- Genmab (NJ)
- …Director, Data Management is operationally responsible for the oversight of Clinical Data Management activities related to the effective planning, and timely ... excellence.Responsibilities:Contributes to and implements the strategic direction of the Clinical Data Management functional areaContributes to the overall… 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)
- …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)
- …education and or training in medical, marketing, and/or communication. An ability to analyze clinical data and synthesize medical evidence into a plan is a ... experienced GTOS by demonstrating, on-the-job, the evidence based approach to clinical trial planning. Provides training, mentorship and instructions on GTO methods… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …participate in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review ... (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical questions… more
- Insmed Incorporated (San Diego, CA)
- …from study design planning through final reporting of results Provide scientific input and review of clinical study data , support in assessing medical ... report development, and database lock processesParticipate in activities related to data review , database lock, medical monitoring, and query resolutionWork… more
- Insmed Incorporated (San Diego, CA)
- …including monitoring of clinical studies, review & interpretation of clinical trial data , authoring clinical study and regulatory communications and ... for all issues identified which may affect the quality and integrity of clinical studies.Medical monitoring, coding, and data cleaning in collaboration with … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …provide complex data review listings and reports to support Data Management and clinical teams. Develop, implement and maintain SAS programming standards ... clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously....database structures.Develop reports & graphs in Spotfire for easier data review and visualization. This includes developing… more
- Merck & Co. (Rahway, NJ)
- …molecules, biologics, and vaccinesBroad understanding of drug discovery, development and research, clinical data coding and experience working within a regulated ... reference and nomenclature data into a centralized databasePerforming data integrity review activities, including proofreadingDeveloping rules to ensure… more
- Merck & Co. (Rahway, NJ)
- …which describe the methodology to be programmed; applying statistical terminology and clinical data management concepts; CDISC SDTM and ADaM standards; ensuring ... potential medical breakthroughs.Support statistical programming activities for Early Oncology clinical development projects. Review the quality and reliability of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …- Certified MedDRA Coder (CMC) or equivalent preferred Experience:4+ years of clinical data management medical coding experience in a medical device, ... documentation. Produces coding reports for periodic predefined study team review . Compiles feedback provided and issues queries and actions...MedDRA, and WHO not DD is requiredWorking knowledge of Clinical trial data systems and/or EDC coding… more
- Taiho Oncology (Philadelphia, PA)
- …trials as assigned, which may include providing recommendations for site selection, clinical data presentation at site initiation or training meetings, and ... and participate in scientific exchanges and interactions with identified KOLs Present clinical and scientific data on Taiho's products and relevant therapeutic… more
- Genmab (Plainsboro, NJ)
- …in the conduct of clinical trials in oncology. Proficiency in clinical data review and interpretation.Solid experience in translating medical/ ... market through collaboration with US Commercialization, Global Medical Affairs, Clinical Development, Regulatory, and other cross functional teams.We have a… more
- Genmab (NJ)
- …reports, as applicable Perform exploratory analysis, ad hoc analyses, and modelling of data Review and approve randomization and stratification plans Perform UAT ... synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reportsCoordinate data transfers from/to business partners… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Job Summary: The incumbent will be responsible for ensuring execution of clinical studies across geographic regions, in adherence to Good Clinical ... operational planning and execution at the study level with responsibility for clinical study plan and execution (from planning start-up, conduct, reporting and close… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and may perform final review . This position provides input on electronic data capture (EDC) Safety report outputs, reviews clinical study and post-marketing ... rare diseases and immune disorders. Summary This position works with the Director, Clinical Study Startup to establish the strategy driving global Clinical Study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategically and scientifically at the study team level including recommendations for and review of data outputs for collection of specific data , ... is a key role responsible for producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. This position… more
- Merck & Co. (Lower Gwynedd, PA)
- …develop and implement automation workflows and tools to increase the efficiency of processes, data review , and data visualization in support of our Vaccines ... new LIMS systems, and develop visualization tools for the review of experimental data and for IT...sound scientific understanding of QbD/DOE principles as well as data analysis and statistics for reporting clinical … more
- Novo Nordisk Inc. (West Hollywood, CA)
- …assess, create and maintain advocacy of customers aligned to company, brand and clinical goals. The OCS develops local strategies and executes local tactical plans ... partners. The OCS also assists their customers with their local clinical and educational initiatives by coordinating company resources (eg, counterparts, materials,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study/CRO plans across the portfolio.Ensure study-specific monitoring plans meet the above standards. Review quality oversight plans that CRO CRAs have in place to ... plan for on-site and remote site visits (expectations of staff contact, ISF review , IP review , SDV/SDR, etc.)Establish and lead the Sponsor Oversight Visit… more
