- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study… more
- 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
- George Washington University (Washington, DC)
- I. JOB OVERVIEW Job Description Summary: The Senior Applications Administrator, Clinical Research Programs functions as the Subject Matter Expert for Clinical ... the GW SMHS and reports within the Office of the Dean. This includes the Clinical Trial Management System (CTMS)-Oncore (TM) , Eval, Oncore (TM) - Electronic… more
- Merck & Co. (Rahway, NJ)
- …this valuable insight, you will provide feedback to senior management and drive continuous improvement initiatives. Quality Improvement Champion:-Act as an ... Job DescriptionJoin our team as a Clinical Quality Operations Lead - Inspection...inspections. Your expertise and guidance will ensure the smooth management , training, and support of regulatory Health Authority inspections,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Manager, Operations and Reference Data Management , Global Clinical Data Standards Working closely with the Global ... and provide insights into implementation of strategic direction.In support of the Senior Director, Operations and Reference Data Management , ensures project… more
- Merck & Co. (Rahway, NJ)
- …standalone, laboratory instrument systems and manufacturing automation systems.Endorse and build Quality Management System elements into the end-to-end computer ... organization and for the company's R&D division.For company's Clinical Supply, act as the Quality Unit...and testing.Act as a liaison with respect to the Quality Management System and Compliance pillars of… more
- Merck & Co. (Rahway, NJ)
- … Clinical Research Associate - Northeast Region (Remote) With support of Senior Clinical Research Associate (SrCRA/CRA) and/or CRA Manager, acts as primary ... continuity of site relationships through all phases of the trial.Performs clinical study site management /monitoring activities in compliance with ICH-GCP,… more
- 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
- Merck & Co. (Rahway, NJ)
- …how to appropriately raise issues and drive discussion within peer groups and with senior management .-Demonstrated courage of conviction - able to speak up / ... contribute to all circles; comfortable challenging ideas or proposals, including senior management .-Brings forward creative ideas and contributes to setting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …external investigators is expected. The CS Group Lead will also ensure the writing of high- quality clinical trial protocols, review of clinical data and ... function. He/she will be responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior...will include but not limited to Group Heads in Clinical Development, Asset & Portfolio Management , Global… more
- Carolinas ContinueCARE Hospital at Pineville (Charlotte, NC)
- …to quality assurance- Provide guidance and support to staff regarding quality improvement initiatives- Collaborate with medical management to ensure ... Responsibilities:- Develop and implement quality improvement strategies.- Ensure compliance with all regulatory requirements and standards Ensure survey readiness. -… 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
- 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
- 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
- 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
- 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. (Rahway, NJ)
- …design and monitoring of clinical programs and studies, producing high- quality clinical documents and presentations.Collaborate with functional area leaders ... Job DescriptionAs a key member of the General Medicine Global Clinical Development team, the Vice President/ Therapeutic Area (TA) Head's primary objectives will be… more
- Catalent (Harman, WV)
- Senior Director, Supply Chain Position Summary: The Senior Director, Supply Chain is responsible for leading the supply chain organization for Catalent Maryland. ... suites coming online.Reporting to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply chain management… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a Senior Manager/Associate Director, External Manufacture as part of the Global Manufacturing Supply ... position will be responsible for managing the technical transfer and clinical /commercial manufacture of cell therapy products in our external manufacture… 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
