- 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
- 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
- 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
- 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
- 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
- Merck & Co. (North Wales, PA)
- …a clinical trial.May serve as the clinical trial team leadMay lead team in key study planning, development, and execution elements (eg, data management ... study team, country teams, vendors, committees) in support of clinical study objectives.Accountable for managing any study specific partners and/or… 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
- IQVIA (Bridgewater, NJ)
- …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 (Basking Ridge, NJ)
- 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 (Basking Ridge, NJ)
- 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …NJ._ A Clinical Study Associate Manager (CSAM) role supports the Clinical Study Lead (CSL) by taking responsibility for areas of clinical ... sites may be required to assist with monitoring clinical studies . **A typical day as CSAM...regular status reports to stakeholders as requested by the Clinical Study Lead + Contributes… more
- Taiho Oncology (Princeton, NJ)
- Sr. Study Manager , Clinical Operations...need it most. This is an exciting opportunity to lead clinical studies and experience ... support the Clinical Development Plan. The Senior Study Manager (SSM) is responsible for ensuring... Manager (SSM) is responsible for ensuring assigned clinical studies are delivered within timelines, budget,… more
- Pfizer (New York, NY)
- … close. The Study Operations Manager has responsibility for study management aspects of assigned studies of limited complexity (eg single country, ... Manager , Study Start Up Project Manager , Site Intelligence Lead , Country Trial ...of the Local Study Team (core members: ( Lead ) Site Care Partners Clinical Trial Assistant,… more
- Merck (Trenton, NJ)
- **Job Description** **Position Description:** **Senior Study Manager - Cardiometabolic** Our Clinical Research and Pharmacovigilance team push the boundaries ... and execution of a clinical protocol. May lead team in key study planning, development...and close out visits + Experience as a CRA Manager , Lead CRA or Project Manager… more
- Merck (North Wales, PA)
- …+ May serve as the clinical trial team lead + May lead team in key study planning, development, and execution elements (eg, data management deliverables, ... (eg, study team, country teams, vendors, committees) in support of clinical study objectives. + Accountable for managing any study specific partners… more
