology, applications of scientific methods to delineate appropriate mode-of-actions on emerging safety issues and the assessment of human relevance of the nonclinical findings in support of the planned and ongoing clinical trials.
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Manages the DFCI Biosafety Communications Program by identifying topics relevant to investigators with biosafety protocols such as upcoming modifications to IRIS for human gene therapy clinical trials and iRIS-IBC for laboratory registrations and any regulatory and DFCI policy updates, training requirements, resources and guidance, and those requested by the Director of Biosafety.
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Comprehensive knowledge of Good Clinical Practice (GCP) guidelines, regulatory requirements, and industry best practices related to clinical operations, gene therapy development, and pediatric oncology studies.
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Experience with conduct of clinical research with pharmaceutical/device clinical trials and/or observational or social behavioral and/or public health research. The Clinical Research Resources Office (CRRO) Regulatory Education Manager will manage two important aspects of the HRPP: the Research Professionals Network (RPN) and the human/clinical research education and training for Boston University and Boston Medical Center researchers (PIs and study staff.
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Independently manage interactions with clinical monitors, data management, safety, regulatory, pharmaceutical science and QA team members, both internally and externally. Experience in rare disease, pediatric, and/or complex clinical trials preferred.
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Strong knowledge of CDISC standards (SDTM, ADaM) and regulatory requirements for clinical trials. Lead and manage the statistical programming activities for clinical trials and studies, ensuring high-quality deliverables and adherence to timelines.
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TMF plays a critical role in ensuring the completeness and accuracy of the TMF for all BioNTech-sponsored clinical trials. Provide a robust framework to evaluate the overall health of the TMF, ensuring quality, completeness, and timeliness in the TMF for all BNT-sponsored clinical trials, driving a culture of compliance and quality.
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NCH is transforming into an Advanced Community Healthcare System(TM) and we’re proud to: Provide higher acuity care and Centers of Excellence; Offer Graduate Medical Education and fellowships; Have endowed chairs; Conduct research and participate in national clinical trials; and partner with other health market leaders, like Hospital for Special Surgery, Encompass, and ProScan.
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Author or oversee the development of statistical analysis plans for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE), and oversee the development of shells for tables, figures, and listings.
$216,000 - $270,000 a yearFull-timeExpandApply NowActive JobUpdated Today
clinical trials regulatory jobs in Cambridge, MA
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