- Houston Methodist Academic Institute (Houston, TX)
- At Houston Methodist, the Manager Clinical Trials position is responsible for managing complex research projects that may involve single or multiple sites ... and coordination of clinical research projects. The Manager Clinical Trials position monitors...provides guidance to department and HMRI leadership on relevant clinical trial issues and development.The manager… more
- 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. (Plainsboro, NJ)
- … development experience in the pharmaceutical industry Minimum 2 years of experience as a Clinical Trial /Project Manager Experience with global clinical ... The CPM will be responsible for all aspects of clinical trial management aimed at treating a...You will be responsible for the successful execution of clinical trials from protocol finalization through closeout.… 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
- Merck & Co. (North Wales, PA)
- …Summary: This position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have ... execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on a clinical trial team.Leading medical monitoring… more
- Aequor (Fort Worth, TX)
- …CTMS, Contract Management System, and Grants Manager . Detailed understanding of the clinical trial process and robust understanding of the management of ... Administration or related or the experience. o Experience in Clinical Trials and/or Study Budget development. Detailed... and/or Study Budget development. Detailed understanding of the clinical trial process and robust understanding of… 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
- 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
- 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
- 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
- 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
- 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
- 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)
- …may include Medical Affairs, Regulatory Affairs, Marketing, Learning & Development, Clinical Trial Management, and Clinical Development. Essential ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and will also have a reporting relationship with a manager /preceptor in the respective functional areas during their rotations.… more
- Chenega Corporation (Washington, DC)
- …& Solutions, LLC, a Chenega Professional Services' company, is looking for an Clinical Trials Biostatistician to support the Advanced Research Projects Agency ... solutions for our clients. Responsibilities Serve as lead for biomedical and clinical trial design, management, and results analysis.Utilize your biostatistical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …inspection/release of materials related to manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP ... handling tasks in a backup role, as needed. Updates supervisor/ manager of work status or problems with recommendations for...of 2 years of experience with quality support in clinical manufacture or NPI is preferred.Experience in clinical… more
