- Merck & Co. (North Wales, PA)
- …standard collection and mapping data definitions aligned with industry Clinical Data Interchange Standards Consortium (CDISC) standards and Health Authority ... the definition of maintenance of additional standards library componentsParticipate in standards data governance reviewsThe Global Clinical Data Standards… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including veterans and people with disabilities. Summary The Associate Director, Clinical Data Standards, is responsible for the development, maintenance, ... - Leadership, Direction, and Strategy:Leads implementation of Therapeutic level clinical data collection requirements including cross-functional standards… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medical device, pharmaceutical company, or similar environment (eg, CRO) requiredExperience with clinical data standards requiredDaiichi Sankyo, Inc. is an equal ... according to applicable Daiichi Sankyo and regulatory requirements.Functional Expertise:Reviews/approves clinical study related documents (eg, Protocols, Data … 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)
- …from external sources.Ensure prompt and thorough review of requests for de-identified company clinical trial data .Ensure company clinical trial data ... of key global laws, regulations and guidelines relating to clinical trial documents and data disclosure is...guidelines relating to clinical trial documents and data disclosure is desirable. preferredGood general knowledge of key… more
- Tris Pharma (Monmouth Junction, NJ)
- … Research Organization (CRO) and/or Medical Writer to contribute to drafting of clinical study reports and other reporting data documents; Participates in ... full clinical trial life cycle; Reviews, synthesizes and analyses clinical trial data and translates data into actionable plans at product… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and associated documents (writing of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus on patient safety and ... the writing of high-quality clinical trial protocols, review of clinical data and Clinical Study Reports (CSRs)/outputs throughout the project life… 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 ... program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective;… 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
- 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 ... complex data review listings and reports to support Data Management and clinical teams.Develop, implement and maintain SAS programming standards and performs… more
- Aequor (South San Francisco, CA)
- …develop machine learning modeling and prediction pipelines using multi-modal biomarker data from clinical trials. Responsibilities Maintain and develop in-house ... for application of open-source R and python Client modeling libraries to clinical trial data and real world data (from external partners, publicly available… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … data standards is required.Knowledge of CDISC and SDTM and industry standard data collection practices. Clinical data management experience in a medical ... Management, is accountable for an end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical... data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …applications and best practices as well as strong technical skills in working with ( clinical ) data . The position holder will require strong skills in continuous ... understanding and translation of business needs to AI/ML tasks, over data understanding and preparation, to modeling, validation and dissemination- Identify… more
- Eisai, Inc (Nutley, NJ)
- …responsibilities.Ensures the timely and appropriate collection, organization, and analysis of diverse data sources (eg, clinical trial data , patient ... understanding of statistical methodologies and their application in the context of non- clinical studies and related projects in AD and other therapeutic areas as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …global head of regulated bioanalysis will also form strategic internal (DMPRL, Clinical Operations, Data Management, Scientific Operations etc) and external ... position has extensive knowledge of regulated BA, DMPK, biological sciences, clinical pharmacology, BA strategic planning, regulatory guidance, and in-licensing and… more
- Merck & Co. (North Wales, PA)
- …heavily relies on accurate data collected from patients who are part of Clinical Trials. Trial Standards, Trial Design, Trial Data Collections, Trial Data ... from trial participants, in the right way to enable the Clinical Research to analyze data for efficacy, dosing, safety profiling and adverse events. The … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …business information, Supply Chain, Finance and HR preferred- 1 or More Years Experience with Clinical Trials Data , Genomics and Bio Marker Data , Real World ... research areas centered around rare diseases and immune disorders. Job Summary: Data Engineer will partner with business stakeholders and decision makers to develop… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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.Summary The Director, Clinical Safety, will be a product safety lead or part of a product… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(v) encouraging innovation.Build strong relationships with clinical development, clinical sciences, regulatory, biostats, data management, and other key ... around rare diseases and immune disorders.Summary The Executive Director, Global Clinical Operations Study Management Group Head has leadership and overall strategic… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …standards, and coding library management.Manages, reviews and approves medical coding of clinical data ensuring high quality; creates and manages the ... immune disorders. Summary Position manages the end-to-end delivery of medical coding data for assigned projects/studies collaborating with clinical and medical… more
