- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and updates Study Supply Plans in close communication with CSO project Management LeadResponsible for the Clinical Label Development process ... relevant Trial Master Files (TMF) with CSO-related documentsSupports the CSO Project Mgmt Lead in executing additional operational and logistical duties as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …operational planning and execution of FIH, clin pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible for clinical ... execution of all operational components of a large-scale global clinical program using strong clinical project...the overall development plan agreed to by the Global Project Team (GPT). Lead site selection and site… 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 ... and continuously monitored for effectiveness, efficiencies, and areas of improvement.Responsibilities: Clinical Trial Operational Risk (CTOR) Management:Build and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Action/Preventive Action (CAPA) plans and related effectiveness measures, as appropriate.Responsibilities: Clinical Trial Operational Risk Management:Own, lead ... rare diseases and immune disorders. Summary The AD, Global Clinical Operations (GCO) Clinical Trial ...Management Plans (RMPs) (design, management, and maintenance) for global clinical trials .Provide day-to-day support to study teams… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …build 'inspection readiness', identify and mitigate clinical quality risk with the clinical trial teams during study start up, conduct and close out/study ... around rare diseases and immune disorders. Summary The Manager, Clinical Quality Management (CQM), Inspection Readiness Lead ...of 3-5 years' experience in pharmaceutical or biotechnology in clinical trial operations or clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …DS standards. The Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO, 3rd Party Vendor Management and Oversight: ... and interdependencies for assigned clinical study (-ies) utilizing Microsoft Project or equivalent. Lead the creation of the cross-functional Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …path activities and interdependencies for assigned clinical stud(ies) utilizing Microsoft Project or equivalent. Lead the creation of the cross functional ... inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are… more
- Merck & Co. (North Wales, PA)
- …execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on a clinical trial team.Leading medical monitoring team ... Summary: This position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Development in Project Teams, possibly as Global Clinical Lead . ResponsibilitiesStudy Strategy: Clinical study leader (CSL) or major ... Phase 2 studies: Provides input on major milestones of trial , clinical trial plan and...clinical data(eg; Go/No Go decisions, reprioritization, etc.); Operational Project Team (OPT) leader ; Responsible before the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for clinical label development support for all Daiichi-Sankyo led clinical trials requiring Clinical Trial Material (CTM) and will also serve as ... experience related experience, including IT/system management in Pharmaceutical Development / Clinical research, and Project Management required- 1+ years of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader (ITL-ISTL)ResponsibilitiesStudy Strategy: ... if applicable; Defines study strategy across clinical trials within an indication or project ; Attends...meeting and represents clinical /TMCPStudy Planning and Execution: Clinical Study Lead (CSL) for large Phase… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities ... and the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's… 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 ... and continuous improvement, including implementation of training programs (eg, Project Management, laboratory, ).Collaborate with and manages relationships with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project , and quality ... disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in...activities and expectations. Ensure regular updates provided to Study Lead on trial metrics, data, and quality.Establish… more
- Merck & Co. (North Wales, PA)
- …planning, feasibility, and execution of a clinical trial .May serve as the clinical trial team leadMay lead team in key study planning, development, ... Summary: This position leads the operational planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pipeline.Proactively identify Data Standards gaps and resolve issues related to clinical data standards development throughout the trial lifecycle.Standardize ... improvement opportunities.Communicate and reinforce content and interpretation of Daiichi Sankyo's Clinical Data Standards to DS Project and Study teams,… more
- Merck & Co. (North Wales, PA)
- …to these analyses.Prepares oral and written reports to effectively communicate results of clinical trials to the project team, our company's Management, ... Management, and our company's Research Laboratories Scientists in designing and analyzing clinical trials , and in coordinating the statistical activities for … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …execution requiredStrong experience in procedural writing and life cycle management requiredAdditional clinical trial process experience in one or more key ... functional areas (eg clinical research & development, clinical science, clinical quality assurance, project management) preferredStrong leadership,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the clinical study team are in accordance with DS standards. Act as the project manager of the clinical study team to liaise and coordinate with internal ... 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… more
- Insmed Incorporated (Bridgewater, NJ)
- …representative responsibilities will include, but not necessarily be limited to, the following: Lead complex clinical trials or indication corresponding to ... Associate Director of Biostatistics is responsible for the statistical aspects for complex clinical trial (s) or indication product line. This role leads the… more
