- Eisai, Inc (Nutley, NJ)
- …research is required.#LI-MI1#IND123#LI-RemoteEisai Salary Transparency Language:The base salary range for the Associate Director, Clinical Data Science - CEG ... difference. If this is your profile, we want to hear from you. The Clinical Data Science team at Eisai, Inc., is expanding its capabilities by acquiring in-house… more
- Merck & Co. (Rahway, NJ)
- …existing and pipeline products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director, ... for growth opportunitiesThe Vocabulary Specialist may lead or participate in:Internal clinical data standards forumsStandards development teams and data… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Novo Nordisk Inc. (Atlanta, GA)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... relevant regulatory requirements Ensure accuracy, validity and completeness of data collected at clinical trial sites in...validity and completeness of data collected at clinical trial sites in accordance with the protocol, Monitoring… 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 ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… 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 ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Merck & Co. (North Wales, PA)
- …and statistical analysis methods fundamental to effective pharmaceutical R&D.- The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment, ... Lead and provide statistical support for related drug/vaccine projects in Clinical Safety StatisticsInteract with Safety Physicians, Safety Scientists, Clinical … more
- Merck & Co. (North Wales, PA)
- …systems data (eg our company's IT data hub - InForm, DMW, Clinical Data Repository (CDR), Site Management Authoring and Reporting Tool (SMART) and others ... business critical that our company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. REAIM...and preserved.- Under the oversight of the System and Data Integration Lead (SDIL), the Associate SDIL… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …SDTM and industry standard data collection practices preferred- 7+ years Clinical data management experience in a medical device, pharmaceutical company, or ... equal opportunity employer including veterans and people with disabilities. Summary The Associate Director, External Data Management, is accountable for the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary Position manages the end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other ... development processes and global submissions. This position provides leadership within Data Management by partnering with internal and external stakeholders to… more
- Tris Pharma (Monmouth Junction, NJ)
- …FUNCTIONS Actively participates in, or leads various aspects of preclinical or clinical data review including, but not limited to: adverse events, ... data management and safety management plans Ensures clinical data collection proceeds in a manner...licenses or certificates preferred:Advanced degree (MS, MPH, PhD, PharmD, etc.) Clinical Research Associate (CRA) or Clinical… more
- Merck & Co. (North Wales, PA)
- …least 2 years of experience in publication managementUnderstanding of the clinical development process andclinical study data for assigned ... Job DescriptionOverview:The Associate Director Publication (Pub) Manager is the central...the selection of appropriate journals and congresses for scientific data dissemination. They work closely with both internal writing… more
- Merck & Co. (Rahway, NJ)
- …Quantitative Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical ... organization and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to registration.… more
- Merck & Co. (North Wales, PA)
- …systems and database expertise. Familiarity with statistical analysis methods and clinical data management concepts.US and/or worldwide drug or vaccine ... according to quality, compliance and timeliness requirements.-Expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director, Quantitative Systems Pharmacology (QSP) will work within the Quantitative ... Clinical Pharmacology (QCP) group to develop and apply QSP...virtual population workflow is desirableExperience with general programming and data analysis tools/languages such as Python or R would… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …training and ensure effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis- Develop and maintain necessary programming macros ... review of Study Date Tabulation Model (SDTM) and analysis (including Analysis Data Model (ADaM)) datasets as well as TLFs generated by statistical vendor,… 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 ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...This includes leading processes and technology improvements to link Clinical trial site needs, Finance and Supply forecasts that… more
- Catalent (San Diego, CA)
- Job Title: Quality Assurance Associate , Analytical City: San Diego State : CA JOB DESCRIPTION:Review of analytical release and stability data , involving review ... new compounds to the site involving review of toxicology data and performing a nitrosamine assessment to ensure the...or support client audits along with the Director and Associate Director of Quality AssuranceManage a direct report and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionBiologics Process R&D Associate ScientistOur Research Scientists are our Inventors.- Using innovative thinking, state-of-the-art facilities, and ... To achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing while providing… more
- Merck & Co. (North Wales, PA)
- …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
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