- Eisai, Inc (Nutley, NJ)
- …programs/tools to facilitate the statistical analysis of biomedical or related data .Demonstrated excellence in complex project management , showcasing the ability ... and priorities.Extensive experience collaborating with vendors to ensure the successful delivery of data and programming requirements.Expert-level of knowledge… more
- Eisai, Inc (Nutley, NJ)
- …driving results with multiple projects across several functional areas; Portfolio management , project planning, development, and delivery ; Managing projects in ... Master's degree or foreign equivalent in Computer Science, Information Technology Management , or Business Administration or closely related field plus 2 years… more
- Eisai, Inc (Nutley, NJ)
- …to understand and evaluate the implications of clinical trials and real-world data ; demonstrate the value of interventions beyond efficacy, and assess benefits, ... training and support of staff. Some travel may be required for project management and/or business development.The incumbent is expected to be a team player, and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Director Data Product Management Job Description We are seeking a strong, highly energetic and collaborative ... " Data First" commercial biopharma organization.In this Associate Director Data Product Management role,... Data Solutions team and lead Digital Product Management capabilities role, driving shaping and delivery … more
- Merck & Co. (Rahway, NJ)
- …Global Template asset, delivering enterprise-level capabilities through harmonized business processes and data .- The team is responsible for the operation of all our ... integrated solutions, governance of the associated enterprise assets, and cost-effective delivery of capabilities to support achievement of immediate and future… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and people with disabilities. Summary The Associate Director , External Data Management , is accountable for the end-to-end delivery of External data ... - Project Management : Is accountable for quality of delivery in external data management activities under the outsourced and in-house operating… more
- Merck & Co. (Rahway, NJ)
- …with cross functional scientists including, Statistics, Clinical, Regulatory, QP2, CSRM, Data Management and Statistical Programming to plan for the ... Job DescriptionResponsibilities:Responsible for both people and project management and is accountable to set strategy for... and is accountable to set strategy for the delivery of high quality and compliant statistical analysis and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary Position manages the end-to-end delivery of data management services for assigned projects/studies, ... drug development processes and global submissions. This position provides leadership within Data Management by partnering with internal and external stakeholders… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and external stakeholders communicating ... Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strong relationships with clinical development, clinical sciences, regulatory, biostats, data management , and other key stakeholder peer functions ... research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation of developmental and ... with CSPV to ensure monitoring / reporting of AEs/SAEs, Reviews safety reports/ data during study conduct, Provides and documents oversight of medical monitoring… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to end in collaboration with GCLs, Physician Scientists and the study team ( data management , clinical operation and other functions) to implement clinical ... programs.Partner and collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management , Regulatory Affairs, and other RD functions to ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ADaM data set specifications, reviewer's guides, etc- Global Biostatistics Data Management (BDM) Strategy to Improve Drug Development: Leads implementation ... close collaboration with other functional areas such as biostatistics, data management , clinical operations, pharmacovigilance, regulatory affairs,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ownership of their learning plans. The ideal candidate will be creative, data driven, and learner-obsessed with experience in developing and managing a learning ... program from content to delivery . ** Prior to applying, review the Education &...technical learning solutions and other performance enhancement solutions (eg, management reinforcement, rewards, role clarity, job aids).- Facilitates scientific… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …perspective; Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior ... the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population...Phase 3 registrational study(ies); Develop prospective contingency plans for management of key risks in a large study or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ADaM data set specifications, reviewer's guides, etc.- Global Biostatistics Data Management (BDM) Strategy to Improve Drug Development: Leads implementation ... Collaboration: Provide leadership for strategic and process improvement initiatives within Biostatistics Data Management . Works with colleagues at DST and DSE to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data ... of trial, clinical trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input on ICF creation;… more
- Eisai, Inc (Nutley, NJ)
- …and industry policies (ie policies/procedures, resource utilization, sales and account data , etc.)Continuously align with Regional Business Director to support ... to secure product access through effective P&T coordination and process management . This individual will also be responsible for fostering key stakeholder… more
- Merck & Co. (Rahway, NJ)
- …of our medicines, vaccines, and Animal Health products.Position Description: Associate Director , Software Asset Management (SAM)The Associate Director , ... hybrid team of employees and outsourced SAM service providers, reporting to the Director , Business Consulting in the Business Management & Enablement team.Key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …perspective; Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior ... with CSPV to ensure monitoring / reporting of AEs/SAEs, Reviews safety reports/ data during study conduct, Provides and documents oversight of medical monitoring… more
