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Responsible for supporting the management, oversight (CRO) and maintenance of the Trial Master File (TMF) Lead weekly meeting of the Clinical Trial Team on status of assigned studies.
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Maintain quality and compliant documentation related to all aspects of site management including quality and ALCOA+ compliant monitoring visit reports, centralized monitoring reports, site contact reports, Trial Master File/Investigator Site File, etc.
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Collect, file, and track clinical trial associated study and regulatory documents for the Trial Master Files. Maintenance of the Trial Master File and/or electronic Trial Master File (TMF and eTMF) according to ICH-GCP, and company SOPs.
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Oversee the Trial Master File (TMF) and assist with periodic audit of the TMF. Experience with global clinical trial operations, in multiple phases of research. Drive critical clinical trial activities including trial site activations, recruitment, and database lock.
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The Director Trial Master File (TMF) and Clinical Documentation spearheads the vision and strategy for records management of clinical trial documents. Foster effective relationships with stakeholder functions to achieve TMF objectives and serve as a subject matter expert on TMF across all functions involved in clinical trial execution.
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Expert knowledge of clinical trial documentation, TMF Reference Model structure, and clinical trial activities and related terminology. Develop and implement innovative strategies to enhance TMF and other clinical trial documentation systems and processes, leverage technology and ensure seamless operations.
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Will serve as a key strategic partner representing Global CMC Regulatory on Regulatory Networks and Matrix Teams, providing and overseeing strategic direction and guidance to Biopharmaceutical and/or CGT R&D, Pharma Supply Chain, Clinical Trial Supply, Quality Assurance, and Commercial interfaces on both global project and key strategic business initiatives.
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Key responsibilities of Investigators are locating and interviewing persons, obtaining facts, inspecting records, writing reports, documenting crime scenes, searching databases and social media, summonsing witnesses to court, shepherding witnesses through the trial court process, and testifying in court.
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As part of the Clinical Operations organization, and within the Clinical Data Management team, the Associate Director, Clinical Data Management is a critical role to ensuring the highest quality clinical trial data is available to support company objectives and claims.
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Preparation and oversight of Trial Master File (TMF) and internal files, including periodic reviews as per TMF plan. Visterra is seeking a Clinical Trial Manager (CTM) to join our dynamic team.
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The CTM is a key member of the Clinical Operations team and supports the execution and management of clinical trial(s). At least 5 years of clinical research experience at a pharmaceutical/biotech or CRO, with at least two years of clinical study management experience.
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Dir/ Senior Director, Clinical Research Scientist 2020393 Location: Waltham, MA (Hybrid) Therapeutic Area: Immuno-oncology Job Overview: Seeking a Clinical Research Scientist with strong expertise in Oncology, Immunology, or Immuno-oncology to lead the implementation, planning, and execution of clinical trial activities, collaborating with various stakeholders and driving Clinical Development strategy in a fast-paced, collaborative environment.
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The Senior Scientist plays an integral role in the development and hands-on execution of critical projects that support the Heme Translational Medicine Department's aims in translational science, clinical trial support, and pre-clinical drug development.
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Works with Study Start-up and coordinates study start-up activities including feasibility, investigational product and materials preparation, trial master file set- up, CRFs, regulatory documents, and site contracts in conjunction with other relevant departments.
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A PI of the New England Consortium Node of the NIDA Clinical Trials Network (CTN), we are currently leading a major multi-site CTN trial focused on treatment of opioid use disorder. The McLean Hospital Division of Alcohol, Drugs, and Addiction is a highly productive clinical research environment that has led and participated in landmark studies in the field.
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trial file jobs Title: clinical research associate Company: Parexel in Burlington, MA
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