- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Manager, Operations and Reference Data Management, Global Clinical Data Standards Working closely with the ... Global Clinical Data Standards (GCDS) Sr. Director of Operations and Reference Data Management within the Global Data Management & … more
- Merck & Co. (Rahway, NJ)
- …of our existing and pipeline products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate ... processes for growth opportunitiesThe Vocabulary Specialist may lead or participate in:Internal clinical data standards forumsStandards development teams and… more
- Insmed Incorporated (Columbus, OH)
- …to the highest standards The Therapeutic Specialist will possess a high clinical aptitude and seasoned experience in a portfolio environment to ensure the voice ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...Company policy and procedures Demonstrate high ethical and performance standards with all business contacts in order to maintain… more
- Insmed Incorporated (Westerville, OH)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... mission to transform the lives of patients. They must possess a high clinical aptitude and experience in portfolio selling environment to engage key customers. Along… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Specialist, Clinical Operations Global Clinical Trial Operations (GCTO) is a global organization operating in over ... of our company's diverse development portfolio comprising over 200 clinical trials in compliance with global and...team player and ability to work independently in a global setting Microsoft Office and data analytics… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a medical device, pharmaceutical company, or similar environment (eg, CRO) requiredExperience with clinical data standards requiredDaiichi Sankyo, Inc. is an ... This position also partners with internal and external stakeholders to optimize Data Management technology, processes, and standards .This position has a working… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is to oversee bioanalysis strategy from global development and global regulatory perspectives, set standards (industry best practices), ensures efficient ... head of regulated bioanalysis will also form strategic internal (DMPRL, Clinical Operations, Data Management, Scientific Operations etc) and external… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution ... Global review, tracking of milestones as per contract). Ensure the global clinical operations systems for management of company sponsored studies review… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Executive Director, Global Clinical Operations Study Management Group Head has leadership ... study management and delivery for all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for ensuring the clinical… more
- Merck & Co. (North Wales, PA)
- …heavily relies on accurate data collected from patients who are part of Clinical Trials. Trial Standards , Trial Design, Trial Data Collections, Trial ... trial participants, in the right way to enable the Clinical Research to analyze data for efficacy,...initiation to first site ready.Remove obstacles and enable the Global Clinical Trial Organization to focus on… more
- Merck & Co. (North Wales, PA)
- …to work independently in a global setting.Microsoft Office and data analytics proficiencyPreferred:Prior work experience in clinical outcome assessment ... in the delivery of our company's diverse development portfolio comprising over 200 clinical trials in compliance with global and local regulations. The Regional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of data across key Daiichi Sankyo regulatory systems. This includes defining regulatory data standards , data quality rules and data governance ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi... data governance activities (eg developing and implementing data standards )3 or more years' Experience working… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as ... to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment… more
- Merck & Co. (North Wales, PA)
- …and statistical analysis methods fundamental to effective pharmaceutical R&D.- The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment, ... Lead and provide statistical support for related drug/vaccine projects in Clinical Safety StatisticsInteract with Safety Physicians, Safety Scientists, Clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs ... creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs...EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …individual assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, ... Global Product Team or specific sub-teams such as clinical study team and submission team, providing the safety...serving as the primary point of contact.Review and analyze data from clinical trials, post-marketing and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …have to lead a complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing life-cycle strategy. ... all external information of the program, including publications, regulatory documents, clinical trial registers, data release, etc. Accountable for protecting… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJoin our team as a Clinical Quality Operations Lead - Inspection Strategy and be at the forefront of developing and implementing policies, processes, ... with other functions within and outside of GCTO to ensure that Good Clinical Practice Health Authority inspections are adequately supported and managed and that QCO… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …function as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, Global Brand Team, and Global ... to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
