- 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
- 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)
- …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
- 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)
- …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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The AD, Global Clinical Operations (GCO) Clinical Trial Operational Risk (CTOR), will ... in due diligence activities during the vendor selection process.Close partnership with clinical quality management, SVO and other compliance functions within and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as team member with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical support to ... quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Performs literature review and creates reference… more
- Merck & Co. (North Wales, PA)
- …/scientific execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on a clinical trial team.Leading medical ... protocol in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and… more
- Merck & Co. (Rahway, NJ)
- …ideas and innovative solutions that enable new capabilities and technologies. As the Clinical Supply Delivery Lead for our research organization, you will be ... responsible for delivering SAP solutions to our Research Organizations' Global Clinical and Ancillary Supply-user community. You will p articipate in interviews with… more
- Merck & Co. (Rahway, NJ)
- …and innovative solutions that enable new SAP capabilities and technologies. As the Clinical Manufacturing Delivery Lead for our Research & Development Division , ... you will be responsible for delivering SAP solutions to our Global Clinical Manufacturing user community. You will p articipate in interviews with our company's'… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all Global ... in trial operations and management.Monitor and ensure compliance and highest quality standards in all GOMA clinical operational activities. Support the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …investigators is expectedThe CS Group Lead will also ensure the writing of high- quality clinical trial protocols, review of clinical data and Clinical ... veterans and people with disabilitiesSummaryThis position will be the Clinical Science Group Lead in late phase... Clinical Development, Asset & Portfolio Management, Global Clinical Operations , BDM and DLT membersHe/she will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Clinical Operations , Regulatory Affairs, Data Management, Biostatistics, Non- clinical , Medical Affairs, Marketing, Legal, Quality , and other affiliates. ... MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D… more
- Merck & Co. (Rahway, NJ)
- …engineers & chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of ... (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. The… more
- Catalent (PA)
- Proposal Lead I Summary Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to ... Biologics is positioned to drive significant growth for Catalent.The Proposal Lead I works closely with Business Development (Sales), Program Management, and… more
