- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Job Summary: Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the Study ... (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor performance against project goals and… more
- Merck & Co. (Rahway, NJ)
- …Practice (GLP) studies .The Associate Principal Scientist is the primary clinical study team leader and has overall responsibility for a study .The Associate ... function is to design, coordinate, monitor, and report clinical laboratory and field studies that will support the regulatory approval of new companion animal and… more
- Daiichi Sankyo, Inc. (Bernards, 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 ... Governance Committee. Analyze CRO performance trends within a clinical study or across several studies and resolve...within a clinical study or across several studies and resolve or escalate accordingly. People and Resource… more
- Merck & Co. (Rahway, NJ)
- …GCP, local and global policies and procedures to conduct high-quality, inspection ready studies is essential. The position is accountable for trial quality and audit ... company which will be dependent on country/cluster and the study type and stage.ED is the primary country/ cluster...clinical trial execution in all its aspects across all studies & phases in scope of GCTO within the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Job Summary: Position leads complex studies in study design, statistical analysis and interpretation of results ... and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …programming, reporting, and external data acquisition and validation deliverables for all studies consistent with IDRP, study data listings, exception data ... delivery of programming deliverables, including integrated data review plan (IDRP), study data listings and exception reports, sample data reconciliation, external… more
- Eisai, Inc (Nutley, NJ)
- …execution within a pharmaceutical or biotechnology company. This role ensures studies are conducted efficiently, within budget, and in compliance with regulatory ... standards. The Head of Clinical Operations leads teams of study managers and other clinical operations staff while strategically planning and managing multiple… more
- Merck & Co. (South San Francisco, CA)
- …to the following: conduct TK modeling to support dose-selection on toxicity studies , provide TK study design, calculate PK/TK parameters, interpret results, ... quality scientific results according to agreed timeline for several concurrent studies .Effectively communicate study results at internal meetings, as… more
- Merck & Co. (Boston, MA)
- …will manage the entire cycle of late-stage clinical development and studies , including development strategy, study design, initiation, execution, monitoring, ... or marketed Atherosclerosis drugsAnalyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as… more
- Merck & Co. (Rahway, NJ)
- …and programsIn collaboration with internal teams and external partners, designs studies , authors study protocols, develops measurement questionnaires, case ... of this role. This position may have people management responsibility.Types of studies executed include prospective and retrospective observational studies to… more
- Merck & Co. (Rahway, NJ)
- …(LCEs) of an interventional nature and Clinical Research Organization (CRO) run studies . Adherence to Good Clinical Practice (GCP), local and global policies and ... procedures to conduct high-quality, inspection ready studies is essential. The position is responsible for trial...groups within GCTO, especially with Clinical - Sciences and Study Management (CSSM) and regional Quality Managers, to deliver… more
- Merck & Co. (New York, NY)
- …approved, in-development, and active company-sponsored trials and/or investigator-sponsored research studies - The Regional Medical Scientific Director serves as a ... within our AOI to determine the alignment with our research strategies, studies concepts, scientific merit, and qualifications for a specific compound or trial.… more
- Eisai, Inc (Nutley, NJ)
- …the clinical, project management, and data manager teams on strategic designs of studies ; develops, reviews and/or approves study documents such as clinical ... and development tasks. Essential Functions 1. Reviews protocols and other study documents that are developed in collaborations of business alliances. Leads… more
- Eisai, Inc (Nutley, NJ)
- …you. The Clinical Trial Assistant will support all phases of clinical study activities (feasibility, start-up, conduct and close-out) under the direction and ... supervision by study Clinical Operations Lead(s). Plans, support, creates, and communicates...Clinical Operations Lead(s). Plans, support, creates, and communicates clinical study timelines. Gathers input from cross-functional teams and creates… more
- Merck & Co. (North Wales, PA)
- …approved, in-development, and active Company-sponsored trials and/or investigator-sponsored research studies . The Regional Medical Scientific Director serves as a ... within our AOI to determine the alignment with our research strategies, studies concepts, scientific merit, and qualifications for a specific compound or… more
- Aequor (Thousand Oaks, CA)
- …to support inspection readiness for various clinical programs and clinical studies . Key Responsibilities: Inspection Readiness for clinical programs and studies ... - Retrieve documents from external vendors - Create process and clinical study overviews/ storyboards and other inputs for inspection presentations - Organize… more
- Genmab (NJ)
- …and development of data-driven early indication and program assessments, study -level feasibility assessments, robust country and site identification, support of ... and processes to inform risk-benefit decision making at TA, program and study levels.This position reports to our Princeton, NJ office and is… more
- Novo Nordisk Inc. (San Francisco, CA)
- …products and development activities in the medical community Collaborates with trial/ study investigation sites; ensuring effective coordination and facilitation of ... studies to ensure timely review, initiation, and completion, as well as publication of study results. Provides clinical support in cooperation with other Novo… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Eisai, Inc (NJ)
- …users are effectively utilizing the eTMF system for active and archived studies . This includes overseeing the daily global eTMF system related activities relating ... to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness and...following activities:Provide oversight to eTMF system administration activities (ie study set-up, country/site updates, user access, etc.)Triage and assess… more
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