- Eisai, Inc (Nutley, NJ)
- …of the study from protocol concept to final report including interpretation of clinical data .Serves as Medical Monitor (where applicable) to review and monitor ... study data .Implements strategies to identify, monitor and resolve clinical program/trial issues.Interprets study data and develops integrated summaries of … more
- Genmab (NJ)
- …in a multi-study, multi-disciplinary atmosphere in a matrix environment Experience in clinical data management and/or trial management experience with technical ... consumers and externally consumers Serves as a liaison between Clinical Programming and External Data Management to ensure data standardization alignment and… more
- Insmed Incorporated (NJ)
- …programs including monitoring of clinical studies, review & interpretation of clinical trial data , authoring clinical study and regulatory communications ... for all issues identified which may affect the quality and integrity of clinical studies.Perform medical monitoring, coding, and data cleaning in collaboration… more
- Genmab (NJ)
- …Portfolio and Strategic LeadershipServe as a portfolio‑level lead for external data quality and clinical data ‑related operational strategy.Drive ... improvement initiatives that enhance efficiency, consistency, and inspection readiness across Clinical Operations and Clinical Data Management.Lead the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the safety leadership and serving as the primary point of contact.Review and analyze data from clinical trials, post-marketing and other relevant sources for the ... around rare diseases and immune disorders. Summary: The Senior Director, Clinical Safety, will lead the development and implementation of integrated project/product… more
- Merck & Co. (North Wales, PA)
- …Biopharmaceutics, Business Administration, Business Management, Business Technology, Change Management, Clinical Data Management, Clinical Study Management, ... technology, business operations. Required Experience: 12 years of experience in Clinical Trial Operations, Data Management or related biopharmaceutical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of National Advisory Board meetings, at the discretion of Executive Director) Deliver clinical data and other presentations at National Advisory Board meetings ... and gain feedback from advisors Support other advisory boards with clinical data and other medical presentations Partner with professional associations and their… more
- Eisai, Inc (Nutley, NJ)
- …imaging manuals, and transmittal forms-and contribute to the development and approval of clinical data transfer specifications, including CRF data supporting ... and issue resolution in collaboration with imaging core labs, clinical operations, and data management, and contribute to tumor assessment data … more
- Merck & Co. (North Wales, PA)
- …be programmed; an understanding of statistical terminology and concepts Familiarity with clinical data management concepts Experience in CDISC and ADaM standards ... Specific Required Skills and Experience: Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH;… more
- Merck & Co. (Rahway, NJ)
- …be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM ... Specific Required Skills and Experience: Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH;… more
- Merck & Co. (North Wales, PA)
- …be programmed; an understanding of statistical terminology and conceptsFamiliarity with clinical data management conceptsExperience in CDISC and ADaM ... Specific Required Skills and Experience: Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH;… more
- Merck & Co. (Rahway, NJ)
- …and programming requests in close collaboration with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data , transform the ... Specific Required Skills and Experience: Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO,… more
- Merck & Co. (Rahway, NJ)
- …Ambition - Respect - Inclusion.Design and organization of paper and Electronic Data Capture (EDC) clinical studies that meet scientific and regulatory ... primary function is to design, coordinate, monitor, and report clinical laboratory and field studies that will support the...and procedures - Plan and coordinate the monitoring and data management activities of each study.Ensure that the study… more
- Insmed Incorporated (NJ)
- …throughout the system lifecycle.Evaluate and manage third-party vendors and SaaS/cloud-based clinical systems for compliance with data integrity and ... you?About the Role:We're looking for a Sr Manager, IT Clinical Systems Validation in the IT team to help...landscape ensuring the highest standards of regulatory compliance and data integrity.What You'll Do: In this role, you'll have… more
- Merck & Co. (North Wales, PA)
- …for analysis and programming requests in close collaboration with statistical and clinical colleagues, retrieve the required data , and then transform the ... Specific Required Skills and Experience:Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO,… more
- Merck & Co. (North Wales, PA)
- …project level Position Specific Required Skills and Experience: Programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic ... in CDISC SDTM and ADaM standardsSignificant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPHDesigns… more
- Insmed Incorporated (NJ)
- …of products in development. You'll also:Be responsible for appropriate review of all safety data from various sources (eg pre- clinical , clinical trial ... from large volumes of scientific information.Experience presenting drug safety topics, clinical and safety data to regulatory authorities, health authorities,… more
- Legend Biotech USA, Inc. (Atlanta, GA)
- …Affairs team. Direct education for healthcare professionals treating oncology patients on clinical data , adverse event management, and mechanism of action for ... and tactics.Assist in the oversight of Legend Biotech sponsored clinical trial sites to include, but not limited to,...and members of the Legend Biotech Medical Affairs and Clinical Development teams; Addressing AE management and education as… more
- Merck & Co. (Rahway, NJ)
- …Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers.Develop supplementary clinical data package for submission to Health Technology Assessment ... access in collaboration with internal teams, and provide input into clinical , payer/access, marketing and value evidence generation strategies and programs.In… more
- University Health (San Antonio, TX)
- …a sound knowledge of clinical laboratory science. Requires evaluating clinical data and quality control information. Responsible for overseeing employees ... role. Performs duties within the Clinical Laboratories area, which requires...college or university and successful completion of a structured clinical program (CAHEA approved) and certified in clinical… more
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