- 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
- 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
- Merck & Co. (North Wales, PA)
- …topics and SOPs, the Global Clinical Development (GCD) Standards & Training Lead (STL) will work closely with Quality and Continuous Improvement (QCI), ... Global Clinical Trial Operations (GCTO), and Global Clinical Development (GCD)...support and lead global projects in relation to: QUALITY & COMPLIANCE ACROSS GLOBAL CLINICAL DEVELOPMENT:… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … trials from the clinical science perspective, and ensure the writing of high quality clinical trial protocols, review of clinical data and Clinical ... Team (GPT), the incumbent closely collaborates with the Global Clinical Lead (GCL), the Global Team Leader...in one or several programs.- Partner and collaborate with Clinical Operations , Biostatistics and Data Management, Regulatory… 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
- 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
- Merck & Co. (Rahway, NJ)
- …planning and execution of one or more clinical trials. You will assist the Lead Clinical Scientist and study team with the scientific conduct of clinical ... join us-and start making your impact today. -Overview: Global Clinical Trail Operations (GCTO) is a global...training and operational project assignments under the direction of Lead Clinical Scientist and Lead … 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
- Merck & Co. (North Wales, PA)
- …required in the pharmaceutical industry with the majority of time spent in clinical operations .- Proven ability to analyze, integrate, recommend, contribute to ... Job DescriptionPosition Description: Director, Global Clinical Trial Operations (GCTO) Project Management...across initiatives. The incumbent will be expected to directly lead strategic efforts and/or provide input into improvements to… 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)
- …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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. SummaryThis new role is within R&D reporting into Global Clinical Operations (GCO) and the fundamental responsibility is dedicated to GCO. ... of 7 years of experience required Experience Qualifications.7 or More Years 7 years clinical operations experience in trial diversity and patient access and/or … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is expected. The CS Group Lead will also ensure the writing of high- quality clinical trial protocols, review of clinical data and Clinical ... and people with disabilities. SummaryThis position will be the Clinical Science Group Lead in late phase... Clinical Development, Asset & Portfolio Management, Global Clinical Operations , BDM and DLT members. He/she… 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
- Merck & Co. (Rahway, NJ)
- …design and monitoring of clinical programs and studies, producing high- quality clinical documents and presentations.Collaborate with functional area leaders ... Job DescriptionAs a key member of the General Medicine Global Clinical Development team, the Vice President/ Therapeutic Area (TA) Head's primary objectives will be… more
- BioAgilytix (San Diego, CA)
- …support; escalate issues and advise solutions as necessary.Centralize, streamline, and boost clinical kit processes so that lead times, redundancy, and margin ... you enable life-changing, life-saving therapeutics to the patients who need them.The Clinical Kit Coordinator is responsible for supporting the Clinical Kit… 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
- Merck & Co. (North Wales, PA)
- …with squad members including but not limited to scrum masters, technical lead (s) and development team to manage high- quality product delivery leveraging ... accurate data collected from patients who are part of Clinical Trials. Trial Standards, Trial Design, Trial Data Collections,...your employment may pose an undue burden to business operations , in which case you may not be offered… more
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