- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction ... and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is...quality deliverables. Lead the development of the clinical study plan including critical path activities… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Cardiometabolic Our Clinical Research and Pharmacovigilance team push the boundaries of global ... and execution of a clinical protocol.- May lead team in key study planning, development...initiation, interim and close out visitsExperience as a CRA Manager , Lead CRA or Project ManagerRare disease… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …sections of submission documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member with ... support to the CSL and Medical Monitor in the execution of Clinical Development functions. Responsibilities Study Strategy: Drafts development plan under… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … clinical activities as appropriate.Responsibilities Clinical Operations Study / Program ManagementCompany Sponsored Studies (CSS) Support the preparation, ... clinical operations systems for management of company sponsored studies review and approvals are current and accurate.Liaison and...key activities and expectations. Ensure regular updates provided to Study Lead on trial metrics, data, and… more
- Merck & Co. (North Wales, PA)
- …provides support across all elements of management and execution of non-interventional studies and research activities. This position, under the supervision of a ... Research Management Team Lead , will execute a variety of research management activities...execute a variety of research management activities starting from study execution to close-out and summarization of results from… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …establishing data collection, data standards and data cleaning needs for DS Programs / Studies .Serve as the subject matter expert for Study Data Managers during ... of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical...to support the collection of diverse external data types.Advises Study Data Manager on complex vendor management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium ... and immune disorders. Summary Position leads statistical support for medium complexity studies including contributing to development of optimal study design,… 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. ResponsibilitiesPerform all ... well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the… more
- Novo Nordisk Inc. (Atlanta, GA)
- …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 cultivated and positioning Novo Nordisk as the leader in the obesity… more
- Eisai, Inc (NJ)
- …this is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 ... Programs. As the Lead Medical Writer, the incumbent ensures timely completion, accuracy...incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... disabilities.SummaryThis position supports early phase oncology development and leads complex studies in study design, statistical analysis and interpretation of… 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 the ... role will consist of these components including: Expand and lead our Data Stewardship Working Group (DSWG) across functional...cleansing and standardizing data, with a focus on eg, clinical , product, and vendor data and Identify and rectify… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and support the PRA strategies and tactics of additional indications. With manager oversight, the individual will lead global pricing strategy development, ... global functions including but not limited to Commercial, Marketing, Medical, Clinical Development, Public & Government Affairs.Responsibilities- Lead the… more
- Aequor (Thousand Oaks, CA)
- …regulatory guidelines impacting supply (ie GxP, SOX) High attention to detail Understanding of clinical study conduct Ability to operate in a team or matrixed ... remote schedule and be available at the committed times. Qualities/characteristics the hiring manager is looking for in candidates to work best with their team:… more
- The University of Vermont Health Network (Berlin, VT)
- …working in the Radiology Department. POSITION SUMMARYAt the administrative direction of the Director/ Manager / Team Lead , and the clinical direction of the ... Radiologist, our Certified Nuclear Technologist:Perform diagnostic studies utilizing radiopharmaceuticals and imaging equipment with minimum supervision.Assay and… more
- IQVIA (Durham, NC)
- …teams to improve patients' lives by bringing new drugs to the market faster. The Senior Clinical Lead is a member of the core project team responsible for ... clinical delivery of full service, large, multi-regional ...out of scope work. * Work as the primary Clinical Lead alongside other Clinical ...work. * Work as the primary Clinical Lead alongside other Clinical Leads to deliver… more
- Regeneron Pharmaceuticals (Armonk, NY)
- As a Clinical Study Lead (CSL),...studies + Oversees and provides input to the study drug and clinical supplies forecasting, drug ... NJ or Armonk, NY._ **A typical day as a Clinical Study Lead looks like:**...implement the operational strategic direction and guidance for respective clinical studies + A data driven approach… more
- Regeneron Pharmaceuticals (Armonk, NY)
- The **Senior Clinical Study Lead ** (CSL)...studies + Oversees and provides input to the study drug and clinical supplies forecasting, drug ... in this role looks like:** + Leads the cross-functional study team responsible for clinical study...implements the operational strategic direction and guidance for respective clinical studies + Demonstrates expert knowledge and… more
- Abbott (Pleasanton, CA)
- …products and/or respond to questions from regulatory authorities about existing submissions + Lead publications for clinical study data through coordination ... Failure. The job purpose and scope of the Senior Manager , Clinical Science is to lead...monitoring. This position will work closely within the cross-functional clinical study team including project management, medical… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- We are seeking a **Senior Manager , Clinical Sciences** to lead in the development, evaluation, planning and execution of clinical studies and ensures ... and interpretation of study data of a clinical development program. The Senior Manager reports...provide scientific expertise necessary to design and deliver on clinical studies and programs. We hope you… more
