- Tris Pharma (Monmouth Junction, NJ)
- …success. Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager ... and objectivesOversee and manage the maintenance and tracking of Quality Systems including, but not limited to... principles in the design (and resolution) of key quality management system elements to ensure complianceTracks… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …trials improvement/innovation projects for NACD & Novo Nordisk (eg, Health Systems , Contract Research Organizations & Site Management Organizations etc.) ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....Position Provides tactical leadership to staff, within the Trial Management (TM) function of North America Clinical Operations (NACO).… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management , is accountable for an end-to-end ... on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse...the collection of diverse external data types.Advises Study Data Manager on complex vendor management issues and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Associate Manager will support CMR's partnership and alliance contract management strategy with a focus on: Partnering with stakeholders across CMR to plan, ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Merck & Co. (Rahway, NJ)
- …these guidelinesExpertise in and excellent working knowledge of core trial management systems and tools.Strong coordination and organizational skills.High ... these commitments within specified-timelines with minimal oversight from the line manager .-Ability to proactively develop risk management and mitigation plans… more
- Merck & Co. (Rahway, NJ)
- …and training needs to CRA manager and/or functional vendor and internal management as needed. Performs Quality control visits as required. Leads local study ... DescriptionThis role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP… more
- Merck & Co. (Rahway, NJ)
- …modalities. We are interdependent across our functional areas, Discovery, our Manufacturing Division Quality , and BARDS, to name a few, and with our partners in ... so everyone can bring their whole self to work.Within DSCS, the Digital Program Manager will advance the purpose and aspiration of our Company 's DSCS Digital… 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 ... responsible for agile execution and support of new capabilities, platforms, and systems within Novo Nordisk in partnership with internal stakeholders and external… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …plans.Accountable for accuracy and timeliness of information in all data management activities, databases and tracking systems .Company Sponsored Studies (CSS) ... milestones as per contract). Ensure the global clinical operations systems for management of company sponsored studies...and tools to achieve excellence in trial operations and management .Monitor and ensure compliance and highest quality … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …EU preferred)2 or more years Familiarity with pharma and regulatory information management systems (RIMS); Veeva Vault experience preferred. Travel Ability to ... rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global...quality of data across key Daiichi Sankyo regulatory systems . This includes defining regulatory data standards, data … 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 ... Remote This position is responsible for the supply planning and inventory management of clinical supplies required to support global clinical research and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the maintenance of the GCO training curriculum in collaboration with Clinical Quality Management and/or QA, as appropriate.-Participate with the identification ... areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Plans, Protocols (IQ/OQ/PQ), Test Scripts and Summary Reports.Support the change management process for validated systems where necessary.Maintain effective ... DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP and Non-GxP activities, assuring that these systems … more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. ... As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the development and implementation of new processes, procedures and/or systems to improve organizational efficiencies and cost controls.Communication and ... Relationship Management - Leads contract related communication with vendors. Respond...spend category that reduces costs, reduces timelines and improves quality . Coaches and mentors' colleagues on the outsourcing process… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Senior Manager , Translational Science Biostatistics will be expected to work independently with minimal ... TLG shells and specifications of variable derivation.Monitoring - develops Study Quality Surveillance Plan and monitors study conduct to proactively address issues… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities related ... In addition, this individual will be responsible for general document management activities relating to the archiving of submission and submission related… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …administration of validated electronic systems such as LMS or other quality management systems .- Strong interpersonal, communication, negotiation and ... units or Global project teams. This position has advanced skills in technology systems , including word processing software and data management software, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …network to influence across the organization.Manages project status in the project management information systems and communicates risks/issues to GPM senior ... project or be partnered with a more senior project manager in support of a larger, more complex drug...drafts stage gate proposals for formal presentation to senior management .Generates and maintains high quality risk … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …builds and maintains positive relationships with internal/external stakeholders/vendors/partners. - Project Management : Is accountable for quality of delivery in ... quality of external data, transfer standards, and issue management . Ensure consistency of standard implementation across programs. Is...as an extended part of committee. Advise Study Data Manager on complex vendor management issues and… more
