- Daiichi Sankyo, Inc. (Bernards, NJ)
- Senior , Clinical Study Associate Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of ... key study documents to the CRO and vendors as appropriate.Provide clinical administrative support to the study teams. This may include preparing… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire...safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in… more
- Merck & Co. (Rahway, NJ)
- …of clinical biomarker specimen collection, testing and data delivery activities in clinical studies . The primary focus of this position is in oncology, ... forwardParticipate as a co-author for drafting relevant biomarker sections of clinical study protocolWork closely with Translational Molecular Biomarker (TMB)… more
- Merck & Co. (Rahway, NJ)
- …Respiratory projects, including pipeline candidates and licensed productsSupervises development of clinical documents including protocols, clinical study ... Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical...development of assets within the Respiratory Section of Global Clinical DevelopmentMay serve as a senior therapeutic… more
- Merck & Co. (Rahway, NJ)
- …simultaneouslyReview and provide final approval of Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures before release ... Job DescriptionWe are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs...single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. Key Functions… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) Study Planning and Execution: Provides ... Budget; Establishes effective communication between CRO / vendors / AROAdditional non- study related activities: Occasional senior management interactions at… more
- Merck & Co. (Rahway, NJ)
- …simultaneously. Reviews and provide final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Confidential Investigator Brochures ... labeling and obtain shortest time to approval by global regulatory agencies.Reports to Associate Vice President, Executive Director, or Senior Director in the… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …position, task oriented in the execution of processes, as directed by senior staff, playing a supportive role in ensuring adherence to Project objectives, ... vendors. Supports regular vendor/sponsor discussions to identify risks and ongoing study support. Identifies critical issues which may compromise patient dosing or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and control of Clinical Project Budget in support of Phase I-III clinical studies . Partner with Project Management, Clinical Operations and other ... Effectively uses and communicates key findings and presents recommendations to Senior Regional and Global Finance Leaders.- Annual Portfolio Prioritization -… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for aligned therapeutic / franchise area(s). Relationships Reports to the Senior Director of Value Communication and Contracting Strategy. Interacts frequently in ... collaboration with internal management and senior level managed markets customer representatives. Interacts internally with team representatives from PCOR & Finance,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of all clinical and nonclinical documents for submissions, eg, clinical protocols and study reports, preclinical reports, investigator brochures, application ... MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- ** Senior , Clinical Study Associate ** **Join a Legacy of Innovation 125 Years and Counting!** Daiichi Sankyo Group is dedicated to the creation and supply ... to the CRO and vendors as appropriate. + Provide clinical administrative support to the study teams....+ Provide clinical administrative support to the study teams. This may include preparing meeting logistics, distributing… more
- IQVIA (Parsippany, NJ)
- …other required study documentation. * Act as a mentor for clinical staff including conducting co-monitoring and training visits. * Collaborate and liaise with ... Overview Perform monitoring and site management work to ensure that sites are conducting the study (ies) and reporting study data as required by the study … more
- WuXi AppTec (Cranbury, NJ)
- **Overview** The Clinical Research Associate III Senior Oncology performs and coordinates aspects of field-based and office-based monitoring and data quality ... **Essential Job Functions:** + Responsible for all aspects of clinical monitoring and required reporting, including pre- study ...or supervisor, including but not limited to mentoring of Clinical Research Associate (CRA) I and II… more
- New York University (New York, NY)
- …NYU School of Professional Studies seeks an Assistant Dean and Clinical Assistant/ Associate Professor for the Division of Applied Undergraduate Studies ... Management, Technology, Social Sciences, Liberal Arts and Humanities. Reporting to the Associate Dean of DAUS, the Assistant Dean provides day-to-day oversight of… more
- Actalent (New York, NY)
- Job Title: Senior Clinical Study ManagerJob...be responsible for ensuring the delivery and execution of clinical studies in one or more geographic ... troubleshoot routine inquiries. The position is primarily a tactical study delivery role, reporting to an Associate ...execution. Key responsibilities include leading the development of the clinical study plan, managing study … more
- Merck (Rahway, NJ)
- **Job Description** The ** Senior Clinical Director (Sr. Principal Scientist)** has primary responsibility for the strategic planning and directing clinical ... in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire...safety and efficacy as well as new drug applications, clinical study reports, or publication; and +… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and ... accountable for ensuring consistency of process and approaches across clinical study results. + Leads all aspects...Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress. +… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …+ Responsible for the relevance and accuracy of medical science underpinning the clinical study , based on thorough scientific review and consultation with ... Strategy Head for the Program + Designs POC-enabling human studies , First-In-Human (FIH) studies , POC ( clinical...the medical and scientific portions of protocol synopsis and clinical study protocols and amendments; Reviews and… more
