- 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 ... clinical trials, including but not limited to: data management tool and system development, validation...are not limited to: All responsibilities of a Senior Clinical Data Manager (SCDM) and… 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)
- …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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for quality, performance, regulatory compliance, and patient safety related to managing assigned clinical trials, document management and management of ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...start up through closure, including but not limited to: Management of clinical trial documents, including but… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with disabilities. Summary This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical ... (SME) Involved in audits/inspections for safety surveillance and risk management for assigned clinical studies, through inspection... Clinical Safety Scientist Lead and PSL or Clinical safety physician(s) to evaluate safety data … 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)
- …operations, oversight of initiatives and trouble-shooting issues. Liaison for CS Physician and Data Management for study related safety reporting. Will also act ... Operations. This position develops SAE Flow Plans and electronic data capture (EDC) Safety report outputs, reviews clinical... Data Capture (EDC) Responsibility: In conjunction with Data Management , establish the EDC strategy at… 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
- Merck & Co. (Rahway, NJ)
- …checks, and scripts to aid in transfer of electronic data files into the Clinical Data Management System (CDMS). Leads and participates in the review of ... transfer of electronic data files into the Clinical Data Management System (CDMS).... clinical database support to other departments. Assist clinical database manager /supervisor in project planning, manpower… 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
- Merck & Co. (North Wales, PA)
- …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
- 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
- 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 DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries... trial team (CTT) lead. -Leads team for timeline management , risk identification and mitigation, issue resolution.- May facilitate… more
- Insmed Incorporated (Bridgewater, NJ)
- …a liaison with biostatistics to obtain additional data , and overall driving project management to meet deadlines. The Senior Manager is expected to own their ... to corporate policies and external regulations and guidance. The Senior Manager , Scientific Communications & Publications, provides support to the Associate… more
- Aequor (Piscataway, NJ)
- …The S/MMC is expected to: Possess ability to understand and interpret clinical trial data , the literature and associated therapeutic conditions Coordinates ... Job Title: Manager /Sr. Manager Medical Communications Hybrid schedule:...publications and scientific congress strategy and plans Possess project management skills to ensure execution of publication plans is… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the quarterly global consolidation, supporting both external reporting and internal management financial reporting for a collaboration program. This position has ... - Manage and is accountable for the development of Clinical Project Budget templates in support of early phase...consolidation process and preparation of financial packages to senior management and to external party for the collaboration program.… more
- Lundbeck (South Bend, IN)
- …and psychiatry. Join us on our journey of growth!As a Psychiatry Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... strategies with comprehensive clinical knowledge to drive sales performance. Our Account Managers...Leadership - Ability to use digital tools and apply data -based insights to create opportunities, develop strategy & tactics,… more
