- Insmed Incorporated (Brooklyn, NY)
- 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
- 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)
- …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
- Eisai, Inc (Nutley, NJ)
- …responsibilities.Ensures the timely and appropriate collection, organization, and analysis of diverse data sources (eg, clinical trial data , patient ... The incumbent will assume a crucial role within the Global Value & Access (GV&A) team, responsible for leading...statistical methodologies and their application in the context of non- clinical studies and related projects in AD and other… more
- Merck & Co. (Rahway, NJ)
- …in a timely manner and in coordination with the studyCRM and CRA.Interface with GCTO( Global Clinical Trial Operations) partners on clinical trial execution ... quality standards internally and externally.Under the oversight of the CRD( Clinical Research Director) / Director, Clinical Research, the individual is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …vendors to ensure study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data is suitable for ... 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)
- …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. (Rahway, NJ)
- …forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug ... Job DescriptionOur Company is a global health care leader with a diversified portfolio...Substance, Drug Product, Analytical Development, and Clinical Supply across all modalities. We are interdependent across… 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)
- …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)
- …be the Clinical Science Group Lead in late phase development in the Global Clinical Science functionHe/she will be responsible for managing the multiple ... (writing of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus...in Clinical Development, Asset & Portfolio Management, Global Clinical Operations, BDM and DLT membersHe/she… more
- Eisai, Inc (Nutley, NJ)
- …strengthen compliance with GDPR, HIPAA, CSL, and other relevant security and data privacy standards . Your responsibilities span security operations, risk ... optimization. Essential Functions: Partnerships and Business Relationships:Promotes awareness of standards related to security, regulatory, clinical , commercial,… 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)
- …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
- 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)
- …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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …applications and best practices as well as strong technical skills in working with ( clinical ) data . The position holder will require strong skills in continuous ... Contribute to raising and maintaining awareness of best practices for reproducible data science, global regulatory requirements, internal guidelines and Standard… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …stakeholders ( Clinical Operations, Clinical Biomarkers, QCP, etc.) for establishing data collection, data standards and data cleaning needs ... in line with agreed upon EFTs, eDTS, DS External Data Standards and Contract/SOW.Promotes Daiichi Sankyo values...is required.Knowledge of CDISC and SDTM and industry standard data collection practices. Clinical data management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunities in order to support best in class sourcing and procurement for Global RD - for their specific categories.- Data Analysis Based Decision-Making- ... of clinical trials preferred- Demonstrated ability to leverage digital data and analytics preferred- Demonstrated ability driving or participating in digital… more
