- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management ... are not limited to: All responsibilities of a Senior Clinical Data Manager (SCDM) and a ...to identify and incorporate global operational issues into the study design.Execute and trigger communications and escalations at the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … clinical activities as appropriate.Responsibilities Clinical Operations Study / Program ManagementCompany Sponsored Studies (CSS) Support the preparation, ... the global clinical operations systems for management of company sponsored studies review and approvals are current and accurate.Liaison and reporting on … more
- Merck & Co. (Rahway, NJ)
- …of Clinical Trial Research Agreements (CTRA).Oversees and tracks clinical research-related payments. Payment reconciliation at study closeout. Oversees ... quality standards and adverse event reporting requirements internally and externally.Our Clinical Research and Pharmacovigilance team push the boundaries of global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders.Summary This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This position ... and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and the Clinical... protocols to ensure consistency in safety requirements across studies related to a similar compound. Develops and maintains… 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 ... on SDV plan. Performs literature review and creates reference list for study . Study Planning: Contributes to clinical trial planning including identification… 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 ... as a project manager for other activities involving assigned product(s) or clinical studies , as needed Qualifications: Successful candidates will be able to… more
- Merck & Co. (Rahway, NJ)
- …Provides ongoing clinical database support to other departments. Assist clinical database manager /supervisor in project planning, manpower projections and ... resource allocations across therapy areas. Interface with clinical database manager /supervisor to assure consistency of technical and process strategies across… more
- FISI - FUJIFILM Irvine Scientific (Santa Ana, CA)
- …significant time pressures.Strong scientific and medical writing skills.Knowledge in writing clinical study reports, integrated summaries of safety and ... Overview We are hiring a Clinical Affairs Program Manager . The Clinical Affairs Program Manager will be responsible for the development and generation of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the ... Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ...milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the ... Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ...milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).ResponsibilitiesReconcile the TMF… more
- Merck & Co. (North Wales, PA)
- …country teams, vendors, committees, investigators, site personnel, etc.) in support of clinical study objectives.- Accountable for managing any study ... innovative medicine.Accountable for the operational planning, feasibility, and execution of a clinical protocol.- May lead team in key study planning,… more
- Merck & Co. (North Wales, PA)
- …the strategy and leads the operational planning and execution of one or more clinical trials. In this position, you will have the opportunity to demonstrate your ... management, communication, and collaboration skills in support of our clinical trials. Job Responsibilities Responsible for the operational planning, feasibility,… more
- Merck & Co. (Rahway, NJ)
- …Division Oncology Clinical Development.Forecast grant spend related to Oncology clinical studies , as well as providing financial support related to ... assigned clinical studies . Be the primary point of...Plan, Quarterly Forecasts, and monthly/quarterly close activities at the clinical study level.Other responsibilities include but are… more
- Eisai, Inc (Nutley, NJ)
- …led by Translational Science to evaluate biomarkers across programs, as well as the study statistician for clinical studies . As the statistical lead for ... managing CROs. The immediate need is to manage early clinical development studies primarily in support of...conduct to proactively address issues to ensure high quality study data (as needed). Clinical Study … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Management:Is accountable for the conduct of data monitoring and validation activities for assigned studies during study startup, study conduct or study ... to provide reporting and validation expertise to the assigned Daiichi Sankyo portfolio of studies . Function as technical resource to the study teams for data… more
- Merck & Co. (North Wales, PA)
- …with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates in the set up ... Job DescriptionThis position drives scientific planning, strategy and execution of Phase 1-4 clinical studies .-Under the direction of the Program Lead, you will… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...management systems and archiving systems. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships… more
- Novo Nordisk Inc. (Atlanta, GA)
- …North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...leveraging competencies, tools and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships… 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
