- Novo Nordisk Inc. (Plainsboro, NJ)
- …focused approach, leveraging competencies, tools and technology. Relationships Reports to a Manager (or above) within North America Clinical Development (NADO). ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Tris Pharma (Monmouth Junction, NJ)
- …portfolio of best-in-class ADHD medicines and an exciting pipeline of clinical -stage programs across Pain, Psychiatry, and Neurology. Our proprietary technologies ... an immediate opening in our Monmouth Junction, NJ facility for a Senior Manager , Business Development.The primary role of the Senior Manager , Business… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …- Collaborates with Clinical Safety Scientist Lead and PSL or Clinical safety physician(s) to evaluate safety data of any source to identify potential ... surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead , Product Safety Lead (PSL), … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …alignment on key activities and expectations. Ensure regular updates provided to Study Lead on trial metrics, data , and quality.Establish strong partnership with ... rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …technologies, thereby developing optimal approaches to support the collection of diverse external data types.Advises Study Data Manager on complex vendor ... data standards is required.Knowledge of CDISC and SDTM and industry standard data collection practices. Clinical data management experience in a medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory ... Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting, and analytics for RA. This will include working within and optimizing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …staff training and development progress and provide assessment feedback to employees and manager (s) as needed Develop and lead internal and external trainings ... callibration of Patient Safety calls as it relates to training progression Lead continuous improvement projects as required Assist Manager (s) with communication… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …teams on various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously. ResponsibilitiesManage ... centered around rare diseases and immune disorders. Summary The Manager , Data Programming is a member of... data review listings and reports to support Data Management and clinical teams.Develop, implement and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Supervise designated personnel. Relationships Report to the Director/Associate Director/ Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for ... role will consist of these components including: Expand and lead our Data Stewardship Working Group (DSWG)...management.- Develop and implement strategies for cleansing and standardizing data , with a focus on eg, clinical ,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …team, we encourage you to apply. Are you ready? The Position To develop and lead an obesity sales team in the execution of sales strategies within obesity accounts, ... utilizing a patient-centric and clinical approach to selling to ensure strong relationships are...items Ensure timely and accurate transmission of OCS call data Monitor and reinforce the use of the Sales… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Order process, bid defense meetings, and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when applicable. Serve as a ... team as an extended part of committee. Advise Study Data Manager on complex vendor management issues...standard data collection practices preferred- 7+ years Clinical data management experience in a medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of National Advisory Board meetings, at the discretion of Executive Director) Deliver clinical data and other presentations at National Advisory Board meetings ... for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead...gain feedback from advisors Support other advisory boards with clinical data and other medical presentations Partner… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …all external information of the program, including publications, regulatory documents, clinical trial registers, data release, etc. Accountable for protecting ... In this key role, the candidate will have to lead a complex, global team in charge of a...a complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help ... addition, this role will support the FxExc Director in lead innovation and optimization by gathering industry expertise and...including experience in one or more key functions (eg, clinical research, clinical operations, data … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data . Work closely with ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ensure high data quality and proactive detection and resolution of issues. Lead effective communications within the GPT, by interacting with other GxP QA ... System [QMS] QA, PV/MA Quality) and in close collaboration with CAPA Manager .), on GxP topics/issues impacting the respective clinical programs.Help to… more
- Merck & Co. (Rahway, NJ)
- …, biomarker data , and clinical outcomes assessments.2. Serves as project manager of all clinical data management activities for trials as assigned.- ... creates and ensures the successful execution of the clinical data management strategy for assigned trials...guidance of more senior staff, may serve as the data management lead or perform a support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …place in accordance with the RSEM and local country teams.Partner with TMF lead and CRO Oversight leaders to ensure CRAs are updating appropriate systems.Ability to ... analyzes data /metrics/key performance indicators to support vendor/CRO oversight of CRAs...performance indicators to support vendor/CRO oversight of CRAs in clinical trials.Provide direction to Alliance and CRO CRA leadership… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .- Drug Development ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies… more
