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Extensive knowledge and application of current FDA Regulations, ICH/GCP guidelines in clinical trials. Lead and manage day-to-day execution of assigned clinical trials to ensure all trial deliverables are met according to established timelines, goals, budget, and quality standards.
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The Senior Manager of Supply Chain has the responsibility of managing the supply of investigational product(s) (IP) for early and late-stage clinical trials as well as aid in commercial supply chain activities.
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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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Familiarity with ICH-GCP guidelines, FDA regulations, and other applicable regulatory requirements governing clinical trials. Collaborate with the clinical trial team to develop and implement operational plans for clinical trials, adhering to Good Clinical Practice (GCP) guidelines, relevant regulations, SOPs, and study protocols.
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Oversees all phases of pre-award grant and contract administration (NIH, industry and foundation grants, sundry funds, clinical trials, etc.) Provides Just-in-Time documentation and evidence of compliance, including Human Subjects Research (IRB) and Vertebrate Animal Research (IACUC) protocol approvals, Other Support pages, salary confirmations, and other information as needed.
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We are seeking a Clinical Trial Associate (CTA) to assist and provide support to the members of the clinical operations project team in order to facilitate the management of the clinical trial processes, including planning and execution of clinical trials.
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Clinical Development: Lead the planning, design, and execution of clinical trials. Experience in both big pharma (e.g., AZ, BMS, Roche) and biotechnology companies. Medical Expertise: Stay current with oncology advancements and provide medical insights to internal and external stakeholders, including preclinical teams, regulatory affairs, clinical operations, and business development.
$280,000 - $360,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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In tandem with the Cancer Center Protocol Office and the Research Manager, RNs participate in the administration of all phases of clinical trials in which their primary patients may be enrolled.
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The Clinical Trial Manager, Site Start-up will lead internal process improvements related to study start up activities to ensure clinical trials are executed with high quality standards in compliance with regulatory requirements, GCP, and company SOPs. This role is based in our Waltham, MA headquarters.
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Collaborate with cross-functional teams (including Clinical Operations, Biostatistics Regulatory Affairs, Patient Safety, and Pharmacology/Pharmacometrics) to design and implement clinical trials.
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This person will also work with key functions for the expansion of products into other trials and indications, if applicable, and potentially lay the groundwork for other programs as they enter the clinic.
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Regulatory Knowledge: Determine the candidate's understanding of relevant regulations and guidelines governing clinical trials, such as GCP, ICH, and FDA regulations. BA/BS required; Minimum of 8 years experience in a health care and/or clinical research setting, including exposure to pharma services (e.g. CROs or analytics) in Real World Evidence.
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Purpose of the role:Senior Manager, PV Scientist of Pharmacovigilance's main role is to ensure the process and evaluation of adverse events (AEs) received from clinical trials and/or post marketing sources to support drug development, postmarketing requirements and to monitor the safety and efficacy of products.
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Conduct in-person meetings with surgeons and support staff to discuss AtriCure technology, training programs, clinical trials, and more. AtriCure’s Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure’s AtriClip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide.
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The Key Account Executive, Clinical Trials is a remote field sales role in our Abbott Point of Care Division and will prospect and drive sales for assigned accounts within the clinical trials industry as well as lead thought-provoking discussions to challenge the status quo and provide innovative solutions that address our clients’ key business challenges.
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trials job in South Boston, MA
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