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Ensure DM project deliverables are completed on time and in accordance with quality standards and regulatory requirements from study start-up through study closure/archival. Strong knowledge and experience in EDC and other key technologies (e.g., IXRS, data visualization.
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With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.
Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Experience working with Veeva Vault, Medidata Rave EDC, SAS and similar systems a plus. This includes all global validated applications across the Clinical Development, Clinical Operations, Biostats, Regulatory, Drug Safety, and Pharmacovigilance business units.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Assist in the gathering of EDC design requirements from stakeholders and to address the needs of sites (e.g., investigator, study coordinator, study monitor). The Associate Director, Clinical Data Management will manage all data management (DM) activities from start-up through long term follow up and archival, overseeing high quality databases for analysis and potential regulatory submissions.
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Clinical trial, oncology, patient recruitment, Study Oversight, Chart review, Pre-screening patients, Adverse event reporting, Oncology nursing, clinical research, regulatory, gcp, irb, edc, epic, clinical studies, recruitment.
$40 - $48 an hourFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Participates in assigned activities related to user acceptance testing (UAT) of clinical systems, including EDC and interactive response technology (IRT) and may contribute to the authoring of systems requirements.
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Study Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL.
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This role is an opportunity for an experienced Clinical Operations Professional with technical expertise supporting Phase I-III clinical trials in an industry setting and a strong knowledge of clinical operations, Good Clinical Practice (GCP), and U.S. Food and Drug Administration (FDA) regulatory requirements.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Experience with clinical, regulatory, and data aspects of trials, including but not limited to field monitoring, data management, biostatistics, and medical writing. Proficient with the use of computers and Microsoft Office Suite of products, as well as experience with tools specific to clinical trial management (e.g., CTMS, EDC, IVRS, eTMF, financial management systems, etc.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Addresses electronic data capture (EDC) queries under guidance of the study coordinator. This person will promote Good Clinical Practices in the conduct of clinical investigations by possessing an in-depth knowledge of FDA regulations and human subject protection, thus, ensuring compliance with protocol and regulatory requirements.
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Familiarity with EDC, IRT, eTMF, CTMS, SAS, Argus, clinical analytics, safety, LMS, QMS, TraceLink, Veeva Vault and/or regulatory systems. Solid domain knowledge of business processes and related data types in functional areas (Pre-clinical, clinical development, clinical operations, regulatory, pharmacovigilance, biostatistics, data management, quality, and manufacturing), to support technology solutions.
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We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.
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Any EDC platform such as REDCap, Medidata, Rave) Responsibilities may include but are not limited to: submission of protocols & renewals to IRB & scientific review boards; management & submission of electronic data forms to Sponsors, CROs & regulatory agencies; screening for eligibility; monitoring and timely reporting of adverse events; toxicities and protocol deviations; scheduling subjects' visits; coordinating clinical, laboratory and data management activities; processing and submitting laboratory specimens.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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The incumbent is also responsible for maintaining communication with all elements of a multi-level research network, interacting with sponsoring agencies and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors.
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Work with internal colleagues, offshore resources, and external vendors to ensure efficient, high-quality production of curated data for downstream use in sample tracking, production of statistical outputs for clinical study reports, and statistical analysis reports in support of Gilead's regulatory, scientific, and business objectives.
$130,220 - $168,520Full-timeExpandApply NowActive JobUpdated 13 days ago
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