- Eisai, Inc (Nutley, NJ)
- …user support to other areas of Data Operations, Data Management, Clinical Safety Data Review and Clinical team. The Assoc. Director of Clinical Programming will ... profile, we want to hear from you. The Associate Director , Clinical Programming must have expertise in addressing technical...and SAS program development for clinical data processing, data review reports and listings. This includes but is not… more
- Eisai, Inc (Exton, PA)
- …If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and building a ... technology transfer to external partners (as required). The Associate Director sets strategic directions and project priorities, providing scientific leadership… more
- Merck & Co. (Durham, NC)
- …resource and operational challenges.Decisions are guided by policies, procedures, engineering design guidelines and business plan ; receives guidance from manager ... Job DescriptionThe Associate Director , Utilities Electrical Engineer is a member of...Vaccine Technology (GVTE), Automation, and Quality approvers.-Perform a thorough review of design & engineering records and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary:The Associate Director , Oncology Value & Market Dynamics Training Manager is responsible for ... developing & deploying a strategic training plan that equips our teams with advanced skills and...for patients across our portfolio of products. The Associate Director will develop, in partnership with other key stakeholders,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the vision and ... disciplines and cultures. Must have technical knowledge on integrated data review and derivation/interpretation of metrics that can dynamically interface with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... the effective strategy, design , execution, and interpretation of Oncology clinical trials. Position...Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study team, lead the study team to develop a cross-functional, integrated study plan and create initial study budget. Review study feasibility assessments ... level. Responsible for clinical program planning and execution (from study design , operational planning, start-up, conduct, reporting, and close out) including… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …solve complex study problems.Responsibilities:Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, ... (CSR): Leads statistical activities for complex studies including study design , protocol development, CRF review , SAP development,...Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …typically a single non-pivotal trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates ... Ops for EDC, edit checks, data quality listings, SAP, Data Management plan ; Reviews patient population and protocol compliance for consistency with study strategy;… more
- Merck & Co. (Durham, NC)
- …facility will include end-to-end processing of drug substances.As the team finishes the design and construction of the facility, the Operations Manager will play a ... have the unique opportunity to give input in the design process, startup their areas, and lead the teams...other supervisors.Decisions are guided by policies, procedures and business plan - Receives guidance and oversight from Operations Associate… more
