- Merck & Co. (Rahway, NJ)
- …portfolio. The Global Clinical Operations (GDO) department in housed in Clinical Data Management and Standards (GDMS) within the GCTO organization. GDO ... Data Management activities with the support and oversight of a Senior Clinical Data Manager (SCDM)/Lead Clinical Data Manager (LCDM); issuing queries… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position The Novo Nordisk Real World Evidence (RWE) / Clinical Data Science & Evidence (CDSE) - Fellow is responsible for supporting ... works closely with all colleagues in both the RWE and broader Clinical Data Science & Evidence (CDSE) department. Essential Functions Lead observational research… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to applicable Daiichi Sankyo and regulatory requirements. Functional Expertise:Reviews/approves clinical study related documents (eg, Protocols, Data Management ... Plan, Clinical Study Reports).Leads and drives the data review process in collaboration with the study team to ensure data qualityParticipates in audits and… more
- Merck & Co. (North Wales, PA)
- …database set up)Lead medical monitoring team in review and interpretation of clinical data /medical protocol-deviations in collaboration with the Clinical ... position drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead, you will collaborate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and ensure the writing of high quality clinical trial protocols, review of clinical data and Clinical Study Reports (CSRs)/outputs throughout the project ... associated documents (writing of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus on patient safety and data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... plan by function and team; Interprets and react accordingly to new preclinical/ clinical data (eg; Go/No Go decisions, reprioritization, etc.); Operational Project… more
- Merck & Co. (Rahway, NJ)
- …on the planning, execution and close out of clinical trials within a program.- Clinical trials provide the required data which allows Merck to bring new ... materials - Prepare clinical narratives - Collaborate cross-functionally to monitor clinical study data to ensure quality, completeness, and integrity of… 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)
- …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)
- …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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …team of cross functional partners, including but not limited to: Global Clinical Operations, Global Regulatory Affairs, Biostatistics and Data Management, ... Indicators (KPIs) to analyze and report on diversity metrics in clinical trials- Monitor data and regularly communicate findings to senior leadership to make… 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)
- …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
- 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)
- …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
- Insmed Incorporated (San Diego, CA)
- …development of systems, practices, and procedures to ensure efficient and effective clinical trial execution including data management and analysis.Build and ... lists.OverviewThe primary responsibilities are to manage all aspects of clinical operations including study planning, financial oversight, project deadlines and… more
