- 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
- Novo Nordisk Inc. (Irvine, CA)
- …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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key… more
- DivIHN Integration Inc (Atlanta, GA)
- …SOPs, supervising and performing database development, testing, validation, reviewing and processing clinical trial data to ensure the completeness, accuracy and ... consistency of clinical trials databases. Looking for a person...system exp- not mandatory. Essential Duties AND Responsibilities: Designs clinical trial specific subject Case Report Forms… more
- Eisai, Inc (NJ)
- …the development of service provider strategy and outsourcing requirements for Phase I-IV clinical trials (65%): Manages the entire clinical outsourcing ... Suite#LI-TS1Eisai Salary Transparency Language:The base salary range for the Manager , Clinical Outsourcing is from :102,100-134,000Under current guidelines,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical trial outsourcing, health sciences or related field ( clinical trials ) required.Advanced WORD and Excel skills preferred.Excellent time management ... the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional...skills preferred.Experience with PH.1 - PH. IV clinical trial vendor contracts required.Experience with CRO… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oversight of the end-to-end lifecycle of biosamples (PK/ADA , CDx and biomarker) in clinical trials from study start-up to close-out including but not limited to ... knowledge of CLIA/CAP regulations and GLP guidelines preferredBasic knowledge of clinical trial design; understanding of the overall drug development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to uphold the ethical conduct of interventional, non-interventional, investigator-initiated trials , Managed Access programs and Collaborative Research to the highest ... to uphold the ethical conduct of interventional, non-interventional, investigator-initiated trials , Managed Access programs and Collaborative Research to the highest… more
- Eisai, Inc (Nutley, NJ)
- …includes overseeing the daily global eTMF system related activities relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness ... profile, we want to hear from you. The Sr. Manager is to lead collaboration efforts with R&D IT...validation or user acceptance testing, and integrations with other clinical applications through change management. Maintains the eTMF system… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- … regarding the study implementation process.Study Initiation: Plan, organize, implement clinical trials /research studies to effectively meet goals and ensure ... are submitted to sponsor in a timely manner, eg, 1572, Confidentiality Agreement, clinical trial agreements, IRB approval letter, Financial Disclosures, etc., as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oncology, with a deep understanding of the drug discovery and development process, clinical trials , and regulatory requirements. TravelAbility to travel up to 5% ... areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provides US market access input to Global and US stakeholders to inform clinical trial programs, guide evidence generation development, payer value stories, and ... of cell therapy reimbursement. Shape the payer value story, supported by credible clinical , health economics and quality of life messages as the market and the… more
- Axelon Services Corporation (Princeton, NJ)
- …strategies within a specific therapeutic area(s) and is accountable to support clinical trial vendor partnerships across select or multiple service categories ... of clinical trial activities in R&D. Key Responsibilities: - Drive outsourcing activities by interfacing with operational teams, support groups and service… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …scenarios and strategy for all pipeline products starting in Phase II clinical trials . Generates insights to support G3 decision-making Assesses investments ... in payer contracts and develops patient copay program strategy in collaboration with marketing colleagues. Provides strategic guidance on how to balance these investments across the franchise Supports contracting strategy and roadmap development for the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal relationships may include MA management, MA project management, Medical Communications, Clinical Trial Management, Clinical Development and Outcomes ... interests on cross-functional teams including, Field Medical Affairs, Medical Operations, Clinical Trial Management, HEOR, Market Access, Marketing and other… more
- DivIHN Integration Inc (Atlanta, GA)
- …manner. Strong organizational skills and meticulous attention to detail. Familiarity with clinical trial -related and regulatory clinical submission templates ... writing skills. 5 years of on-the-job experience in scientific/medical writing (eg, clinical trial and regulatory documents) preferred but not mandatory. About… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …as required. Essential Tasks and ResponsibilitiesMaintains management of data throughout a clinical trial . Enters study participant information (data) into all ... About the Role:Job SummaryUnder the direction of the research manager , the research data coordinator is responsible for completing...required software applications (ie EMR, Clinical Trials Management System, sponsor specific database,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …NOTE: This Project Lead Role is an Individual Contributor and sits at the Manager Grade level. This position is responsible for enabling the on-time delivery of ... clinical supplies across the DSI portfolio. This role as...to CSO Supply Planning as requested.Responsible for updating relevant Trial Master Files (TMF) with CSO-related documentsSupports the CSO… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …process in line with the approved protocol, including grant sponsored and clinical trial projectsManage and communicate effectively with Research Leadership ... / securely stored in a timely manner, eg, 1572, Confidentiality Agreement, clinical trial agreements, IRB approval letter, Financial Disclosures, etc., as… more
