- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to applicable Daiichi Sankyo and regulatory requirements. Functional Expertise:Reviews/approves clinical study related documents (eg, Protocols, Data Management ... Plan, Clinical Study Reports).Leads and drives the data review process in collaboration with the study team to ensure data qualityParticipates in audits and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities ... external sources.Ensure prompt and thorough review of requests for de-identified company clinical trial data .Ensure company clinical trial data on the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs ... EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical... Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Performs literature review and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is ... trial processes and functions including experience in one or more clinical trial operations functions / sub-functions ( Data Management, Biostatistics, … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all ... and Medical Access/Expanded Access (MAP)/(EAP)activities in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and… more
- Insmed Incorporated (San Diego, CA)
- …effective scientific and administrative operations. Operates, maintains, and repairs clinical laboratory equipment within scope of training including routine ... QC database. Set up and validate new assays as assigned by the manager .ResponsibilitiesManage and direct work responsibilities for team as well as prioritize tasks… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously. ResponsibilitiesPerform all programming ... areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data ... data review listings and reports to support Data Management and clinical teams.Develop, implement and… more
- Merck & Co. (North Wales, PA)
- … trial team.Leading medical monitoring team in review and interpretation of clinical data /medical protocol deviations in collaborations with the Clinical ... in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.SummaryThis Data Governance Communications Manager will be a critical part of the ... Center for Data Governance (CFDG) execution of the change management efforts...in life sciences, pharma or informatics industry working with clinical trials, genomics / biomarkers, discovery, commercial, real world… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for ... management.- Develop and implement strategies for cleansing and standardizing data , with a focus on eg, clinical , product, and vendor data and Identify and… more
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