- 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
- 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)
- …to applicable Daiichi Sankyo and regulatory requirements. Functional Expertise:Reviews/approves clinical study related documents (eg, Protocols, Data Management ... and Strategy:Establishes Data Management strategy at the project and/or study level for a smaller number of projects/ studies...Plan, Clinical Study Reports).Leads and drives the data review process in… 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
- 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).Responsibilities- Reconcile the… 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
- Merck & Co. (Rahway, NJ)
- …site contact and site manager throughout all phases of a clinical research study ,-taking overall responsibility of allocated sites.Actively develops and ... ensures continuity of site relationships through all-phases of the trial.Performs clinical study site management/monitoring activities in compliance with… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality culture within Global Medical Affairs Quality Assurance by providing study team support to uphold the ethical conduct of interventional, non-interventional, ... Business Unit Strategy globally; promote a quality culture by providing study team support to uphold the ethical conduct of interventional, non-interventional,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …TLFs generated by statistical vendor, ensure deliverable quality for the pivotal studies , Integrated Summary of Efficacy (ISE)/Integrated Summary of Safety (ISS) for ... submissions. Responsibilities include: review Case Report Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... to support drug development processes and global submissions as required for clinical trials. These include developing and validating SAS programs for clinical… 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 complex ... disabilities.SummaryThis position supports early phase oncology development and leads complex studies in study design, statistical analysis and interpretation of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …contracts. Performs financial reconciliation and negotiation of Vendor contracts prior to study termination and contract closure. Manages all aspects of sourcing and ... to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services...the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... cleansing and standardizing data, with a focus on eg, clinical , product, and vendor data and Identify and rectify...and Investigators - Safety-Reporting Requirements for INDs and BA/BE Studies (December 2012) o Japan Ministry of Health, Labor… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and support the PRA strategies and tactics of additional indications. With manager oversight, the individual will lead global pricing strategy development, access ... functions including but not limited to Commercial, Marketing, Medical, Clinical Development, Public & Government Affairs.Responsibilities- Lead the development of… more
- Stryker (Mahwah, NJ)
- …precision. **What you will do** As the ** Clinical Study Manager (CSM),** you will manage ongoing Investigator-Initiated Studies and/or Stryker Initiated ... by visiting stryker.com Stryker is seeking to hire a ** Clinical Study Manager ** to support...research strategy. + Develop and maintain overall dashboard of clinical and non- clinical studies , including… more
- Merck (Rahway, NJ)
- …event reporting requirements internally and externally. The CRM ( Clinical Research Manager ) could be responsible for a particular study for several countries ... and escalates performance issues and training needs to CRA ( Clinical Research Associate) manager and/or functional vendor...and executing a local risk management plan for assigned studies . + Ensures compliance with CTMS Clinical … more
- International Rescue Committee (New York, NY)
- Requisition ID: req45075 Job Title: Clinical Program Manager , Home Study and Post-Release Services Sector: Social Work Employment Category: Fixed Term ... HQ USA Work Arrangement:Hybrid Job Description SCOPE OF WORK: The IRC's Home Study and Post-Release Services (HSPRS) for unaccompanied children in the US is growing… more
- Danaher Corporation (New York, NY)
- …critical role in the timely, effective, and quality completion of a cardiac enrollment clinical study . This position is responsible for systematic and organized ... Clinical Affairs team and report to the Senior Manager Clinical Affairs who is responsible for...management and data review of a new cardiac enrollment study , which involves active mentoring, regular coaching, and developing… more
