- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …device, pharmaceutical company, or similar environment (eg, CRO) required + Experience with clinical data standards required Daiichi 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… 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 ... 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)
- …centered around rare diseases and immune disorders. **Summary** The Executive Director, Global Clinical Operations Study Management Group Head has leadership and ... 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
- Kedrion Biopharma, Inc. (Fort Lee, NJ)
- …in hematology, immunology, neurology, and transfusion medicine. The **Vice President of Global Clinical Development and Strategy** will report into an Executive ... individual clinical trials + Collaborate with Kedrion Global Clinical Research teams to drive scientific...+ Maintain current knowledge of strategic trial design and data generation to include registries and real-world data… 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
- Actalent (Morristown, NJ)
- …of their drug candidates are invented and developed in house! Description: + Clinical Data Manager who will work collaboratively with vendor Project Managers ... and Clinical Data Managers to assure that ...according to company SOPs and in compliance with Company's data standards . + Serve as primary DM… more
- Rockefeller University (New York, NY)
- …regarding the clinical research study + Collect and process research data and specimens as needed/required + Provide assessment skills and direct nursing care ... of both the virus and our antibodies. Overview The Clinical Research Nurse will be responsible for coordinating and...through the development or updating of protocols, procedures, and standards for a study in collaboration with the primary… 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'… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …be the Clinical Science Group Lead in late phase development in the Global Clinical Science function. He/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 members.… more
- Merck (Rahway, NJ)
- …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,...first site ready. + Remove obstacles and enable the Global Clinical Trial Organization to focus on… more
- Merck (Rahway, NJ)
- …+ Develop, update, and maintain GCP inspection procedures and guidelines within Global Clinical Trial Operations (GCTO). + Contribute to the development ... . It is business critical that our Company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. In partnership with the … more
- Abbott (Manhattan, NY)
- …other clinical site management colleagues and supports key projects/initiatives in Global Clinical Operations and/or Business Units. **What You'll Work On** ... Monitors to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive of...sites for accuracy and completeness + Facilitate resolution of data queries and action items at 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
- Edwards Lifesciences (Newark, NJ)
- …. **How you will make an impact:** + Design, create, validate, and modify clinical databases, and tools and programs for data validation checks, and ... in the design and delivery of moderately complex functional modules and provide data management expertise regarding clinical trials, protocols, and case report… 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
- Actalent (New York, NY)
- …Ensure compliance with regulatory guidelines, Good Clinical Practice (GCP) standards , and study protocols related to data management activities. + ... plays a pivotal role in ensuring accurate and timely data management for clinical trials. This role...Experience Level: Expert Level About Actalent Actalent is a global leader in engineering and sciences services and talent… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …& Medical Affairs, Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs, Pharmacovigilance) Strategy/Portfolio Management, Global ... Job Title Senior Director, Clinical Development & Medical Affairs (CDMA) Requisition JR000014103...programs, ensuring they meet the highest scientific and regulatory standards . The Senior Director will also play a key… more
- STERIS (New York, NY)
- Clinical Perioperative Liaison Req ID: 43006 Job Category: Service/Technical Services New York City, NY, US, 10021 Description: At STERIS, we help our Customers ... responsibility of the Perioperative Support Liaison is to provide integrated clinical and technical on-site Customer support, consultation, and management of medical… more
- ThermoFisher Scientific (Newark, NJ)
- …that people and communities depend on - now and in the future. Our global Clinical Operations colleagues within our PPD(R) clinical research services ... meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission...letters in a timely manner using approved business writing standards . Escalates observed deficiencies and issues to 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