- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Data Standards Vocabulary Specialist, Associate Director, is a subject matter expert in CDISC Controlled Terminology and ... for growth opportunitiesThe Vocabulary Specialist may lead or participate in:Internal clinical data standards forumsStandards development teams and data… more
- Merck & Co. (Rahway, NJ)
- …the development and maintenance of comprehensive databases designed to collect and retain clinical data pertinent to laboratory challenges and clinical field ... clinical databases and ensuring the integrity, consistency, and confidentiality of data collected during laboratory challenges and clinical field trials. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager, Clinical Data Repository Administration is a member of the Biostatistics and ... review and acceptance of the study user and role assignments in the Clinical Data Repository. Functional Expertise: Serve as a subject matter expert and provide… more
- Genmab (NJ)
- …Director, Data Management is operationally responsible for the oversight of Clinical Data Management activities related to the effective planning, and timely ... excellence.Responsibilities:Contributes to and implements the strategic direction of the Clinical Data Management functional areaContributes to the overall… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review Plan ... Organization (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and help teams prepare for governance interactions. Independently manage interactions with clinical leads, data management, safety, regulatory, and QA team ... NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating...study progress and surveillance of key efficacy and safety data points. Collaborate with other functions (at CRO or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …site selection meet study requirements Participate in the development and testing of clinical systems (eg, data capture, IxRS) Ensure internal and external ... well as budget review and forecasting Independently manage interactions with clinical monitors, data management, safety, regulatory, pharmaceutical science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with internal and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data visualizations, external ... to achieve business objectives. It requires extensive knowledge of clinical data programming, external data handling, techniques, standards, methodologies,… more
- Aequor (South San Francisco, CA)
- … data visualization and conduct predictive analysis to increase the efficiency of clinical data review and clinical operations with the ultimate goal ... CA Duration : 1 year The Position: The mission of the Data Intelligence team in the Early Clinical Development (ECD) department is to optimize the support of … more
- Insmed Incorporated (San Diego, CA)
- …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.Medical monitoring, coding, and data cleaning in collaboration with … more
- Merck & Co. (Rahway, NJ)
- …molecules, biologics, and vaccinesBroad understanding of drug discovery, development and research, clinical data coding and experience working within a regulated ... Job DescriptionThe Associate Director of Scientific Nomenclature and Reference Data is responsible for assigning accurate chemical nomenclature to small molecules… 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 ... as other research areas centered around rare diseases and immune disorders.SummaryThe Director, Clinical Safety, will be a product safety lead or part of a product… more
- Merck & Co. (Rahway, NJ)
- …exposure to clinical drug development with emphasis on key elements of clinical trial planning, execution, data analysis and reporting of clinical ... participate in the writing of research protocols, conduct of clinical trials, safety monitoring, analysis of data ...of clinical trials, safety monitoring, analysis of data and communication of study findings. (b) Global Regulatory… more
- Aequor (South San Francisco, CA)
- …with expertise in clinical bioinformatics, statistical analysis, predictive modeling, clinical data handling, biomarker & assay developments. This is an ... executing biomarker data analysis plans associated with various stages of clinical trials 2. Conduct rigorous and impactful statistical analyses on clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …participating in regulatory agency inspections, partner audits, and QA inspections preferred- Clinical Data Repository system. Required Travel Ability to travel ... up to 10% Travel to DSE, DSJ and other DS locations which will include overnight travel. Ability to travel to the US, EU and Japan.Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …policies and procedures. Relationships This position reports to a Senior Director within the Clinical Data Science & Evidence (CDSE) - RWE team. This role will ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Merck & Co. (North Wales, PA)
- …describe methodology to be programmed; applying statistical terminology and concepts; working with clinical data management concepts; working with Clinical ... clinical studies using deep scientific knowledge, statistical analysis and high-quality data to support decision making in clinical trials.Support statistical… more
