- 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
- 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
- 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
- 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)
- …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
- 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
- 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)
- …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
- 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
- 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
- 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)
- …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)
- …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
- 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
- Aequor (New York, NY)
- …an occupational nursing professional Minimum experience of 1-3 years in case management , utilization review and/or quality assurance Experience in episodic care, ... counseling of adults Proficiency in use of electronic medical record keeping systems desirable BLS certification required Optional: Case Management and COHN-S… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWith support of Sr CRA/CRA and/or CRA Manager , acts as primary site contact and site manager -throughout all phases of a clinical research study, ... relationships through all-phases of the trial.Performs clinical study site management /monitoring activities in compliance with ICH-GCP,-Sponsor SOPs, Local Laws &… more
- Merck & Co. (Rahway, NJ)
- …hardware and software vendors in order to set global standards and perform lifecycle management of bar code printers and software systems . The engineer will also ... Engineer will be responsible for evaluating, recommending, implementing and supporting systems in the manufacturing and lab print environment including label and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to help the team, in a manner consistent with safety policies, quality systems , and cGMP requirements. Support manufacturing investigations, create/revise ... forms, and support and manage change controls. Work closely with Operations Manager to help oversee the development of production personnel, provide input on… more
- EY (New York, NY)
- …exceptional experience for yourself, and a better working world for all.Consulting Services Manager , AI & Data - Master Data Management EY delivers unparalleled ... in the areas of Data Strategy, Data Governance, Data Quality , Data Definition and Usage, and Data Management...(Extract, Transform & Load) to move data from disparate systems to Master Data Management Hub. Knowledge… more
