- Merck & Co. (Rahway, NJ)
- … Clinical Research, the individual is responsible to-manage/oversee a team of CTCs( Clinical Trial Coordinator).As line manager the role is critical to ... role will work across the different country operations roles (eg CRM( Clinical Research Manager ), CRA( Clinical Research Associate)- Manager… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic...and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is… more
- Arthrex (Naples, FL)
- …, biomaterials and biomechanical professionals. Arthrex is actively searching for an Associate Clinical Study Manager to join the Orthopedic Research ... eTMF design, CTMS design, and user testing for assigned studies Respond to site inquiries for study -related...with protocols, case report forms, and information packets for clinical studies Assist with recruiting and qualifying… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … clinical activities as appropriate.Responsibilities Clinical Operations Study / Program ManagementCompany Sponsored Studies (CSS) Support the preparation, ... the global clinical operations systems for management of company sponsored studies review and approvals are current and accurate.Liaison and reporting on … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …assigned clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and review Statistical Analysis Plans (SAPs) and statistical ... as a project manager for other activities involving assigned product(s) or clinical studies , as needed Qualifications: Successful candidates will be able to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …according to applicable Daiichi Sankyo and regulatory requirements.Functional Expertise:Reviews/approves clinical study related documents (eg, Protocols, Data ... and Strategy:Establishes Data Management strategy at the project and/or study level for a smaller number of projects/ studies...Management Plan, Clinical Study Reports).Leads and drives the data review process in… more
- Merck & Co. (Rahway, NJ)
- …site contact and site manager throughout all phases of a clinical research study , taking responsibility of allocated sites.Develops strong site relationships ... Job DescriptionWith support of Sr CRA/CRA Clinical Research Associate) and/or CRA Manager ,...of site relationships through all phases of the trial.Performs clinical study site management/monitoring activities in compliance… more
- Merck & Co. (Rahway, NJ)
- …primary site contact and site manager -throughout all phases of a clinical research study , taking responsibility of allocated sites.Develops strong site ... Job DescriptionWith support of Sr CRA ( Clinical Research Associate) and/or CRA Manager ,...continuity of site relationships through all-phases of the trial.Performs clinical study site management/monitoring activities in compliance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …sections of submission documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member with ... support to the CSL and Medical Monitor in the execution of Clinical Development functions. Responsibilities Study Strategy: Drafts development plan under… more
- ICONMA (Atlanta, GA)
- …white glove role and able to support IRT users internally and externally. . Clinical Study Management, Supply Chain and Data Management functions) and technology ... of interactive response technology (IRT) solutions to support a clinical trial. The Manager , Clinical .... Lead and facilitate system requirements gathering meetings with clinical study teams and IRT supplier contacts.… more
- Merck & Co. (Rahway, NJ)
- …management duties supporting one or more clinical trials. Under the oversight of a clinical scientist, study manager , or program lead, the Clinical ... and reconciling labs/sam esMay interact with internal and external stakeholders (eg, study sites, committees) in support of clinical trial objectivesCore… more
- Merck & Co. (Rahway, NJ)
- …for a wide range of stakeholders including the Global Project Manager , Alliance Manager , Global Trial Manager , Clinical Sub Team, Clinical Trial ... improve lives. -Position Description: Under the guidance of the Oncology Clinical Development Finance Associate Director, the Finance Senior Specialist will:Provide… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the ... Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ...milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).ResponsibilitiesReconcile the TMF… more
- Aequor (NJ)
- …defining, planning, and communicating clinical supply strategy in support of global clinical studies , as well as monitoring and reacting to unforeseen ... of clinical supplies required to support global clinical research and development studies during phases...Customers and Service Providers, including but not limited to Clinical Research and Development, Global Study Management… more
- Eisai, Inc (Nutley, NJ)
- …led by Translational Science to evaluate biomarkers across programs, as well as the study statistician for clinical studies . As the statistical lead for ... managing CROs. The immediate need is to manage early clinical development studies primarily in support of...conduct to proactively address issues to ensure high quality study data (as needed). Clinical Study … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …establishing data collection, data standards and data cleaning needs for DS Programs / Studies .Serve as the subject matter expert for Study Data Managers during ... of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical...to support the collection of diverse external data types.Advises Study Data Manager on complex vendor management… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …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...leveraging competencies, tools and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium ... and immune disorders. Summary Position leads statistical support for medium complexity studies including contributing to development of optimal study design,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …goals, including those specifically aligned with the planning & successful delivery of studies within the clinical trial portfolio. Relationships Reports to a ... Senior Manager (or above) within North America Clinical Development (NACD). Manages mutually beneficial relationships with external partners relevant to the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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...leveraging competencies, tools, and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships… more
