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Experience in all aspects of protocol conduct, both early and late phases, including protocol writing, start-up, study execution, analysis, and reporting Sufficient content expertise to be able to meaningfully contribute to document development and data review and interpretation under the direction and oversight of the CMO. Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices, and clinical trials guidelines is required.
$250,000 - $315,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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10 years or more of experience in pharmaceutical clinical drug development in industry including protocol development; study initiation and follow-up; IRB/EC submissions and interactions; review of clinical study data listings; review and/or preparation of clinical study reports.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Ensure study team members and vendors are trained on protocol, relevant studydocuments, and key decisions at study start-up and throughout the duration of thestudy. Participation in large multi-center and/or global trials, investigational site andCRO management, data collection, and study protocol compliance.
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This individual will collaborate closely with the cross-functional teams on protocol development, study execution, be responsible for data analysis and interpretation of results, and work closely with Data Management and Statistical Programming resources to achieve all Biometric deliverables and activities at CROs. Additional analysis support of non-clinical / biomarker /CMC data and derive insight to contribute to Ascendis’ scientific research may be requested.
$190,000 - $215,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Support external investigators, MSs, GMA and MA stakeholder to develop and submit rigorous research proposals to GRCAssess and rate proposals submitted for GMA requests for proposals (RFPs)Act as reviewer for study protocols for functional (GMA) and cross-functional protocol review boards.
$191,335 - $247,610Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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These activities include, but are not limited to, study protocol preparation, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications and scientific presentations.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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This position will play a key role in driving the execution of studies from indication selection, protocol concept, design, and conduct, to final report including interpretation of clinical data, and preparation of documents for filing with regulatory agencies.
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Monitors study activities in region to ensure compliance with study protocol, SOPs, ICH/GCP and all other relevant regulations. Influences regional leaders to generate, manage, and maintain high quality study start up and recruitment timelines for region and tracks their progress to plan.
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Author the protocol statistical sections and generate statistical analysis plans and study randomization. Perform analysis, interpret study results, and collaborate with study team to produce safety monitoring reports, interim and final reports, and publications.
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Activities include but are not limited to protocol development, support study startup, oversight of trial execution, recruitment, ongoing clinical development management and closeout as appropriate.
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Participates in the functional review of study protocol and other study related documents such as clinical sample management plan, study communication plan, or presentations for Investigator and/or Study Kick-Off meeting.
Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Lead or support the development of study plans and system set-up and UAT; participate in the preparation and ensure operational excellence of protocol, CRF, CSR, and other key study deliverables.
$80 - $90 an hourExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Contribute to investigator meeting presentations, review study documentation, oversee safety data review, and provide medical support to Business Development. You will provide therapeutic and drug development expertise and interact with Sponsors and investigative sites on protocol medical issues.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Plan observational studies and draft protocol synopsis (or protocol concept sheet) Draft and review observational study analysis specifications, including statistical analysis plans (SAPs.
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