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You will serve as the primary pharmacovigilance lead on study teams and liaise with cross functional team members, as well as external vendors and services providers; performing drug safety study start-up, maintenance, and close-out activities.
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They are seeking a Clinical Research Scientist (up to Sr./Director level) with a strong scientific background in Oncology, Immunology, or Immuno-oncology. Responsible for scientific leadership and execution of clinical studies and delivering on innovative clinical study designs, high quality trial execution, investigator engagement, data review, safety assessment, and interpretation of clinical study results.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Review preclinical study reports, in conjunction with Pharmacokinetics/DMPK and prepare regulatory submission documentation. Solid understanding of drug metabolism, bioanalysis, pharmacokinetics, preclinical pharmacology, PK/PD modeling and clinical study designs.
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Conduct internal audits to assess effectiveness of Entrada's GCP/GLP QMS and process compliance including Clinical Study Report (CSR) and Trial Master File (TMF) audits. Lead qualification, routine and for-cause audits of Clinical Research Organizations (CRO), investigator sites, laboratory and data management vendors as well as other clinical vendors to assess effectiveness of their QMS and compliance to approved clinical study protocols and contracts.
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CIEE is a non-profit study abroad and intercultural exchange organization that transforms lives and builds bridges between individuals and nations through study abroad and international exchange experiences that help people develop skills for living in a globally interdependent and culturally diverse world.
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Contribute to safety sections of clinical study documents including Study Protocols, Informed Consent Forms (ICF), Statistical Analysis Plans (SAP), IB Reference Safety Information (RSI), Clinical Study Reports (CSR), Summary of Clinical Safety (SCS), Integrated Clinical Safety (ICS), Publications, and other relevant documents.
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The individual recruited for this new role will serve as a resident genomic assay expert, whose role includes working within clinical study teams on effecting genomics-based biomarker assays/technologies into oncology Phase 1-3 clinical trials.
$143,500 - $205,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The ideal candidate will be an externally recognized and well respected expert in Clinical Pharmacology, population PK, pharmacometrics, and/or DMPK and have extensive experience applying innovative pharmacology approaches to IND filings, first in human dose prediction, drug development, dose recommendations for clinical studies, study design, dose decisions and health authority interactions.
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Review development documents such as clinical protocols, clinical study reports, preclinical study reports, and CMC documents. Under the direction of the Vice President of Regulatory Affairs, the Director, Regulatory Affairs will work collaboratively with internal team members and external contractors to provide regulatory direction and ensure compliance with the development of oncology products.
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The Lead Data Manager will report to the Senior Director of Data Management and will work closely with all other functional groups that comprise the Clinical Study Team. Perform ongoing review of study documentation in the trial master file (TMF) to always ensure audit readiness.
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The Harvard Law School Program on Biblical Law and Christian Legal Studies offers students the opportunity to integrate law, leadership, and life through the study, debate, and application of the teaching of the Bible.
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Integration of machine learning and genomics to predict outcomes for newly diagnosed, relapsed and refractory mature T-cell and NK-cell neoplasms: a global study of the PETAL. 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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Known for its ground-breaking technological innovations, Medidata has supported more than 30,000 clinical trials and 9 million study participants. The Senior Director of Product Management directs a comprehensive evidence generation product strategy from product and initiative conception and definition through end of life.
ExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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Support BD/Sales team to engage with the potential clients for their project planning as either project manager or study director. Biocytogen Boston in vivo Team is seeking a talented, enthusiastic, highly motivated in vivo Pharmacologist to execute relevant disease models to support preclinical research services for biotech or pharma companies.
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Managing the technical assistant/associate director(s), psychometrician(s) and research specialist(s), as well as statistical programming at the TIMSS and PIRLS International Study Center.
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study director jobs Company: Genoskin in Boston, MA
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