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Serve as the subject matter expert on Veeva Vault and related clinical trial management systems (CTMS), electronic trial master file (eTMF), and regulatory document management systems.
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Manage set-up, maintenance, closeout and archiving of the Trial Master File (TMF), ensuring inspection readiness. Minimum of 5 years clinical trial experience, of which at least 2 years are in global study management United States only.
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Upload biospecimen-related documents to the Trial Master File, ensuring that documentation standards are followed and are ‘inspection-ready’. Perform continuous tracking of clinical trial collected biospecimens and related logistics, issues and queries from the planning stage to final disposition.
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Bachelor’s Degree in a related field and 9+ years of related work experience (including data analytics, data management, health economics, medical affairs, clinical risk, clinical trial operations, clinical safety, quality assurance or regulatory affairs) or advanced degree (PhD, research-based MS, MD, RN/DVM) in a related field with 7+ years of related work experience.
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Manage and provide oversight to the CDM section of the Trial Master File. Reporting to the Executive Director, CDM, the Senior Manager, CDM will be a highly motivated, quality-focused individual who can work collaboratively in a fast-paced, cross-functional team environment, and will oversee data management activities across multiple studies from study start-up through study closure in support of clinical trial objectives and corporate goals.
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Maintain and perform ongoing quality review of trial documents within the Trial Master File (TMF); This position works both independently and collaboratively with a team to meet common goals and plays a key role in the clinical trial management and study start-up process at Medpace.
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The Clinical Trial Rater will administer semi-structured test or rater scales as per protocol, not limited to CDR, ADAS-COG, MMSE, CSSRS, Cognitive Battery Test, ESS, and like exams. The Clinical Trial Rater, a mental health professional, will be solely responsible for interviewing research participants and their informants/caregivers who are being evaluated to participate in a research study for various cognitive and behavior disorders.
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The Community Practice Clinical Data Coordinator at Trial Library will play an integral part in expanding access to cancer clinical trials by pioneering pre-screening efforts in community oncology settings.
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Uploads documents to the Trial Master File (TMF). The Senior Regulatory Operations Associate provides trial support to the Regulatory Operations team and Regulatory Affairs and Investigator Services department, thereby contributing to the overall management of clinical trials in accordance with applicable regulatory guidelines/requirements, Tempus Compass Standard Operating Procedures (SOPs) and project specific plans.
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Ensure the ongoing completeness of the electronic Trial Master File (eTMF) The Sr Clinical Trial Manager is accountable for delivery of selected and/or regional activities within a trial (e.g., manage and oversee vendor deliverables, collaborate with functions to set up activities [e.g. DM, IRT, eRT], support site activation and recruitment, support data review/cleaning activities, support PI/ICF development.
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Ensures study compliance with OPUS SOPs and regulatory guidelines by performing periodic quality control audits of any trial master file (TMF) maintained by the Service Provider (SP) before study initiation, during and at the end of a study.
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Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews. 4DMT is recruiting for a motivated and experienced Sr. Clinical Trial Manager to support the Company's clinical trial activities.
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Reporting to the SVP, Head of Clinical Safety & Postmarketing Pharmacovigilance, the Executive Director, Postmarketing Pharmacovigilance & Compliance will play a key role in management of the Pharmacovigilance System Master File (PSMF), including Compliance and Inspection-readiness activities.
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Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) through the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA.
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Requirements: MINIMUM QUALIFICATIONS A Master's Degree in Audiology;Minimum three years of clinical experience with Audiological Evaluations, Hearing Aid Dispensing; assessment across the age range;Current ASHA Certificate of Clinical Competence in Audiology (ASHA CCC-A);Be eligible for NYS licensure in Audiology and Hearing Aid Dispenser license;Be eligible for enrollment with major third-party insurances, Medicare and Advantage Plans.
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clinical trial master file jobs Title: clinical manager contract
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