- Genmab (NJ)
- … Data Management is operationally responsible for the oversight of Clinical Data Management activities related to the effective planning, and ... excellence.Responsibilities:Contributes to and implements the strategic direction of the Clinical Data Management functional areaContributes to the… more
- Merck & Co. (Rahway, NJ)
- …efficiency of our clinical research operations.Key Responsibilities:- Lead Data Management Initiatives:-Direct the development and maintenance of ... edit checks to maintain the integrity and consistency of data .- Discrepancy Management :-Collaborate with Clinical ...international equivalent) in Data Management , Management Information Systems (MIS), Biological or Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Certification - Certified MedDRA Coder (CMC) or equivalent preferred Experience:4+ years of clinical data management medical coding experience in a medical ... coding requirements such as eCRF Specifications, listings, coding conventions, Data Management Plan, and dictionary coding synonym...MedDRA, and WHO not DD is requiredWorking knowledge of Clinical trial data systems and/or EDC coding… more
- Merck & Co. (Rahway, NJ)
- …plans which describe the methodology to be programmed; applying statistical terminology and clinical data management concepts; CDISC SDTM and ADaM standards; ... clinical studies using deep scientific knowledge, statistical analysis and high-quality data to support decision making in clinical trials.Responsible for the… more
- Merck & Co. (North Wales, PA)
- …to be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM ... experience in developing analysis and reporting deliverables for R&D projects ( data , analyses, tables, graphics, listings)Strong project management skills;… more
- Merck & Co. (North Wales, PA)
- …to be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM ... stakeholders.Position Specific Skills and Experience: Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO,… more
- Daiichi Sankyo, Inc. (Bernards, 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 ... to provide complex data review listings and reports to support Data Management and clinical teams. Develop, implement and maintain SAS programming… more
- Legend Biotech USA, Inc. (Boston, MA)
- …Medical Affairs team. Direct education for healthcare professionals treating oncology patients on clinical data , adverse event management , and mechanism of ... between investigators and members of the Legend Biotech Medical Affairs and Clinical Development teams; Addressing AE management and education as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The PositionThe Novo Nordisk Real World Evidence (RWE) / Clinical Data Science & Evidence (CDSE) - Fellow is responsible for supporting ... 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …business functions include but are not limited to Clinical Operations, Clinical Development, Biostatistics and Data Management , Regulatory Affairs, ... Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management , Quality Assurance, Medical Affairs, Translational Research, Research, Informatics… more
- Genmab (Plainsboro, NJ)
- …is assigned to a trial the GCTM takes on the CTM role too.ResponsibilitiesLead the Clinical Trial Team (CTT) and Trial Management (TM) teamDefine and align CTT ... our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery of a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review Plan ... Organization (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical… more
- Merck & Co. (Rahway, NJ)
- …E2E product development process & connectivity between functions supporting pipeline (ie clinical development, Compound Management Coordination , supply chain, & ... Compound Management Coordination activities.- - Support the collection of clinical supply chain metrics and/or participate in critical non-pipeline activities as… more
- Merck & Co. (North Wales, PA)
- …data collection in alignment with the protocol in collaboration with Data Management /Programming.Collaborating cross-functionally to monitor clinical ... vendors, clinical outcome assessments, biomarker sample collection and management , and external data monitoring committee.Managing other scientists directly… more
- Merck & Co. (Rahway, NJ)
- …and subsequent movement through our depot network and further through to distribution and management of materials to the clinical site. The incumbent must have ... communicate with stakeholders at various levels, including cross-functional teams, senior management , external vendors, and clinical sites. Strong negotiation,… more
- Genmab (Plainsboro, NJ)
- …management , process and continuous improvement management , digital or data technology, operations, supply chain, manufacturing, ERP, clinical supply ... or biopharmaceutical industry.Broad and Diverse experience in working with trial management for global clinical drug supply and supply functionsKnowledge… more
- Daiichi Sankyo, Inc. (Bernards, 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)
- …communicate with stakeholders at various levels, including cross-functional teams, senior management , external vendors, and clinical sites. Strong negotiation, ... business risks, & influence portfolio decisions with facts and data - Demonstrates ability to balance strategy with ability... Skills: strong knowledge of the principles of project management and clinical customer relationship management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operations, oversight of initiatives and trouble-shooting issues. Liaison for CS Physician and Data Management for study related safety reporting. Will also act ... perform final review. This position provides input on electronic data capture (EDC) Safety report outputs, reviews clinical... Data Capture (EDC) Responsibility: In conjunction with Data Management , establish the EDC strategy at… more
- Genmab (Plainsboro, NJ)
- …purpose.Genmab is looking for a dynamic, science-driven people leader to head our Clinical Pharmacology & Quantitative Sciences team. Do you get excited by our well ... innovation powerhouse. The RoleYou will act as functional leader of our Clinical Pharmacology & Quantitative Sciences (CPQS) group, currently consisting of 25+… more
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