- Merck & Co. (Rahway, NJ)
- …improvements in quality, efficiency, and productivity across the organization. Keeps abreast of project management , clinical data standards, and ... clinical data standards, technology, and clinical data management disciplines; actively...project management .2+ years' experience working in clinical development or clinical data … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or more key functions (eg, clinical research, clinical operations, data management , biostatistics, project management ) required- Collaboration, ... and change management skills in a complex, matrix environment including project management preferred- Experience in clinical trial design and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or more key functions (eg, clinical research, clinical operations, data management , biostatistics, project management ) required- Effective ... management skills in a complex, matrix environment including team leadership or project management required- Experience in clinical trial design and… more
- Merck & Co. (North Wales, PA)
- …appropriate by managementEducation Minimum Requirement: Bachelors degree with 1 year of clinical data management or standards experienceOrAssociates degree ... with staff across multiple company sitesMay support any other project or perform any other data ...with 3 years of clinical data management or standards… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Improvement:Provides comprehensive data management expertise to project /study teams to optimize study-specific clinical trial processes.May participate ... management , and risk management . ResponsibilitiesLeadership, Direction, and Strategy:Establishes Data Management strategy at the project and/or study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... strategy; Leads Integrated Project Team (IPT) working closely with Global Project Management to ensure cross-functional coordination and focus to agreed… more
- Merck & Co. (North Wales, PA)
- …data collection in alignment with the protocol in collaboration with Data Management /Programming.Collaborating cross-functionally to monitor clinical ... writing, and presentation skillsEducation/Experience: Bachelor's Degree +5 years of pharmaceutical, clinical drug development, project management , and/or… more
- Novo Nordisk Inc. (San Antonio, TX)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... strategies Implements proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management , Biostatistics, Pharmacology, and other ... , and provide safety leadership including but not limited to clinical studies, post-marketing surveillance, signal detection and management , important… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …assigned clinical studies, through inspection readiness preparation - Project Management : - Coordinates SMT/Product-level safety meetings, maintains roster, ... Summary This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership... Clinical Safety Scientist Lead and PSL or Clinical safety physician(s) to evaluate safety data … more
- Merck & Co. (Rahway, NJ)
- …and clinical outcomes assessments.2. Serves as project manager of all clinical data management activities for trials as assigned.- Under the guidance ... Manager creates and ensures the successful execution of the clinical data management strategy for...senior staff when appropriate, uses excellent interpersonal, negotiating, and project management skills to perform and manage… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …standards, (v) encouraging innovation.Build strong relationships with clinical development, clinical sciences, regulatory, biostats, data management , and ... rare diseases and immune disorders.Summary The Executive Director, Global Clinical Operations Study Management Group Head has...ideally including time in role such as a Global Project Leader at Sr. Director level or equivalent preferred-… more
- Merck & Co. (North Wales, PA)
- …with the protocol.Minimum education required: Bachelor's Degree +2 years of pharmaceutical, clinical drug development, project management , and/or medical ... field experienceOR Master's Degree +1 year of pharmaceutical, clinical drug development, project management , and/or medical field experienceDegree in life… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …setting required.- Experience in Companion Diagnostics preferred.- Completion of Project Management Training or training in Finance/Business is ... patients who are likely to benefit from our therapeutics.Responsibilities:- Leads CDx project teams for the diagnostic, in full alignment with Global Program Teams… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …required.Knowledge of CDISC and SDTM and industry standard data collection practices. Clinical data management experience in a medical device, ... maintains positive relationships with internal/external stakeholders/vendors/partners. Project Management :Provides guidance for collection of all external data… more
- Merck & Co. (Rahway, NJ)
- …within the pharmaceutical or a related industry (hospital, public health, etc.) Strong project management skills and the ability to juggle multiple tasks and ... of clinical trials communications into strategic planning and priorities.Analyze data to enable greater awareness and understanding of how the communications… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and SDTM and industry standard data collection practices preferred- 7+ years Clinical data management experience in a medical device, pharmaceutical ... data management activities by managing external data processes including providing guidance to Project ...7+ years working knowledge of Clinical trial data systems and/or EDC lab management tools… more
- Merck & Co. (North Wales, PA)
- …of- statistical and data processing software eg SAS and/or R.-Good project management skills. --Good understanding of worldwide regulatory requirements and ... and statistical analysis methods fundamental to effective pharmaceutical R&D.- The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …monitoring plans.Accountable for accuracy and timeliness of information in all data management activities, databases and tracking systems.Company Sponsored ... operations clinical trial activities, ensuring adherence to timelines, budgets, project , and quality plans, and relevant ICH/GCP Guidelines Review protocols to… more
