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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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The Clinical Trial Manager, Site Start-up role plays a significant contribution to the clinical trial execution and ability to meet the corporate study goals for the Company clinical 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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Responsible for external outreach with KOLs and key clinical trial sites to provide feedback on study feasibility and study start up activities. Clinical Trial Initiation Manager will deliver high quality and timely global study start-up.
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The Clinical Trial Manager, Site Start-up will serve as an expert in study start-up practices by initiating efficient start-up activities and removing obstacles for study teams. Develop a Site Initiation Management Plan and coordinate regulatory and ethics committee submissions and perform day to day management of the study start up activities for clinical studies.
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You decide when and where you want to work Enjoy industry-leading pay, benefits, and bonuses Experience new people and places Grow your clinical skills and expand your experience Travel healthcare lets you take your professional career to the next level while maintaining your flexibility and freedom.
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As we strive to halt degenerative diseases, we seek talented CMC leadership to lead tech transfer to our late-phase and commercial CDMO, manage DP production for our Phase III trials, prepare the CMC strategy for BLA submission, and build a manufacturing organization for commercialization.
$230,000 a yearFull-timeExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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The neuro-oncologist will have opportunities to expand and lead the neuro-oncology clinical trials program and to collaborate closely with laboratory-based investigators on translational research studies.
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Work effectively in cross-organization environment by collaborating with clinical investigators and industry partners to develop Pathology department support for projects requiring clinical research laboratory testing, including liquid biopsy testing and tissue-based biomarker assays.
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Understanding of industry standard technologies to support Clinical Development needs (e.g., CTMS, IRT, eCOA, SAS, R or Python, Data Warehouses, SharePoint) Experience integrating the EDC database with other clinical trial modules (e.g.: lab, safety, IRT, coding etc.
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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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S degree required with a clinical focus in perinatology/neonatology or attendance and completion of a NNP program. The Neonatal Nurse Practitioner (NNP) functions in collaboration with the neonatologists to provide direct patient care to the neonatal population and functions as an integral part of the Perinatal Team. Master.
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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. Expertise in Veeva Vault or similar clinical trial management systems (CTMS), electronic trial master file (eTMF), or regulatory document management systems.
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Defines strategy for and oversees tactical execution strategic plan by direct reports to provide effective oversight of research, assay development in support of pre-clinical and clinical research, GLP animal studies, in vitro diagnostic development, and all R&D vendors.
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This is a remote/home-based position, offering flexibility and autonomy to manage territory activities effectively while working closely with cross-functional teams.
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Will be required to demonstrate comprehensive knowledge in Avionics/ElectronicsSpecial Position RequirementsSchedule: 3rd shift: 9pm – 7:30am, 4-day work week. Line Maintenance TechnicianEast Boston, MA (Onsite)Position SummaryThales is looking for a Line Maintenance Technician performs line maintenance work, installation work, repair station work, and ground equipment maintenance work on the Thales In-Flight Entertainment (IFE) Systems in accordance with Federal Aviation Administration Regulations (FARs), airline customers’ maintenance manuals and internal operating procedures.
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clinical trials shift work jobs Company: Emory University in Boston, MA
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