- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Functional Expertise:Reviews/approves clinical study related documents (eg, Protocols, Data Management Plan, Clinical Study Reports).Leads and ... diseases and immune disorders. Summary Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs… more
- Merck & Co. (Rahway, NJ)
- …or more of the areas of Drug Substance development, Drug Product development, Clinical Supply management or Analytical Research is critical for understanding ... to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities ... from external sources.Ensure prompt and thorough review of requests for de-identified company clinical trial data .Ensure company clinical trial data … 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
- Novo Nordisk Inc. (WA)
- …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)
- … trials. This position will work closely with other members of the Biostatistics and Data Management teams on various clinical projects and may function as ... areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data ... data review listings and reports to support Data Management and clinical teams.Develop,… 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and stewardship communities across Daiichi Sankyo.- Remaining aware of and champion emerging data management skills and capabilities, including data quality, ... research areas centered around rare diseases and immune disorders.SummaryThis Data Governance Communications Manager will be a...master data management , metadata management , data change management and… 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 overall ... ensures continuity of site relationships through all-phases of the trial.Performs clinical study site management /monitoring activities in compliance with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory ... Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting, and analytics for RA. This will include working within and optimizing… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a difference? The Position Provides tactical leadership to staff, within the Trial Management (TM) function of North America Clinical Operations (NACO). Takes ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North America Clinical … more
- Merck & Co. (North Wales, PA)
- …lead team in key study planning, development, and execution elements (eg, data management deliverables, trial level plans/timelines, country/site selection, site ... PowerPoint, Word, Outlook, etc.)Education/ExperienceBachelor's Degree +5 years of pharmaceutical, clinical drug development, project management , and/or medical… more
- Merck & Co. (North Wales, PA)
- …team in key study planning, development and execution elements (eg, data management deliverables, protocol level plans/timelines, country/site selection, system ... Job DescriptionPosition Description: Senior Study Manager - Cardiometabolic Our Clinical Research... trial team (CTT) lead. -Leads team for timeline management , risk identification and mitigation, issue resolution.- May facilitate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Associate Manager will support CMR's partnership and alliance contract management strategy with a focus on: Partnering with stakeholders across CMR to plan, ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… 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...ready to make a difference? The Position The Project Manager , Accelerated Efficiencies and Optimization, will drive execution of… 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
- Novo Nordisk Inc. (Atlanta, GA)
- …individuals and teams to consistently perform at a high level Mastery knowledge of the clinical management of obesity and the range of treatment option We commit ... sales strategies within obesity accounts, utilizing a patient-centric and clinical approach to selling to ensure strong relationships are...items Ensure timely and accurate transmission of OCS call data Monitor and reinforce the use of the Sales… more
- Merck & Co. (North Wales, PA)
- …of all Supplier documents such as monitoring, project management , safety management , data management and validation plans.Participate in protocol and ... exchange, improving access and health outcomes for patients. The Research Management Operations team sits within the Real-World Evidence (RWE) Operations… more
