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The Director of the Office of Data Quality will also interact closely with other DF/HCC and DFCI offices that support clinical research including: Clinical Trials Research Informatics Office, Office of Human Research Subjects, Clinical Trials Offices from all DF/HCC consortium sites, and DF/HCC Administration.
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We are using models early to fail less often, executing clinical trials to add valuation to the company, and generating fit-for-purpose data to feed back into Valo’s Opal Computational Platform™ as we reinvent drug discovery and development from the ground up.
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The Clinical Research Nurse is responsible for knowledge of Code of Federal Regulations and Good Clinical Practice, policies and procedures of the Tufts Medical Center/Tufts University Health Sciences Institutional Review Board and all other guidance documents for the conduct of human clinical trials and human research participant protection.
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Reporting directly to the Head of Translational Medicine, this individual will oversee the design of translational/biomarker strategies and collaborate closely with cross-functional teams, including Research, Clinical Development, and Regulatory Affairs, as well as external CROs to ensure their seamless implementation into our clinical trials.
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Coordinate with data management study leads, clinical operations, internal stakeholders and external vendors to map non-EDC data from collection through analysis. The Clinical Data Analyst partners cross functionally to identify risk to data integrity throughout the data flow to drive quality collection for non-EDC data sources (fluid & tissue labs, digital, imaging, wearables) in Dyne's clinical studies.
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Reporting to the Head of Clinical Supply Chain, the Associate Director of Clinical Supply Planning will focus on managing and optimizing global supplies to ensure timely availability of clinical supplies for clinical trials.
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Lead internal and outsourced development and qualification or validation of biomarker assays for clinical trials, applying experience across relevant methods (e.g. qPCR, digital drop PCR, Western blotting), to develop robust assays, generate and analyze data and provide expert interpretation of the effects of promising drug candidates.
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Deep knowledge of immuno-oncology biology, biomarker strategies and application to clinical trials. Oversight and/or development of sample testing plan and delivery of high-quality biomarker data packages to inform clinical development and regulatory strategy.
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Guide and advise clinical development study teams on the design and collection of natural history data to better understand disease progression including risk factors and optimal endpoints for use in clinical trials.
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Join Takeda as a Clinical Biomarker Sample Operations Senior Manager in Cambridge, MA, where you will act as an enterprise level partner responsible for the lifecycle management of clinical bioanalytical (PK, ADA) and biomarker samples, data, and specialty lab vendors to maintain chain-of-custody in a GxP-compliant setting.
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Act as an internal expert in PET/SPECT and Molecular Imaging with focus on clinical trials. Ensure quality and timely execution of imaging trials to deliver critical drug development decisions; be agile and responsive to clinical teams during the course of design, execution and interpretation of imaging trials.
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Building upon the positive results and compelling data from our XEN1101 Phase 2b “X-TOLE” study in adult patients with focal epilepsy, our XEN1101 epilepsy program includes multiple Phase 3 clinical trials in patients with focal onset seizures and primary generalized tonic clonic seizures.
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Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.
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Collaborate with key stakeholders across the organization, including clinical operations, regulatory affairs, data management, and IT, to assess user needs, gather requirements, and develop tailored solutions to address business challenges.
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Master’s degree in data science/bioinformatics/computational biology/machine learning or related field. Support various teams for the processing and interpretation of next-generation sequencing (NGS) data and ensure timely delivery of results.
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clinical trials data jobs Title: operations in Cambridge, MA
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