- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Study Team (IST) representative or IST leader on study team; Responsible before senior management for the creation and execution of development strategies for ... Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior … more
- Catalent (San Diego, CA)
- …and escalation of quality issues to Site Leadership Team and QA senior management .Lead programs for: QA department budget, Site Training, Supplier and ... CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies...the development of site Quality Objectives, site Quality Plans, Quality Management Reviews,… more
- Insmed Incorporated (Bridgewater, NJ)
- …to the transition of the TMF to Insmed at end of study. Partner with Quality Assurance team to help clinical study team with audits/inspections for CRO/vendors ... and Best Workplaces for Millennials™ lists.OverviewAssist in the delivery of Clinical Operations objectives by providing operational support to the clinical… more
- Eisai, Inc (Nutley, NJ)
- …Plan and monitors study conduct to proactively address issues to ensure high quality study data (as needed). Clinical Study Report - provides statistical and ... we want to hear from you. Job Summary The Senior Manager, Translational Science Biostatistics will be expected to...across programs, as well as the study statistician for clinical studies. As the statistical lead for biomarker development,… more
- Tris Pharma (Monmouth Junction, NJ)
- …Fosters a culture of quality -by-design in trial oversight and risk management across outsourced clinical trials, ensuring efficient issue resolution, risk ... study processes and procedures ensuring timely execution of quality clinical trials complying with all regulations...of issues for trial or program level deliverables to senior management , etc.); Develops, implements, and/or manages… more
- Eisai, Inc (NJ)
- …provider business relationships in alignment with global strategies.Review and approve Clinical Quality Assurance audit plans and reports.Review and respond ... Essential Functions Oversee outsourcing requirements for phase I-IV global clinical trials including functional services.Accountable for vendor management ;… more
- Eisai, Inc (NJ)
- …As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of ... we want to hear from you. Job Summary The Senior Manager, Medical Writing will be the designated Lead...the compounds' life cycle management , with support from management as needed.… more
- Merck & Co. (North Wales, PA)
- …project management skillsDemonstrated success in the assurance of deliverable quality and process compliance.Familiarity with statistical and clinical data ... and external stakeholders including Statistical Programming, Statistics, Regulatory, Data Management , Clinical and other project stakeholders.-Primary ResponsibilitiesSupporting… more
- Merck & Co. (Rahway, NJ)
- …a fast-paced job that provides a high degree of technical and project management responsibility. The Senior Specialist - Manufacturing Automation position will ... Quality SystemsExperience in supporting compliance investigations and change management .Familiarity with US and EU GMP and Safety compliance regulationsEffective… more
- Merck & Co. (Rahway, NJ)
- …trial level. Primary activities include, but are not limited to: All responsibilities of a Senior Clinical Data Manager (SCDM) and a Clinical Data Manager ... Job DescriptionUnder the direction of the applicable management , the Lead Clinical Data Manager...Standard Operating Procedures (SOPs) and ICH-GCP guidelines. Works with management to maintain the consistent execution of quality… more
- Eisai, Inc (Nutley, NJ)
- …business decisions. Can apply financial analysis to build business cases that drive quality decision making and management processes.Travel is estimated at 30% ... this is your profile, we want to hear from you. Senior Manager, US Alzheimer's Strategy and Lifecycle Planning Marketing...and logistics associated with the congress experience.Assist with the management of the brand plan dynamic dashboard to drive… more
- Merck & Co. (North Wales, PA)
- …drug/vaccine projects under supervision in Late Development Statistics. --Interacts with Clinical , Regulatory, Statistical Programming, Data Management and other ... these analyses.Prepares oral and written reports to effectively communicate results of clinical trials to the project team, management , regulatory agencies, or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …operational considerations Clinical representative of executive teams including, the Quality Counsel, Executive Safety Committee, GxP Risk Management Team, ... Domestic and international clinical trial execution experience required Post-approval clinical management experience a plus Direct management experience… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …communication between CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL ... to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …resolve, for example across various topics, such as clinical trial management , deviation handling, and product quality Develop, execute, and maintain ... Responsible for upholding and promoting the Novo Nordisk (NN) Quality Management System (QMS) as the framework... system Conduct GxP quality visits at clinical trial sites when directed by management … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …design, operational planning, start-up, conduct, reporting, and close out) including timeline, quality , and budget management Drives and leads the successful ... components of a large-scale global clinical program using strong clinical project and program management , leadership, decision-making ability, people … more
- Aequor (Thousand Oaks, CA)
- …top end of the experience level. Ideally candidates who have strong project management experience as well as product development experience (Have skills such as lean ... better, can be a hands off leader, candidates who have familiarity with Pharma; Clinical Trials. Qualities an ideal candidate possess that will work well with the… more
- Merck & Co. (North Wales, PA)
- …be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM ... This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more… more
- Novo Nordisk Inc. (Boulder, CO)
- …and Cambridge reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct ... merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both...you ready to make a difference? The Position The Senior IT Engineer I - Labs will be responsible… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific ... in other trial-level development forums.Under the guidance of more senior staff, may serve as the data management...the development of, and ensures adherence to, our company's clinical data management procedures. Interacts with staff… more
