- Catalent (New York, NY)
- …health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion ... as assigned.The Candidate Proven, successful track record as sales executive or brand manager in a leading company operating in the cosmetic industry, minimum 3… more
- Merck & Co. (Rahway, NJ)
- …GDO focuses on data collection, data review and integrity throughout the lifecycle of clinical trials .- Clinical trials provide the required data which ... a diverse, cross-functional team of individuals who execute our clinical trials . The Fellowship will include progressive...tools critical to the oversight and conduct of a clinical trial - Participate in team meetings to… more
- Merck & Co. (Rahway, NJ)
- …range of stakeholders including the Global Project Manager , Alliance Manager , Global Trial Manager , Clinical Sub Team, Clinical Trial Team, ... Job DescriptionPosition Description: Senior Specialist, Oncology Clinical Development Finance Under the guidance of the Oncology Clinical Development Finance… more
- Merck & Co. (Rahway, NJ)
- …ideas and innovative solutions that enable new capabilities and drive efficiencies in our clinical trials .For this position, Trial Site Monitoring is seeking ... Job DescriptionClinical Operations in our Company Research Labs IT supports clinical trial operations, execution, and management. Our IT team operates as a… more
- Merck & Co. (Rahway, NJ)
- …Department of the GCTO organization focuses on the planning, execution and close out of clinical trials within a program.- Clinical trials provide the ... the scientific planning and execution of one or more clinical trials . You will assist the Lead...tools critical to the oversight and conduct of a clinical trial . Participate in team meetings to… more
- Merck & Co. (Rahway, NJ)
- …DescriptionPosition Description: This role will be key to ensure strong monitoring in our clinical trials . Under the oversight of the Clinical Research ... CRM.Attend local Investigator Meetings if requested to.Interface with GCTO partners on clinical trial execution.Escalates site performance issues to CRM and … more
- Merck & Co. (Rahway, NJ)
- … clinical supply chain across the full company Research Laboratories portfolio of clinical trials . GCS supports more than 300 Phase I-IV clinical ... run by partners, and 300+ company Investigator Initiated Studies (IIS) clinical trials . GCS is accountable for the planning, sourcing, labeling, packaging, and… more
- Merck & Co. (Rahway, NJ)
- …Department of the GCTO organization focuses on the planning, execution and close out of clinical trials within a program.- Clinical trials provide the ... the operational planning and execution of one or more clinical trials . You will have the opportunity...stakeholders (eg, study team, vendors, committees) in support of clinical trial objectives. You will be part… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational ... 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …if scenarios and modelling for increased transparency on impact to clinical trial operational designs, timelines, and operational costs.Identify opportunities ... (eg study start up, protocol development) to ensure Global Clinical Operations (GCO) goals are met.Responsibilities:Execute on end-to-end operational feasibility… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key… 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 ... centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness...of 3-5 years' experience in pharmaceutical or biotechnology in clinical trial operations or clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …data management expertise to project/study teams to optimize study-specific clinical trial processes.May participate in process improvement ... and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical trial outsourcing, health sciences or related field ( clinical trials ) required.Advanced WORD and Excel skills preferred.Excellent time management ... the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional...skills preferred.Experience with PH.1 - PH. IV clinical trial vendor contracts required.Experience with CRO… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …support training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested ... proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with a masters degree required- 3+ Years… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expertise and trending to shape the future of Daiichi Sankyo clinical trials .Responsibilities- Process Improvement, Innovation and Optimization (IO):-Project ... the build of industry expertise in innovation and optimization for clinical trials .-Utilize strategic conferences for information mining and networking,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for investigator-sponsored studies (ISS) and ... clinical trials and with other MA tools (expertise in clinical trial methodology and conduct, GCP principles, medical product support activities,… 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 ... around rare diseases and immune disorders.Summary The Associate Director, Global Clinical Operations (GCO) Procedural Ownership and Life Cycle Management, will be… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …oncology, with a deep understanding of the drug discovery and development process, clinical trials , and regulatory requirements. TravelAbility to travel up to 5% ... areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing,… more
