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The Clinical Trial Associate, SSU will aid in study start up activities for Fractyl's global clinical program, draft SSU documents, site regulatory document review and approval, and IRB/EC and regulatory submissions and approvals.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Responsible for scientific leadership and execution of clinical studies, ensuring high-quality trial execution, data review, safety assessment, and interpretation of results. Serves as a technical resource for clinical issues, oversees data generation and validation, and conducts data review and analysis.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Ensure that CDM documentation is filed into the Trial Master File (TMF) according to SOPs and the study plans; review CDM files for completeness and accuracy. Ensure the activities described in the Data Management Plan (DMP) are executed in accordance with the DMP, including data acquisition, data transfer, data reconciliation and review, medical coding, data extract and rolling data freeze, data lock and database lock.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Design and develop data capturing tools: Electronic Data Capture (EDC) Systems (Eg: iMedidata Rave and IBM Clinical) eCOA, IRT; Manage electronic Trial Master File (eTMF) QC review eg: Veeva Vault; Lead the Audit and Inspection/Submission Readiness activities like documentation of QC and preparing Storyboards (Eg: FDA/EMA Submissions.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Review, update, or write company SOPs in partnership with the pharmacovigilance and clinical team related to Pharmacovigilance and clinical trials to ensure their compliance with EMA, ICH, and FDA guidelines.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Review clinical documentation to determine appropriateness of fit for evaluation at Cortica Conduct developmental interviews with caregivers, may include utilizing interpreter services Perform Autism- specific, diagnostic assessments (e.g., ADOS-2, tele-ASD-peds, CARS-2), SCQ, Vineland, and potentially other assessments as clinically indicated.
Part-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Provide QA review of various procedures, clinical protocols, investigators brochure, clinical study reports and pharmacovigilance system management files and other relevant documents as needed.
Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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The Research Data Analyst will manage large sets of genomic, physiological, neuroimaging, clinical, and behavioral data derived from a wide variety of translational studies. At both sites, in conjunction with the Principal Investigator, the analyst will help develop and implement new research protocols including design, data collection systems, and institutional review board approval and amendments.
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Assist in contract and budget negotiations with clinical sites and vendors as well as budget review and forecasting. Independently manage interactions with clinical monitors, data management, safety, regulatory, pharmaceutical science and QA team members, both internally and externally.
Full-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Familiarity with clinical data review and data management processes. Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review, and report writing.
$125,000 - $175,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Collaborate with internal/external experts in Clinical Development, Biostatistics, Clinical Pharmacology, Translational Medicine, Clinical Operations and Data Management to support clinical trial execution.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Perform ongoing and timely clinical trial data review in the form of listings, tables, patient profiles and live clinical database. Collaborate and liaise with clinical sites to support overall clinical trial participant management, data review activities and facilitating issue resolution.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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In conjunction with the Principal Investigator, develops and implements new research protocols including design, data collection systems and institutional review board approval. Coordinates the implementation, both internally and externally, of sponsored clinical research studies.
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May simultaneously function as lead CDM for multiple clinical trials or oversee the data management across a program. We are seeking a Senior Manager to lead Clinical Data Management (CDM) activities for clinical studies or clinical program(s.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP) Provide guidance on clinical data management to CDM staff, study teams, vendors, and management.
ExpandApply NowActive JobUpdated 3 days ago
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