- 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 ... 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)
- …provide input into individual career development plan.Assist in planning and execution of clinical studies , under the close supervision of a Manager (or above) ... to the TMFConfirm Essential Document Listing accuracy throughout duration of trialProvide clinical administrative support to the study teams. This may include… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This position ... and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and the Clinical... protocols to ensure consistency in safety requirements across studies related to a similar compound. Develops and maintains… 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, ... interactions with CROs and other external vendors to ensure studies are conducted according to the timeline, budget and...the timeline, budget and objectives set forth by the Study team.The Clinical Study Manager… 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 ... goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile the TMF document… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Associates (SAs) or Senior SAs who assist in planning and in the execution of clinical studies in adherence to the protocol, Good Clinical Practices (GCPs), ... and provide this feedback through regularly scheduled 1:1 meetingsCollaborate with Clinical Study Manager on SA deliverablesParticipates in departmental and… more
- Merck & Co. (Rahway, NJ)
- …operational responsibilities for a single study or across multiple studies (eg, operational deliverables, clinical & ancillary supplies planning/tracking, ... the execution of the Merck clinical research portfolio. The Clinical Sciences & Study Management Department of the GCTO organization focuses on the planning,… more
- Merck & Co. (North Wales, PA)
- …operational responsibilities for a single study or across multiple studies (eg, operational deliverables, clinical & ancillary supplies planning/tracking, ... expertise with team members.May interact with internal and external stakeholders (eg, study team, vendors, committees) in support of clinical trial… more
- Merck & Co. (North Wales, PA)
- …in a clinical trial environment.Required Experience and Skills: Experience with study data standards CDISC Study Data Tabulation Model (SDTM)Experience in ... Job DescriptionThe Senior Statistical Programmer, Study Data Tabulation Model (SDTM), provides oversight and creation of the Study Data Tabulation Mode (SDTM)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead. ResponsibilitiesStudy Strategy: Clinical study leader (CSL) ... studies : Provides input on major milestones of trial, clinical trial plan and contingency planning, Analyzes, updates management...updates; Responsible for valid clinical interpretation of study results as Clinical Study … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and ensure the writing of high quality clinical trial protocols, review of clinical data and Clinical Study Reports (CSRs)/outputs throughout the project ... scientific engagement, and HA responses. Interactions with the internal clinical study physicians and physician scientists as...(Oncology) Clinical Science Strategy and delivery of clinical studies for one or several oncology… 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)
- …integrity, site scientific engagement, and HA responses. Interactions with the internal clinical study physicians and physician scientists as well as external ... of high-quality clinical trial protocols, review of clinical data and Clinical Study ...Global Clinical Science Strategy and delivery of clinical studies in late stage development. Lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … trials within an indication or project; Attends EOP2 meeting and represents clinical /TMCPStudy Planning and Execution: Clinical Study Lead (CSL) for ... study results; Present results to regulatory agencies during pre-submission meetings; Interpret study results in context of other studies in the project and… 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 ... Summary This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Phase 1 (specifically Clinical Pharmacology) studies , support Phase 2/3 studies , represent function on study and project teams, and participate in and ... PK-PD and Pop PK-PD concepts and analysis, phase 1-4 clinical studies , literature, regulatory guidelines, and physiological/pharmacological...as Study Team Leader for Phase 1 Clinical Pharmacology studies , and provides clinical… more
- Merck & Co. (Rahway, NJ)
- …Lead Clinical Scientist and study team with the scientific conduct of clinical studies . In this position, you will have the opportunity to develop your ... for specific clinical /scientific activities on a single study or across multiple studies (eg, medical...stakeholders (eg, country operations, committees, vendors) in support of clinical study objectives. - Support development of… more
- Merck & Co. (North Wales, PA)
- …support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in internal and joint ... may: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)
- …(SME) for inspectors and/or auditors with regards to diversity and inclusion in our clinical studies - Contributes to HA response / leads CAPA activities related ... the data acquisition that study teams will utilize to develop study specific clinical trial diversity plans Leads the strategy of country and site selection… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies , conduct hands on population PK and PKPD analyses and ... documentsServes as a specialist in PK-PD and Pop PK-PD concepts, phase 1-4 clinical studies , literature, and regulatory guidelines and can conduct/develop PK-PD… more
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