- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... More Years relevant experience is required with a BSc requiredExperience in clinical operations methods and processes in industry setting requiredExperience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requiredMaster's Degree preferred Experience: Minimum of 5 years of Global Clinical Trial experience in the device/pharmaceutical/CRO industry required.Expertise ... This position reports to the Associate Director Data Management Operations . Business administration activities within the CDR...This position will also work with members of Data Operations , DM, and Biostatistics, Clinical Study teams,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …acquisition, validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements ... are crucial for this role. Advanced knowledge of Data Management, Biostatistics, Clinical Operations , Pharmacovigilance, handling and processing of raw data and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by Design (QbD) and Risk-Based Quality Management (RBQM) approach to clinical trial conduct. Major focus is on operations concerning risk control and ... Statistical Monitoring during study conduct to detect oddities, trends in clinical variables, or site differentials, following the critical variables defined during… more
- System One (Parsippany, NJ)
- Clinical Trial Associate Parsippany NJ, 07054 (Onsite 5 days a week until ramp up and then flex on Fridays) Contract position slated through 2025 + Assists the ... day-to-day operational activities and other specific projects as assigned within Clinical Operations , including communications with cross-functional teams and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with the CRO and the study team. Oversee the site qualification process. + Monitor clinical trial performance and quality metrics and share with study team, ... are equally important. Outside interfaces may include other Daiichi-Sankyo business groups and subsidiaries in the US and abroad,...is required with a BSc required + Experience in clinical operations methods and processes in industry… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …phase 4 and registry studies, working with other internal stakeholders including clinical operations , statistics and regulatory. + Provides scientific and ... scientific and medical activities with other internal stakeholders (ie, commercial, clinical operations , statistics, regulatory, etc.) as they relate to… more
- J&J Family of Companies (Raritan, NJ)
- …in the development of the EGS / EDS + Develop and draft clinical trial protocols, informed consents, investigator brochures, and other study materials ... supervision + Plan for study budgets and collaborate with Clinical Operations to manage the development of...product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …TA Operations leadership + Identify and implement opportunities for innovation within clinical trial operations and identifies trends or competitors in ... one of more therapeutic areas in Clinical Trial Management (CTM). The Executive Director TA Operations...impose undue hardship on the operation of the Company's business . For roles in which the hired candidate will… more
- Sanofi Group (Bridgewater, NJ)
- …project strategy, its endorsement by governance and its execution in close collaboration with clinical operations . The CRD is expected to advance scientific and ... with the global project team and internal partners such as clinical operations , translational medicine, regulatory affairs, biostatistics, drug discovery,… more
- Amneal Pharmaceuticals (Bridgewater, NJ)
- …agreement requests and support for Manufacturing and Supply Chain, R&D, Clinical Operations , Regulatory, Corporate Procurement, Facilities and Administrative ... The Sr Director, Corporate Counsel - Corporate & Commercial Operations is an integral member of the legal team...to review of sales and promotional materials. + Handle clinical trial and REMS contracting + Supervise… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …by Design (QbD) and Risk-Based Quality Management (RBQM) approach to clinical trial conduct. Major focus is on operations concerning risk control and ... Statistical Monitoring during study conduct to detect oddities, trends in clinical variables, or site differentials, following the critical variables defined during… more
