- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …according to the timeline, budget and objectives set forth by the Study team.The Clinical Study Manager role is primarily a tactical study delivery role, ... in accordance with DS standards. Act as the project manager of the clinical study team to...to the CRO, but includes ancillary vendors (eg translations, trial insurance, and central laboratory).Work closely and oversee CRO… 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
- 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
- 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
- Novo Nordisk Inc. (WA)
- …the application of those principles to trial planning and conduct of clinical trials Demonstrates proficiency with computer skills (MS Office, MS Project, MS ... Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex… 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
- 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)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... regulations/EU 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)
- …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
- 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)
- …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
- 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
- Merck & Co. (North Wales, PA)
- …Summary: This position leads the operational planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will ... apply project management, communication, and collaboration skills in-support of our clinical trials . Job Responsibilities: Responsible for the operational… more
- Merck & Co. (Rahway, NJ)
- …This position contributes to the operational planning and execution of one or more clinical trials . In this position, you will have the opportunity to develop ... management, communication, and collaboration skills in support of our clinical trials . - Job Responsibilities May.... , study team, vendors, committees) in support of clinical trial objectives. Core Skills Working knowledge… 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
- Merck & Co. (Irving, TX)
- …The position will require developing trial protocols, monitoring and summarizing clinical and marketing support trials specific to dairy animal health.- ... technical expertise.Assist research and development team with product evaluation, licensing trials and product development for all our company products. Perform… 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)
- …to support drug development processes and global submissions as required for clinical trials . These include developing and validating SAS programs for ... areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is... clinical trials . This position will work closely… more
