- 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)
- …profile throughout product lifecycle Independently leads activities without supervision for assigned clinical studies Lead activities under the direction of ... clinical studies in partnership with Clinical Safety Scientist Product Lead , Product Safety... studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and review Statistical… 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)
- …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)
- …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)
- …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)
- …Order process, bid defense meetings, and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when applicable. Serve as ... of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and...standards team as an extended part of committee. Advise Study Data Manager on complex vendor management… 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
- 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
- Actalent (Basking Ridge, NJ)
- …growing! Summary: The Clinical Study Associate Manager role supports the Clinical Study Lead by taking responsibility for areas of clinical ... versus oversight of CROs deliverables will vary accordingly. The Clinical Study Associate Manager works... sites may be required to assist with monitoring clinical studies . Qualifications: + 5+ years of… 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
- Actalent (Bernardsville, NJ)
- Description: As a Clinical Study Lead (CSL),...studies + Oversees and provides input to the study drug and clinical supplies forecasting, drug ... you will lead the cross-functional study team responsible for the global execution of large,...Management of vendors and CROs + Leads the cross-functional study team responsible for clinical study… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …of GOMA clinical activities as appropriate. **Responsibilities** _Clinical Operations Study / Program ManagementCompany Sponsored Studies (CSS)_ + Support the ... 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
- Actalent (Morristown, NJ)
- …tasks for assigned study . + Coordinate, lead and perform clinical data management activities for assigned studies in accordance with Regeneron's SOPs ... candidates are invented and developed in house! Description: + Clinical Data Manager who will work collaboratively...are performed in compliance with regulations and according to study protocol and the Study Data Management… more
- Bausch Health (Bridgewater, NJ)
- …health care products. **Overview** Responsible for the implementation and oversight of clinical study or program operations by organizing and coordinating with ... other relevant parties the planning, implementation, management, execution and completion of clinical studies or programs according to applicable regulations and… more
