- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …accountability for operational study-level timeline, cost, and quality deliverables.Lead the development of the clinical study plan including critical path ... file is complete and accurate for assigned stud(ies).If assigned, Associate Director, Clinical Operations may act as...and delivery of study team plan and milestones (eg protocol , eCRF/EDC, IXRS, Clinical Study Oversight Plan… more
- Merck & Co. (North Wales, PA)
- …lead/support clinical trial scientific-activities.Job ResponsibilitiesResponsible for the clinical /scientific execution of clinical protocol (s).Serves as ... database set up)Lead medical monitoring team in review and interpretation of clinical data/medical protocol -deviations in collaboration with the Clinical … more
- Novo Nordisk Inc. (Los Angeles, CA)
- …site management activities. Takes ownership to deliver upon near-term North America Clinical Development (NACD) goals, including successful delivery of studies ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...Ensure accuracy, validity and completeness of data collected at clinical trial sites in accordance with the protocol… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...with internal experts and external KOLs, Ad Boards for protocol development ; Provides input on CRO /… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …& process compliance. Takes ownership to deliver upon near-term North America Clinical Development (NACD) goals, including successful delivery of studies within ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including critical path activities ... primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy....and delivery of study team plan and milestones (eg protocol , eCRF/EDC, IXRS, Clinical Study Oversight Plan… more
- Merck & Co. (Rahway, NJ)
- …role will work across the different country operations roles (eg CRM( Clinical Research Manager), CRA( Clinical Research Associate )-Manager,-Partners, TA-Head, ... role is accountable for execution and oversight of local operational clinical trial activities-in compliance with ICH/GCP and country regulations, company policies… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...This includes leading processes and technology improvements to link Clinical trial site needs, Finance and Supply forecasts that… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diverse external providers for clinical trials, companion diagnostics trials, clinical development , and regulatory submissions. This position may propose ... to study teams in preparation for upcoming audits. Complies with the protocol , Policies, SOPs, external/internal standards, pertinent Good Clinical Practices… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …activities assigned, eg for a clinical study: provide input on the development of study protocol (design, sample size, statistical analysis strategy); Review ... Qualifications- At least 5 years of experience as statistician supporting drug development and/or post marketing in Clinical research, Pharmaceutical company,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in data science / business intelligence / statistics role supporting drug development and/or post marketing in clinical research, pharmaceutical, CRO or ... end-to-end delivery of AI/ML projects (from business understanding, over hands-on development to dissemination), to ensure high quality deliverables are on time… more
- Aequor (Thousand Oaks, CA)
- … development teams, providing hands-on formulation and process expertise during the development of clinical and commercial formulations for solid oral dosage ... for an enthusiastic, highly motivated, and team-oriented scientist for the position of Associate . In this role, the scientist will serve as member of Drug Product… more
- Insmed Incorporated (Bridgewater, NJ)
- …strategy specific to clinical development programs.Participate in clinical study design and documentation (lab manual, protocol , report, SAP)Participate ... for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development , the role focuses on LC-MS/MS of small… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within ... of clinical trials is required Demonstrates technical expertise within Clinical Development , Medical Affairs, and Regulatory Affairs (CMR), staying… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position works under some supervision to solve complex study problems.Responsibilities- Protocol Development , Case Report Form (CRF; review), Statistical ... report (CSR): Leads statistical activities for complex studies including study design, protocol development , CRF review, SAP development , analysis files… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CRO and other third party vendors to ensure compliance with the protocol , external/internal standards, Good Clinical Practices (GCPs), applicable regulatory ... high quality deliverables on time and within budget to support drug development processes and global submissions. This position provides leadership within Data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol , Good Clinical Practices ... college or university)Bachelor's Degree (preferred in Life Sciences) with relevant clinical development experience required Experience Qualifications1 or More… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within ... is preferred A minimum of eight (8) years of progressively responsible clinical development /trial experience within a pharmaceutical, biotechnology, or CRO… more
- Insmed Incorporated (Bridgewater, NJ)
- … clinical trial(s) or indication product line. This role leads the protocol statistical section development , study setup, execution, analysis, and reporting ... Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director of Biostatistics is responsible for the statistical aspects for… more
- New Hanover Regional Medical Center (Wilmington, NC)
- …applicable by site: * 1. Safety * Corroborates patient's identification and clinical history with procedure and ensures information is documented and made available ... and anatomical laterality. * Ensures complete examination is performed following protocol . * Ensures timely review and transfer of images and pertinent… more
