- 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 ... abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery role, reporting… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: HVAC Operations Manager Reporting to the Associate Director in HVAC, the HVAC Operations Manager will be part of the ... 24-hour operations team for the site.- The Manager will direct a team of hourly personnel who are accountable for the 24-hour operations of the site.- The … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Global R&D PV QA Leadership members as well as Head Global Strategy & Operations (RDPVMA QA). This position also performs support tasks in which incumbents are ... in database and research tools.ResponsibilitiesSupport the Head Global QA strategy and operations (RDPVMA QA)on projects needing to be coordinated with both DSI QA… more
- Merck & Co. (Rahway, NJ)
- …internally and externally.Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and ... Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).Responsible for project management of the assigned… more
- Merck & Co. (Rahway, NJ)
- …of low or non-performance.The role will work across the different country operations roles (eg CRM(Clinical Research Manager ), CRA(Clinical Research Associate)- ... individual is responsible to-manage/oversee a team of CTCs(Clinical Trial Coordinator).As line manager the role is critical to continuously develop future talent by… 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 ... successful outcomes. The role will oversee M&E vendor training programs and initiatives. The role will be crucial to enhancing participant experiences, streamlining… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help ... of 5 years' experience in pharmaceutical or biotechnology across clinical trial operations . Experience in training , process improvement, and project management… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities ... existing systems in Regulatory AffairsRequired Skills5 years of Regulatory Operations experienceExtensive knowledge and experience with Microsoft Office, Adobe… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …team member with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical support to the CSL ... and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data… 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 ... archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key study documents to the CRO and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to staff, within the Trial Management (TM) function of North America Clinical Operations (NACO). Takes ownership to position & deliver upon near & mid-term NACO ... studies within the clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North America Clinical Development (NACD). Manages mutually… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …methodology in accordance with current regulatory guidelines.- Provide appropriate training and guidance on global DX computer system validation procedures ... and qualification and Computer Software Assurance (CSA), SDLC related to pharmaceutical operations . required- 1 or More Years Direct dealings with FDA, EMA, PMRA,… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems ... (CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, quality operations , etc. Responsibilities:Assures compliance with all SOPs, cGMP, FDA, as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …clinical development/trial experience within a pharmaceutical, biotechnology, or CRO required. Training & Development, Operations and/or Learning and Development ... a living. Are you ready to make a difference? The Position Develop role-based training curricula for CMR function to ensure quality and compliance in accordance with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to storage and distribution of product by sales representatives and supporting training relative to proper handling of product by sales representatives. This ... routine networking through membership in industry association(s). Essential Functions Sales Operations Partner Drive value creation and link quality to business by… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical Operations ... based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction and leadership… more
- Merck & Co. (Rahway, NJ)
- …a roadmap of prioritized improvements to our infrastructure (eg knowledge management, training , and enabling systems) and drive initiatives on that roadmap that ... include: Key Responsibilities PMO owner and steward of "Development Project Manager " user persona; accountable for defining business process user stories and… 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. As a project ... manager this position is accountable for partnering with the...Team and Global Clinical leader to ensure effective team operations through meeting management, development plan/timeline management, scope management,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … sessions - both live and virtualTrack speaker utilization and work with manager to escalate as needed.Coordinates Speaker Training and working closely with ... programs. Responsible for maintaining speaker profiles, creating and delivering training materials and content on the speaker engagement platform.ResponsibilitiesProgram… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …external vendors by engaging with key cross-functional stakeholders (Clinical Operations , Clinical Biomarkers, Precision Medicine, etc.) for establishing data ... vendor selections and work alongside DS Procurement and DM operations to qualify preferred data vendors to ensure DSI...data management subject matter expert and provides guidance and/or training to study teams in preparation for upcoming audits.… more
