- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …complete and accurate for assigned stud(ies).If assigned, Associate Director, Clinical Operations may act as the Study Team Leader for the assigned ... disorders.SummaryThe incumbent will be responsible for ensuring execution of clinical studies across geographic regions, in adherence... trial performance and quality metrics and share with study team, Operations Program Lead, and Sr.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good ... and execution of clinical studies...study budgetsCollect information and coordinate with DS Regulatory Operations to post trial information on required public forums… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders.Summary The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions in the West, ... the timeline, budget and objectives set forth by the Study team.The Clinical Study Manager... Study Manager role is primarily a tactical study delivery role, reporting into an Associate … 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 adherence to ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director, Clinical Project & Planning Management is a member ... of the Clinical Business Operations team within Development ...of project management and planning, including related systems/tools, timelines, study metrics, dashboards/analytics, and Key Performance Indicators (KPIs). This… more
- Merck & Co. (Rahway, NJ)
- …Respiratory projects, including pipeline candidates and licensed productsSupervises development of clinical documents including protocols, clinical study ... Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical...your employment may pose an undue burden to business operations , in which case you may not be offered… 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 ... plus. required Experience QualificationsStrong experience and expertise in end-to-end clinical operations functional understanding and execution, including… more
- Novo Nordisk Inc. (WA)
- …North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...NACD & Novo Nordisk (eg, across NACD, CMR, International Operations (IO), and HQ R&D). Provides excellent customer service… more
- Aequor (Thousand Oaks, CA)
- …include: ? Translate Toxicology, Pharmacokinetics and Drug Metabolism (PKDM) and Clinical Development study requirements into an actionable supply plan. ... candidates who are local to sit to support site operations once a week to once a month depending...and budget projections ? Determine distribution strategies for global studies . ? Articulate clinical supply chain management… more
- Aequor (Thousand Oaks, CA)
- …LIMS (laboratory information management system) and a basic understanding of clinical trials understanding, and a strong understanding of MS Excel.This role ... will assist the biospecimen operations team on the day-to-day monitoring and management of...matrixed organization Working knowledge of document management applications and study planning tools (eg. Planisware, SmartSheet, Tableau, Veeva platform,… more
- Merck & Co. (Rahway, NJ)
- …support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in internal and joint ... and supervise the activities of Clinical Scientists in the execution of clinical studies . Work closely with a cross-functional group of experts in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …KPIs, KRIs, KQIs across all RD LFs. Define Cycle Times, Identity key milestones at Study , Country, and Site Level to gauge clinical trial performance. Build and ... roles. Candidate will be responsible for managing external Benchmarking Study Submissions and seeking out external competitive intelligence to.../ GCO / BDM / RD Finance/ CSPV/ Regulatory Operations / QA to ensure optimal definition and adoption… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionBiologics Process R&D Associate ScientistOur Research Scientists are our Inventors.- Using innovative thinking, state-of-the-art facilities, and ... To achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing while providing… more
- Insmed Incorporated (Bridgewater, NJ)
- …related issues.Collaborate with multiple internal and external stakeholders (therapeutic areas, clinical pharmacology, clinical operations , non- clinical ... organizations etc.) to build and to execute the bioanalytical strategy specific to clinical development programs.Participate in clinical study design and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.Provides support ... indications.Support as medical lead for select company-sponsored GMA evidence generating studies /projects. Manages all medical aspects such as study document… more
- Merck & Co. (North Wales, PA)
- …as well as statistical support for translational oncology projects and studies .-Interact with Clinical , Regulatory, Statistical Programming, Data Management, and ... statistical planning and data analysis of Phase I/II oncology clinical trials as well as translational biomarker analyses. This...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Merck & Co. (Rahway, NJ)
- …and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications ... and Pharmacometrics - Immune/Oncology team in the role of Associate Director. The team is part of the Global... Director. The team is part of the Global Clinical Development organization and has oversight over drug development… more
- Aequor (Thousand Oaks, CA)
- …support to the Product Quality (PQ) organization as a subject matter expert of clinical and commercial product stability studies and GMP data management. In this ... or Manufacturing experience, OR Bachelor's degree & 5 years of Quality, Operations , Scientific, or Manufacturing experience OR Associate 's degree and 10… more
- Merck & Co. (North Wales, PA)
- …support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipating in internal and joint ... to post-licensure). The Director will manage the entire cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory… more
- Merck & Co. (Rahway, NJ)
- …simultaneously. Review and provide final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Confidential Investigator Brochures before ... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Primary activities include, but… more
