- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders.Summary This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This position develops SAE ... Plans and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and the Clinical Study Oversight Plan,day-to-day management of… more
- Merck & Co. (North Wales, PA)
- …the Clinical Trial Team leadLeads and directs teams in key study planning, development, and execution elements (eg operational reviews, issue escalation/mitigations, ... governance).Responsible for facilitating and collaborating with key internal/external stakeholders ( study team, subsidiary country teams, vendors, committees, etc.) in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the Study Associate Manager within Clinical ... archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key study documents to the… more
- Eisai, Inc (Nutley, NJ)
- …by Translational Science to evaluate biomarkers across programs, as well as the study statistician for clinical studies . As the statistical lead for biomarker ... your profile, we want to hear from you. Job Summary The Senior Manager , Translational Science Biostatistics will be expected to work independently with minimal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …assigned clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and review Statistical Analysis Plans (SAPs) and statistical outputs ... supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead, Product Safety… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Clinical Research Manager (aCRM) - Oncology With support of other Clinical Research Manager 's (CRMs) and/or ... requirements internally and externally.The aCRM could be responsible for a particular study for a country or a cluster.Responsibilities include, but are not limited… 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 ... optimal approaches to support the collection of diverse external data types.Advises Study Data Manager on complex vendor management issues and provides… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary Position leads statistical support for medium complexity studies including contributing to development of optimal study design, ... study report (CSR): Leads statistical activities for medium complexity studies including study design, protocol development, CRF review, SAP development,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …milestones of GOMA clinical activities as appropriate.Responsibilities Clinical Operations Study / Program ManagementCompany Sponsored Studies (CSS) Support the ... execution of all Global Oncology Medical Affairs (GOMA) Company Sponsored Studies (CSS) and Medical Access/Expanded Access (MAP)/(EAP)activities in adherence to Good… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the Study Associate Manager within Clinical ... archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key study documents to the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member with other functions, ARO, CRO. ... along with CSL and/or Medical Monitor to development of study design to meet study objectives, development...to development of study design to meet study objectives, development of biomarker/PK strategy in collaboration with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …TLFs generated by statistical vendor, ensure deliverable quality for the pivotal studies , Integrated Summary of Efficacy (ISE)/Integrated Summary of Safety (ISS) for ... submissions. Responsibilities include: review Case Report Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOverview:The Associate Director Publication (Pub) Manager is the central source of information regarding publication activities and is responsible for ... global publication strategies and tactical plans. The Associate Director Pub Manager oversees compliance with our company's publication policies and procedures and… more
- Eisai, Inc (NJ)
- …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. ... clinical regulatory documents and submissions for own area of study / program/ marketing application, with directionExperience managing multiple projects by… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disabilities.SummaryThis position supports early phase oncology development and leads complex studies in study design, statistical analysis and interpretation of ... and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development,… more
- Merck & Co. (Rahway, NJ)
- …(CTRA).Oversees and tracks clinical research-related payments. Payment reconciliation at study closeout. Oversees FCPA, DPS/OFAC, and maintenance of financial ... can deliver country-specific trial commitments and objectives especially during study start-up.Required to in/directly influence investigators, external partners and… more
- Merck & Co. (Rahway, NJ)
- …DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management activities ... limited to: All responsibilities of a Senior Clinical Data Manager (SCDM) and a Clinical Data Manager ...to identify and incorporate global operational issues into the study design.Execute and trigger communications and escalations at the… more
- Aequor (Thousand Oaks, CA)
- FULLY REMOTE Regulatory Writing Senior Manager ln this vital role role you will serve as the functional area lead on product teams, lead writing activities for ... the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. Summary Position leads complex studies in study design, statistical analysis and interpretation of results ... and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for a smooth consolidation process. Also responsible for managing various studies including late stage budget and forecasting, analysis, strategic planning, internal ... Project Budget templates in support of early phase to late stage clinical studies . Accountable for the control and reporting of GEMRAD approved budgets. On a… more
