- Daiichi Sankyo, Inc. (Bernards, NJ)
- …on readiness for database lock; collects all appropriate signatures on the Clinical Database Lock Authorization Form.- Notifies study team that database ... ongoing basis to ensure data quality and data integrity of clinical trial database and externally generated electronic data files.- Reviews and manages updates… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …authoring, and management of Dose Preparation Instructions in support of clinical studies being conducted globally by Daiichi Sankyo. The candidate will ... collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical Development to collate the necessary… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and cultures.. Additionally, this position possesses advanced knowledge of clinical operations and relevant regulatory requirements. This position has advanced ... and risk managementResponsibilities: Leadership, Direction, and Strategy:In collaboration with Clinical Development and Clinical Operations as well as… more
- Genmab (NJ)
- …us!The Role:The Senior Statistical Manager acts as a biostatistician supporting the clinical development of compounds as compound lead, primarily up until proof of ... the vendorSupports compound responsible programmer in developing an integrated database specificationCDT member:Responsible for giving statistical input to overall… more
- Merck & Co. (North Wales, PA)
- …programming activities for multiple and/or late stage drug/vaccine clinical development projects. -Accountability predominantly includes the development and ... tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The… more
- Genmab (NJ)
- …us!The RoleThe Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early ... responsibilities as described below. The Associate Director contributes to clinical development strategies and plans.Responsibilities:Compound/Indication LevelAct as lead and… more
- Genmab (NJ)
- …Manager will support the Data Management, Statistics, Drug Safety, Medical, Clinical Pharmacology and Biomarker functions with the above by developing and ... consistencySupports the establishment and maintenance of Genmab SDTM and ADaM database standards.Performs database standards consistency checks on databases… more
- Merck & Co. (North Wales, PA)
- …: This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more ... tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.… more
- Merck & Co. (San Diego, CA)
- …in developing and deploying robust bioinformatics pipelines.Familiarity with database management and data warehousing concepts, particularly for integrating ... diverse biological and clinical datasets.Familiarity with drug-target interaction databases and resources relevant to pharmaceutical research.Experience with … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …work with Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations, Clinical Development, RA CMC) to keep processes, ... analyses for any issues identified, to define CAPAs/deviationsMaintain a GRA database for tracking process deviations / CAPAsCoordinate activities required to… more
- Merck & Co. (Rahway, NJ)
- …that accelerate the decision-making process from hit identification to clinical candidate delivery across different therapeutic areas and modalities at ... drug design, high-throughput experimentation.Experience with IT infrastructure such as database systems, cloud computing (such as Databricks, AWS), and… more
- Daiichi Sankyo, Inc. (Winston-Salem, NC)
- …hospitals, and community practices).Demonstrate understanding of current or pending clinical pathways in assigned accounts, and how they influence patient ... a current key customer target list, submits regular updates to the customer database and plans calls to meet goals.Reviews territorial reports with District Manager… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... in support of research and marketed products Create and maintain product/project database to record history of questions asked / responses received during FDA… more
- Daiichi Sankyo, Inc. (New York, NY)
- …hospitals, and community practices).Demonstrate understanding of current or pending clinical pathways in assigned accounts, and how they influence patient ... a current key customer target list, submits regular updates to the customer database and plans calls to meet goals.Reviews territorial reports with District Manager… more
- Corewell Health (Southfield, MI)
- …requirements for meetings or events. We are seeking a highly skilled and detail-oriented RN Clinical Database Specialist to join our team with a primary focus on ... William Beaumont University Hospital . The primary responsibilities include clinical data abstraction, data analysis, and supporting quality improvement initiatives… more
- Chenega Corporation (Cincinnati, OH)
- …**Research Database Developer** will provide comprehensive research and clinical database services, ensuring effective development, management, maintenance ... clinical data. + Provide training and support to clinical and research staff on database usage, data management, and data integration practices and systems… more
- Nuvance Health (Danbury, CT)
- …six years job-related experience. Excellent verbal and written communication skills. Clinical Research, Database /Data Registry Management, or Medical Records ... this role will be able to:* * Conduct in-depth chart review utilizing clinical knowledge and expertise using applicable criteria and definitions established by the… more
- Sanofi Group (Morristown, NJ)
- …and quality for clinical studies in order to deliver a comprehensive clinical database , and contributes to the optimization of data management processes and ... each clinical study in order to deliver a cleaned and accurate clinical database , allowing its statistical analysis and submission. + Acts as Clinical … more
- System One (Oro Valley, AZ)
- …of study-specific DMP. + Prepares and enters test data for user testing of clinical database and edit checks. + Participates in study-specific data entry ... incomplete, erroneous, and/or discrepant data. + Generates discrepancies and updates clinical database based on queries, data clarification forms, discrepancy… more
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