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As a company, we are honored to have our Technical and Professional Services groups ranked #1 in KLAS by our clients, including winning 2022’s Top Overall Implementation Services Firm and 2023's Best in KLAS for both Data Archiving and Clinical Optimization awards.
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The Clinical Project Manager / Sr. Clinical Project Manager (CPM) provides operational leadership of one or more clinical trials from protocol development through clinical study report, and ensure activities are executed in accordance with the protocol, ICH/GCP guidelines, applicable regulations, and company's policies and procedures and corporate goals.
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Providing advice on regulatory issues for both marketed and pipeline products; actively collaborates with management, Global Regulatory Lead and cross functional colleagues within (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.
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Act as the primary contact point for safety project-related matters on assigned clinical studies. This individual may serve as a liaison to external contract safety providers and company personnel for safety issues, working in close collaboration with colleagues from Clinical Operations, Regulatory Affairs, Quality and Medical Affairs.
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As an integral member of the team, the Senior Clinical Project Manager will report to the VP of Clinical Development Operations and work closely with cross functional team members, clinical research organizations (CROs), and other vendors to ensure clinical trial execution is conducted in accordance with the protocol, SOPs, ICH/GCP/regulatory guidelines, and company goals while ensuring quality of study execution and timely delivery of trial milestones.
Full-timeExpandApply NowActive JobUpdated 27 days ago - UpvoteDownvoteShare Job
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Reporting to the Senior Director, Head of Clinical Operations, the Senior Clinical Project Manager/Associate Director will contribute to the overall success of PepGen’s Clinical Development of its Enhanced Delivery Oligonucleotide (EDO) technology.
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Convene and provide manage project teams, which may consist of staff from the Office of Clinical Affairs and MassHealth with expertise in quality, data and analytics, and data management and/or staff from relevant vendors.
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Highlights from the late-stage portfolio include a pivotal clinical trial in Sudan for a new mycetoma therapy, and a Phase II clinical trial in the Peruvian Amazon for a new malaria medicine.
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Minimum of 3-5 years of experience in project management in a Healthcare IT or related setting working with leading industry Electronic Health Records (I.e., Epic®, Cerner, Meditech, NextGen) or ancillary clinical systems.
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Matrix with other parts of the Takeda organizationincludingchemistry, DMPK, safety, translational,and clinical development to advance pipeline programs. Contribute to multiple preclinical or clinical projects, actingas senior scientificconsultant and /orproject team leader.
$169,400 - $266,200 a yearFull-timeExpandApply NowActive JobUpdated 27 days ago - UpvoteDownvoteShare Job
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Founded by an internationally recognized team of neurodegenerative biologists from Harvard Medical School and Harvard University, QurAlis is a clinical-stage biotechnology company advancing a pipeline with therapeutic candidates that target specific components of ALS and FTD pathology and defined patient populations based on both disease-causing genetic mutation(s) and clinical biomarkers.
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As a result of your expertise and efforts we will optimize the use of our clinical trials samples to meet protocol requirements, deliver on our promise to our rare disease patients and advance our science by ensuring our scientists have timely access to all available samples to answer new research questions.
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Oversee the project’s clinical services and clinical documentation, ensuring timely and accurate recordkeeping of service delivery. Collaborate with the BCTC clinical and medical team to facilitate and ensure ongoing services and support.
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Experience: 7 years previous experience in a Project Manager rolein a clinical research setting with a progression of increased responsibility over time. Experienced managing oncology projects- working in either cell therapy or CAR-T. Required Skills: Strong knowledge of the drug development process and FDA regulations, ICH GCP guidelines, and their application to clinical trials.
Full-timeExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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The Director, Clinical Project Management works cross-functionally with the Epidemiology, Biostatistics, Clinical Informatics, Engineering, and Data Science teams to drive the scoping and execution of new projects.
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clinical job Title: project in Boston, MA
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