- 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 ... pertaining to clinical trials, including but not limited to: data management tool and system development, validation and maintenance, data integrity… more
- Merck & Co. (North Wales, PA)
- …systems data (eg our company's IT data hub - InForm, DMW, Clinical Data Repository (CDR), Site Management Authoring and Reporting Tool (SMART) and ... including conflict resolution expertise and discretion.Preferred: Cross-functional experience in clinical research (eg, monitoring, data management ,… more
- Merck & Co. (Rahway, NJ)
- …enhance standards and associated processes for growth opportunitiesThe Vocabulary Specialist may lead or participate in:Internal clinical data standards ... existing and pipeline products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director, is a… 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, ... , is accountable for an end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical...data sets and identifies any erroneous data . Lead Companion Diagnostics data management … 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
- 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 ... or complex disease required- 7+ years working knowledge of Clinical trial data systems and/or EDC lab management tools is a plus preferred Daiichi… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Merck & Co. (North Wales, PA)
- …trial scientific-activities.Job ResponsibilitiesResponsible for the clinical /scientific execution of clinical protocol(s).Serves as the lead clinical ... set up) Lead medical monitoring team in review and interpretation of clinical data /medical protocol-deviations in collaboration with the Clinical … 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 ... tracking of milestones as per contract). Ensure the global clinical operations systems for management of company...activities and expectations. Ensure regular updates provided to Study Lead on trial metrics, data , and quality.Establish… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as ... to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible for the management of technology transfer of the ... recommends, and implements new technologies, as needed and supports Supply Chain Management with technical issues post first CPV.Responsibilities- Lead and… 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. (North Wales, PA)
- …the position:Serve as a statistical representative and core member in the Risk Management Safety Teams.- Lead and provide statistical support for related ... and data processing software eg SAS and/or R.-Good project management skills. --Good understanding of worldwide regulatory requirements and clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …working on projects/studies and/or initiatives. Lead and manage the standardized Data Management Process and Procedures for consistency across programs and ... and immune disorders. Summary Position manages the end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of the activities in the GMA plan including Launch Readiness and Life Cycle Management for the assigned compound and will report into the Global Oncology Medical ... development, execution of the Global Medical Affairs plan and budget management including activities related to evidence generation, scientific engagement and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Director, Clinical Safety, will be a product safety lead or part of a ... , and provide safety leadership including but not limited to clinical studies, post-marketing surveillance, signal detection and management , important… more
- Lundbeck (MA)
- …United States in close proximity to a major airportPOSITION SUMMARY:The Field Medical Lead - Neurology (East) will lead , coach, train, and provide direction ... defined medical strategies and tactics across assigned products. This role will lead either general MSL training or Field Medical insight generation, distillation,… 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 ... role will consist of these components including: Expand and lead our Data Stewardship Working Group (DSWG)...program, data stewardship program or similar intent data management program focused on setting standards,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 the defined,… more
- Daiichi Sankyo, Inc. (Munich, ND)
- …oncology early development studies, functional lines including, global regulatory operations, biostatics, data management , clinical science and clinical ... trends, issues and risks across the network sites.Utilizes site performance and quality data to optimize prioritization of oversight.The Network Lead reports to… more
