- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … and CRO and vendors levels) and/or issues / risks are escalated to project team level and relevant governance bodies.Triage, resolve or escalate study issues ... and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key internal and external… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a lower complexity or regional project or be partnered with a more senior project manager in support of a larger, more complex drug development project . ... level objectives and may also participate on a non- project initiative in support of these objectives. This position...more complex projects in collaboration with a more senior project manager . Establishes and maintains a high… more
- Aequor (Raleigh, NC)
- Remote Position - Flexible Hours Manager is open to seeing candidates with a minimum of 3&plus years of relevant working experience. Technical skills: advanced Excel ... clinical development process knowledge. Job Details: Manages one or more high- level , complex non-technical projects within the constraints of scope, quality, time,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …lead a team of API Optimization Specialists, Manufacturing Area Specialists, and Project Managers in the execution of the manufacturing suite robustness and capacity ... capacity. Responsibilities include team development, delivery of the associated project portfolio, status reporting, budgeting, training and planning. The role… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Trains, develops & engages staff as required across NACD by assuring training plans (NACD level & project level ) are developed & deployed within a staff ... to staff, within the Trial Management (TM) function of North America Clinical Operations (NACO). Takes ownership to position & deliver upon near & mid-term NACO… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …management. ResponsibilitiesLeadership, Direction, and Strategy:Establishes Data Management strategy at the project and/or study level for a smaller number of ... projects/studies Proactively identifies and manages risks at the project and/or study level for a smaller number of projects/studiesProject Management:Plans and… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …DCA audits and prepare and file all necessary governmental regulatory reports and plans.The Manager will also oversee the daily operations of the LBRI Office of ... Director of Research Administration and under limited direction, the Contracts Manager - Federal Contracts and Compliance, will oversee end-to-end contract… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The Manager , NextGen Customer Engagement will support Novo Nordisk's strong commitment to its customers ... & Marketing Enablement functions (Omnichannel Engagement, Field Systems, Marketing Operations ) and other NNI functions (Marketing, Advanced Analytics, IT) to… more
- Novo Nordisk Inc. (Boulder, CO)
- …the Department The Boulder Site is home to the specialized technical operations /CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the ... process development, the CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early Development professionals at our Boulder, Colorado… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …maintaining innovative technology solutions for Meetings and Events, ensure smooth operations , and collaborating with vendors to optimize services and achieve ... selection process- Collaborate with vendors to define and manage service- level agreements (SLAs), ensuring compliance and high-quality service delivery- Monitor… more
- Merck & Co. (Rahway, NJ)
- …groups in alignment with the sales management team and commercial operations groups.--Additionally, this position will stay abreast of the external environment ... skills, be an expert relationship builder (internal and external) and project a natural executive presence.--The ideal candidate partners with cross-functional peers… more
- Aequor (NJ)
- 100 % remote Manager prefers local candidates (will consider non local candidates as well) Required bachelor's degree Must Haves: Phase 1 to 4 clinical trial ... Clinical Research and Development, Global Study Management and Monitoring (GSMM), Project Management, Client Affiliates, Medical Affairs (MA), Regulatory, CMC, QA,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Finance and Operations dept. brings insights and intelligence to inform decision making & drives digitalization and business solutions to ... attain NNI goals. Finance and Operations works closely across the organization to guide enterprise-wide...maximize your potential with us? The Position The Senior Manager , Commercial Insights & Analytics, provides insights and analytics… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... preferable. Responsibilities Leadership, Direction, and Strategy:Leads implementation of Program/Therapeutic level external data collection requirements by partnering will internal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process ... as well as cross-functional stakeholders (eg, RA CMC, R&D Excellence, Clinical Operations , IT).Responsibilities Operate within and in support of the established RD… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good Clinical Practices ... support to study teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo… more
- Eisai, Inc (Nutley, NJ)
- …15 years related work experience, including at least 5 years of enterprise- level governance and management.Certified Information System Manager (CISM), Certified ... security and data privacy standards. Your responsibilities span security operations , risk assessment, investigations, and compliance issue resolution for the… more
- Merck & Co. (Durham, NC)
- …meet performance objectives.Escalates and consults on an as-needed basis with next level manager on more complex decisions impacting critical milestones. ... manage team and assignments.Ensure all assigned aspects of the incoming and operations process proceed in compliance with cGMP, applicable regulations, and our… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Service Level management reporting. This role will liaison with operations and other support groups regarding system use, and interfaces with business ... About the Department The Finance and Operations dept. brings insights and intelligence to inform...and ensure alignment Ensures that vendors are adhering to project or service level agreement timelines and… more
- BioAgilytix (Boston, MA)
- …for second- level technical reviews of documents prior to review by the project manager (eg, Bioanalytical Project Manager (BPM), Principal ... and long-term objectives. Playing a pivotal role in our project lifecycle, you'll conduct validation studies on a spectrum...review of data and documentation generated by the Bioanalytical Operations group in support of regulated studies (eg GLP,… more
