- Merck & Co. (Rahway, NJ)
- …and clinical outcomes assessments.2. Serves as project manager of all clinical data management activities for trials as assigned.- Under the guidance ... Job DescriptionThe Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a… more
- Option Care Health (Columbus, OH)
- …about clientele. Employee will further help to manage this system and review such data to create marketing reports for Management Team and base sales campaigns ... and chronic conditions in all 50 states. Through our clinical leadership, expertise and national scale, Option Care Health...and materials that reflect the analysis of prior marketing data to build on the success or failure of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …requirements.Functional Expertise:Reviews/approves clinical study related documents (eg, Protocols, Data Management Plan, Clinical Study Reports).Leads ... diseases and immune disorders. Summary Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …required.Knowledge of CDISC and SDTM and industry standard data collection practices. Clinical data management experience in a medical device, ... employer including veterans and people with disabilities. Summary The Manager External Data Management , is..., is accountable for an end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical… more
- Novo Nordisk Inc. (San Antonio, TX)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... strategies Implements proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …monitoring plans.Accountable for accuracy and timeliness of information in all data management activities, databases and tracking systems.Company Sponsored ... review, Global review, tracking of milestones as per contract). Ensure the global clinical operations systems for management of company sponsored studies review… more
- Merck & Co. (North Wales, PA)
- …(eg, database set up)Lead medical monitoring team in review and interpretation of clinical data /medical protocol deviations in collaboration with the Clinical ... the clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs ... Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan.… more
- Merck & Co. (Rahway, NJ)
- …reporting requirements internally and externally. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking ... sites in a country.Under the oversight of the CRA manager or CRD, the person ensures compliance of study...of site relationships through all phases of the trial.Performs clinical study site management /monitoring activities in compliance… more
- Merck & Co. (North Wales, PA)
- …of our existing and pipeline products to produce safe, effective, innovative medicine.The Clinical Sciences & Study Management (CSSM) department is building the ... Clinical Trial Team (CTT)May work closely with the Medical Writer on clinical /scientific and regulatory documents and the Study Manager on study… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a difference? The Position Drives the understanding & delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; scientific ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...minimum of 2 years of direct expertise of site management and logistical execution of clinical trials… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and SDTM and industry standard data collection practices preferred- 7+ years Clinical data management experience in a medical device, pharmaceutical ... team as an extended part of committee. Advise Study Data Manager on complex vendor management...7+ years working knowledge of Clinical trial data systems and/or EDC lab management tools… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … stewardship and governance processes, data cataloging data standards, data quality, and data management .- Develop and implement strategies for ... areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work...program, data stewardship program or similar intent data management program focused on setting standards,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …vendor project timelines and resource planning, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis ... Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and support data review, review analysis dataset… more
- Eisai, Inc (Nutley, NJ)
- …monitors study conduct to proactively address issues to ensure high quality study data (as needed). Clinical Study Report - provides statistical and validation ... want to hear from you. Job Summary The Senior Manager , Translational Science Biostatistics will be expected to work...efforts of Translational Science to generate useful human biomarker data sets from internal (eg clinical samples,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …negotiation, preparation, and execution of master agreements on a timely basis. Management and oversight of Clinical Development contracting process, review and ... management skills preferred.Experience with PH.1 - PH. IV clinical trial vendor contracts required.Experience with CRO contracts preferred.Demonstrated ability… more
- Merck & Co. (North Wales, PA)
- …least 2 years of experience in publication managementUnderstanding of the clinical development process andclinical study data for assigned ... Job DescriptionOverview:The Associate Director Publication (Pub) Manager is the central source of information regarding publication activities and is responsible for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...difference? The Position The CMR Business Planning & Strategy Manager will be responsible for facilitating the creation and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
