- 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
- Daiichi Sankyo, Inc. (Munich, ND)
- … early development studies, functional lines including, global regulatory operations, biostatics, data management , clinical science and clinical ... research areas centered around rare diseases and immune disorders. Summary The Oncology Early Development Center (OEDC) Network Lead is 100% dedicated to OEDC and… 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...development for Daiichi Sankyo Programs.Lead the Data Management aspects of diagnostics across Daiichi's early … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …standards, (v) encouraging innovation.Build strong relationships with clinical development, clinical sciences, regulatory, biostats, data management , and ... centered around rare diseases and immune disorders.Summary The Executive Director, Global Clinical Operations Study Management Group Head has leadership and… 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. (North Wales, PA)
- … Clinical Safety StatisticsInteract with Safety Physicians, Safety Scientists, Clinical Trial Physicians , Regulatory, Early /Late Development Statistics, ... and data processing software eg SAS and/or R.-Good project management skills. --Good understanding of worldwide regulatory requirements and clinical … more
- Insmed Incorporated (Bridgewater, NJ)
- …statistical analysis. Collaborate with team in the development and implementation of Data Management activities including development of eCRFs, edit checks, ... representing the company in outside groups.Contribute to the strategic development of early and late stage clinical programs.QualificationsRequires an MD or… more
- Eisai, Inc (Nutley, NJ)
- …required for responses, and managing CROs. The immediate need is to manage early clinical development studies primarily in support of Translational Science and ... operational aspects of the groups in support of multiple early clinical development studies. PCS / ...to proactively address issues to ensure high quality study data (as needed). Clinical Study Report - provides… more
- Merck & Co. (Rahway, NJ)
- …data standards, taxonomies, and ontologies to ensure consistent and accurate data representation. Data Management and Integration:Oversee the management ... to integrate instrument-generated data and experimental workflows into data management systems.Ensure seamless interoperability between instruments, software… more
- Merck & Co. (Rahway, NJ)
- …related drug/vaccine projects in Late Development Statistics.Lead the interaction with Clinical , Regulatory, Statistical Programming, Data Management , and ... assigned to a development project as neededLead biostatistics in early or late clinical development planning to...design and analysis of clinical trialsStrong project management skills. --Solid knowledge of-statistical and data … more
- Merck & Co. (Rahway, NJ)
- …you will be part of a team develop ing innovative analytical methodologies for early to late phase pro grams with application to drug substance and a broad ... combination products and modalities through analytical characterization, imaging tools, and data analy sis. You would also contribute towards regulatory submissions… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Project Planning and Forecasting - Manage and is accountable for the development of Clinical Project Budget templates in support of early phase to late stage ... the quarterly global consolidation, supporting both external reporting and internal management financial reporting for a collaboration program. This position has… more
- Merck & Co. (North Wales, PA)
- …least 2 years of experience in publication managementUnderstanding of the clinical development process andclinical study data for assigned ... input regarding the selection of appropriate journals and congresses for scientific data dissemination. They work closely with both internal writing staff and… 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 ... annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and support data review, review...Having knowledge of all phases of drug development, including early and late phase clinical development and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …practices and record retention processes, particularly those used in Biostatistics and Data Management groups. Daiichi Sankyo, Inc. is an equal ... monitor reviewer metrics for quality control in support of clinical trial endpoint data , and collaborate with...5 years of experience in imaging operations in oncology clinical development of both early and late… more
- Catalent (San Diego, CA)
- …biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more ... analytical understanding and learn the common operations in a fast-paced, early Phase-focused, dynamic Quality Control group.This is a full-time position: Monday… more
- Novo Nordisk Inc. (Boulder, CO)
- …in Lexington, Watertown and Cambridge reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building ... with the Digital, Data and IT (DDIT) organization, DDIT Research and Early Development (DDIT RED) and coordinating with colleagues in NN global research hubs and… more
- Catalent (Philadelphia, PA)
- …authorities.The Director of Quality is responsible for providing leadership and Quality Management support within each of the Clinical development supply ... biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more… more
- Merck & Co. (North Wales, PA)
- …communication skills (written and oral) in addition to results-oriented project management skills Preferred experience and skills: Deep clinical expertise ... and regionsServes as an impactful member of Product Development Team sub-teams ( Clinical , Value Evidence, Commercial, Publications and Label) and Global Human Health… more
- Eisai, Inc (Exton, PA)
- …will also serve as a scientific and technical resource to support several early to late stage manufacturing programs.This position will be responsible for the review ... and interpretation of analytical testing data as well as protocols and reports, with an...knowledge of the regulatory requirements at each stage of clinical development is essential.This position will have a direct… more
