- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and execution and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project, and ... rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all… more
- Novo Nordisk Inc. (WA)
- …the application of those principles to trial planning and conduct of clinical trials Demonstrates proficiency with computer skills (MS Office, MS Project, MS ... Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex… more
- Merck & Co. (Boston, MA)
- … clinical development strategies for investigational drugs and planning clinical trials (design, operational plans, settings) based on these ... development strategiesMonitoring and managing the conduct of ongoing or new clinical trials for investigational drugsAnalyzing and summarizing the clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution: As CSL for Phase 2 studies: Provides input on major milestones of trial , clinical trial plan and contingency planning, Analyzes, updates ... trials of medium to high complexity in design and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution: As CSL for Phase 2 studies: Provides input on major milestones of trial , clinical trial plan and contingency planning, Analyzes, updates ... trials of medium to high complexity in design and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory… more
- Tris Pharma (Monmouth Junction, NJ)
- …and maintain the GCP QA programs, policies, and SOPs.Ensure GCP compliance of clinical trials .Oversee and manage the qualification and auditing process and other ... and Partners during internal audits and Health Authority inspections.Conducts audits at Clinical trial sites and Contract Research Organizations to ensure the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... leader (CSL)Study Planning and Execution: Provides input on major milestones of trial , clinical trial plan and contingency planning; Analyzes and updates… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for investigator-sponsored studies (ISS) and ... and support of National Leaders/National Expert Panels for select clinical trials , in collaboration with Clinical...trials and with other MA tools (expertise in clinical trial methodology and conduct, GCP principles,… more
- Merck & Co. (North Wales, PA)
- …meeting. They will provide internal scientific leadership for cross-functional areas supporting clinical trials and will interact externally with key opinion ... developments, regulatory requirements, the competitive landscape, and commercial considerationsPlanning clinical trials (design, operational plans, settings) based… more
- Insmed Incorporated (San Diego, CA)
- …programs including monitoring of clinical studies, review & interpretation of clinical trial data, authoring clinical study and regulatory communications ... manuals in a cross-functional team.Supporting or preparing data interpretation and clinical trial reports.Preparing Investigator Alert letters and SAE reports… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external ... Provides medical input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site feasibility… more
- Merck & Co. (Rahway, NJ)
- … clinical development strategies for investigational or marketed Oncology drugsPlanning clinical trials (design, operational plans, settings) based on these ... development strategiesMonitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Oncology drugs.Analyzing and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …dedicated to the effective strategy, design, execution, and interpretation of Oncology clinical trials . Serves as a primary source of medical accountability ... and oversight for one or more clinical trials Matrix management responsibilities across the...input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …investigators is expected. The CS Group Lead will also ensure the writing of high-quality clinical trial protocols, review of clinical data and Clinical ... and people with disabilities. SummaryThis position will be the Clinical Science Group Lead in late phase development in...Group Lead in late phase development in the Global Clinical Science function. He/she will be responsible for managing… more
- Merck & Co. (North Wales, PA)
- … Clinical Safety StatisticsInteract with Safety Physicians, Safety Scientists, Clinical Trial Physicians , Regulatory, Early/Late Development Statistics, ... project management skills. --Good understanding of worldwide regulatory requirements and clinical trial expertise .Strong oral and written communication skills.… more
- Merck & Co. (Rahway, NJ)
- … clinical development strategies for investigational or marketed Oncology drugs;Planning clinical trials (design, operational plans, settings) based on these ... development strategies;Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Oncology drugs;Analyzing and… more
- Merck & Co. (Rahway, NJ)
- …Management, and other Company Research Laboratories Scientists in designing and analyzing clinical trials , and in coordinating the statistical activities for ... other potential problems arising in the design, conduct, and analysis of clinical trials , proposes solutions and carries them out.Develops individual protocols… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Manager Grade level. This position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role as CSO ( Clinical ... streams with key service providers and working with internal departments to progress clinical supply projects. Every effort has been made to identify the essential… more
- Merck & Co. (North Wales, PA)
- …software eg SAS and/or R.Thorough understanding of worldwide regulatory requirements and broad clinical trial expertise from phase I to V.-Strong oral and ... and statistical analysis methods fundamental to effective pharmaceutical R&D. The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment,… more
- Merck & Co. (North Wales, PA)
- …and other of our company's Research Laboratories Scientists in designing and analyzing clinical trials , and in coordinating the statistical activities for ... :Serves as statistical representative in the cross-functional teams for the clinical trial planning, execution, and reporting.Develops individual protocols and… more
