- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …; Identify issues and propose solutions. Proactively assess potential risks to the study and propose mitigation plans. Monitor study budget against progress ... be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions in the...budget at a task level. Specifically track short-term operational study timelines and monitor operational performance metrics… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the ... to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile the TMF document trackers generated by the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … study conduct, close out and reporting.Proactively assess potential risks to the study and propose mitigation plans. Monitor study budget against trial ... be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence...identification activities in collaboration with the CRO and the study team. Oversee the site qualification process. Monitor … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clin pharm patient studies , and Phases 1-3 clinical trials at the study and program level. Responsible for clinical program planning and execution (from study ... an overall study level. Specifically, track major study milestones and monitor overall operational performance...Governance Committee. Analyze CRO performance trends within a clinical study or across several studies and resolve… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …committee setup; Interacts with KOLs and PIs to plan study and monitor completionStudy outputs: For Phase 2 studies : Drafts responses to IRBs and ... for valid clinical interpretation of study results as Clinical Study Leader, medical monitor or regional clinical/Translational Medicine and Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of high quality clinical trial protocols, review of clinical data and Clinical Study Reports (CSRs)/outputs throughout the project life cycle. The CS lead will also ... contribute to the program study strategy, planning, execution and reporting outputs. CS lead...Global (Oncology) Clinical Science Strategy and delivery of clinical studies for one or several oncology assets:- Lead and… more
- Merck & Co. (North Wales, PA)
- …execution of one or more clinical trials. Assists the Lead Clinical Scientist and study team with thescientific conduct of clinical studies . In this position, ... cross-functional team.Job ResponsibilitiesResponsible for specific clinical/scientific activities on a single study or across multi e studies (eg, medical… more
- Merck & Co. (Rahway, NJ)
- …Clinical Scientist and study team with the scientific conduct of clinical studies . In this position, you will have the opportunity to develop your leadership, ... the following: - Responsible for specific clinical/scientific activities on a single study or across multiple studies (eg, medical monitoring, lab specimen… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with appropriate training and experience or arrange requisite support to lead large study teams, coordinate complex studies , lead projects, and/or ensure proper ... our Discovery and Research programs for development of early clinical studies . Provides senior level clinical representation at meetings with health authorities;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …site scientific engagement, and HA responsesInteractions with the internal clinical study physicians and physician scientists as well as external investigators is ... of high-quality clinical trial protocols, review of clinical data and Clinical Study Reports (CSRs)/outputs throughout the project life cycle is optimized across… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …site level activities through targeted risk-based site contacts and on-site visits to monitor study sites protocol execution and compliance to applicable DS SOPS ... 4) people manage in future. Responsible for the successful delivery of study diversity plans in adherence with Good Clinical Practices (GCPs), appropriate Standard… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … study conduct, close out and reporting.Proactively assess potential risks to the study and propose mitigation plans. Monitor study budget against trial ... and site identification activities in collaboration with the CRO and the study team. Oversee the site qualification process. Monitor clinical trial performance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trial diversity strategy and tactics as appropriate Leads the data acquisition that study teams will utilize to develop study specific clinical trial diversity ... Matrix management responsibilities across the internal and external network Supports study teams by implementing the DS framework, guidance and further instruction… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the internal and external network Manages Phase 1 - Phase 3 studies (depending on assignment) with demonstrated decision-making capabilities Provides medical and ... scientific expertise to cross-functional DSI colleaguesResponsibilitiesMedical Monitoring- For studies in which Medical Monitoring activities are conducted in-house:-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Summary Responsible for end-to-end operational feasibility deliverables at the disease, program, study , country, and site levels. This position is required to work ... may directly or indirectly support Feasibility and/or additional related areas (eg study start up, protocol development) to ensure Global Clinical Operations (GCO)… more
- Tris Pharma (Monmouth Junction, NJ)
- …execution to formulate medical understanding of safety and efficacy resultsActs as Medical Monitor for one or more studies , as neededCollaborates with assigned ... and company clinical programs. ESSENTIAL FUNCTIONS Responsible for generation of key study documents and medical oversight of clinical study conduct;… more
- Catalent (Philadelphia, PA)
- …configured to hold a single product or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and ... and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and...reading of written documents and frequent use of computer monitor . Why you should join Catalent: Defined career path… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to help track and oversee the progress of clinical trial risks at both a study and aggregate level to monitor and evaluate risks/issues across GCO and ... operational risks and other day-to-day CTOR activities to support study teams.As needed, involved in due diligence activities during...effectiveness of initiative and/or process implementation. Monitor key risk metrics and partner with SMEs to… more
- Aequor (Athens, GA)
- …this individual assists with scientific procedures in accordance with study protocols, completes and maintains appropriate documentation associated with all ... and maintains records of animal care, preventive medicine, USDA-required, and study protocol-driven documents. Provides animal husbandry and care including provision… more
- Insmed Incorporated (Bridgewater, NJ)
- …preferred. Minimum of 15 years of experience as a regulatory toxicologist ( study director/ monitor and/or project lead) in the pharmaceutical or biotechnology ... nonclinical safety data package, oversee safety pharmacology and toxicology studies , author nonclinical sections in regulatory submission documents, and address… more
