- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key internal and external ... stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries. Expert level written and verbal communication skills, strong… more
- Merck & Co. (Rahway, NJ)
- …and oversight of local operational clinical trial activities-in compliance with ICH/GCP and country regulations, company policies and procedures and-with ... to the timelines and key business metrics.Review and approve timesheets, GTT compliance , expense reports, time-off requests-and provide proper oversight of CTC's… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ... and link between Country Operations and clinical trial team (CTT).Responsible for project management of the assigned studies: pro-actively plans, drives and tracks… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …contacts and handles finalization of routine correspondence May act as GRT member Oversight of annual reports Participate in project team meetings as assigned ... projects/products/processes. Assist the Director/Associate Director in assuring Novo Nordisk compliance with internal SOPs and Federal and State regulations,… more
- Novo Nordisk Inc. (Boulder, CO)
- …Develops comprehensive, relevant resources (eg training program, FAQs) to enable compliance to change control process requirements across NN Boulder Develops and ... and executes regular surveillance, follow-up, and reporting program to ensure process compliance Deviations: Acts in role of primary process SME for the Deviation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …this position has moderate skills in continuous improvement, project management, change management, and risk management. ResponsibilitiesLeadership, Direction, ... and Strategy:Establishes Data Management strategy at the project and/or study level for a smaller number of...(eg, study startup, study conduct, study closeout, and reporting).Provides oversight for Data Management CRO and other third party… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project , and quality plans, and relevant ICH/GCP Guidelines Review protocols ... Sponsored Studies (CSS) and Medical Access/Expanded Access Program (MAP)/(EAP)Support the oversight of the overall global oncology review process of PhIV company… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).ResponsibilitiesReconcile the ... planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for Brand team/s, including all budget-related tracking, project management oversight , legal material review and process compliance , and other issues. ... diseases and immune disorders. Summary The primary responsibilities of the Manager , Omnichannel Marketing is to support the development, planning and implementation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …development, business analyses or consulting experience. required andPrior work experience as a project manager , project lead, or similar role within ... oversight of shared e-workspace. (eg, Teams sites, SharePoint).Additional non- Project related activities: The Associate Director, GOCD ensures positive /… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …management process for validated systems where necessary.Maintain effective communication with project stakeholders.- Provide oversight to assure that all ... validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider Outsourcing).… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Department At Novo Nordisk, we're committed to building the best Ethics, Compliance & Privacy (ECP) team in the pharmaceutical industry. Operating at the highest ... on new procedures, to auditing against local and corporate policies, to reporting compliance -related issues, ECP keeps us accountable every step of the way as we… more
- Novo Nordisk Inc. (Durham, NC)
- …duties & QA presence & process confirmation on shop floor. Relationships Manager , Quality Assurance. Essential Functions Ensures site compliance with ... on shop floor. Handles release of raw materials & provides quality oversight , review & approval of validation activities associated with minor changes to… more
- Insmed Incorporated (Bridgewater, NJ)
- …ethic and a positive, can-do attitude.Must be an experienced pharmaceutical/biotechnology program/ project manager with experience in leading drugs through all ... Management will utilize best-in-class program management support to provide end-to-end oversight of the program strategy and management for initiating, planning,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and support the PRA strategies and tactics of additional indications. With manager oversight , the individual will lead global pricing strategy development, ... strategies and pricing policies; in collaboration with key regions/markets Ensure compliance with legal requirements- Collaborate and provides input to Clinical on… more
- Dana-Farber Cancer Institute (Boston, MA)
- …with a goal to expand to 10+ affiliate centers. The CTO PI-Initiated Research Project Manager for WM-NET (CTO RPM) is responsible for assigned day-to-day ... management of several Phase I, II, III PI-Initiated / Multi-Center oncology trials.Assist senior manager (s) in the development of a project plan that serves as a… more
- EY (Mclean, VA)
- …initiatives, processes and issues around IT controls, cybersecurity, cloud, contractual compliance , and system management. You will assist in the testing of ... levels, and deepen sector and client knowledge. You will provide direction and oversight of staff personnel and team objectives.Some key capabilities you should be… more
- NJ Transit (Newark, NJ)
- Manager , Project Oversight & Compliance Capital Programs Job Description: Move forward with us! At NJ TRANSIT, you'll join us in transforming the ... it all possible. Summary: The solutions and detailed oriented Manager , Project Oversight & Compliance is responsible for ensuring Capital Programs staff… more
- State of Georgia (Fulton County, GA)
- Office of Intermodal- TRM032, Mgr. 3, Transport Specialist (PG-R) "State Safety Oversight Technical Manager " Atlanta GA Georgia - Fulton - Atlanta ... or more areas listed. Position Specific Duties: State Safety Oversight Technical Manager provides advanced assistance to...to meet the requirements of the FTA's State Safety Oversight regulations, and assure compliance with the… more
- Citigroup (New York, NY)
- …senior function/business/product compliance risk manager for Independent Compliance Risk Management (ICRM) Fraud Oversight coverage including all ... a manner consistent with the Citi program framework. **Responsibilities:** + Providing ** compliance coverage for Fraud Operations providing oversight over USPB,… more
