- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary The Manager, Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible to support ... experience in pharmaceutical or biotechnology in clinical trial operations or clinical quality assurance. required Experience Qualifications4 or More… more
- Merck & Co. (Rahway, NJ)
- … Research Director(s), the Sr CCQM Lead establishes and/or - local clinical Quality Management System (CCQMs) aiming to achieve the organizational strategic ... Lead supports large to medium size country/cluster clinical trial operations to achieve those objectives....-The role requires the ability to properly oversee and/or lead local quality operations to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Summary This position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role is primarily responsible for ... service providers and working with internal departments to progress clinical supply projects. Every effort has been made to...the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director, Clinical Operations on plans ... Responsible for management of compounds at the program and franchise levels. May represents Clinical Operations on the Strategy and Portfolio or Clinical Sub… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan including ... site qualification process.Monitor clinical trial performance and quality metrics and share with study team, Operations... quality metrics and share with study team, Operations Program Lead , and Sr. Director for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including critical path ... site qualification process.Monitor clinical trial performance and quality metrics and share with study team, Operations... quality metrics and share with study team, Operations Program Lead , and Sr. Director for… more
- Insmed Incorporated (San Diego, CA)
- …laboratory unit to ensure efficient and effective scientific and administrative operations . Operates, maintains, and repairs clinical laboratory equipment within ... as quality initiatives and therapeutic area training (TAT).Oversees daily operations in the laboratory with respect to troubleshooting instrumentation, out of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders.Summary The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions in the West, in ... adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food...functional integration and delivery of items (eCRF, EDC, IXRS, Quality Oversight Plan etc) per the study plan. Oversee… more
- Merck & Co. (Philadelphia, PA)
- …strategic direction, and overall performance of the eSSC. Ensures sound clinical development principles are incorporated into the services provided by the ... eSSC. Ensures consistent, high quality and standard processes are complied with, and meet...external stakeholders and partners to align cross functional strategy, operations and execution related to eSSC services provided.Align with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Director, Global Clinical Operations (GCO) Clinical Trial Operational Risk & Oversight ... for risk and issue management with strategic development partners.Close partnership with clinical quality management and other compliance functions within and… more
