- Merck & Co. (Rahway, NJ)
- …vendor assay statement of work and data transfer specifications to the clinical teams. Work with data management to effectively transfer biomarker ... the Integrated Biomarker Operations organization to provide biomarker project management and operational expertise to support cross-functional clinical... data to clinical data repository from external biomarker vendors.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … clinical trial diversity to drive informed decision-making with management Experience in ICH-GCP principles, regulatory requirements, and compliance requirements ... 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. (Rahway, NJ)
- …vendor assay statement of work and data transfer specifications to the clinical teamsWork with data management to effectively transfer biomarker ... the Integrated Biomarker Operations organization to provide biomarker project management and operational expertise to support cross-functional clinical...data to clinical data repository from external biomarker vendorsWork… 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 ... communication between CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL… more
- Merck & Co. (Rahway, NJ)
- …related drug/vaccine projects in Late Development Statistics.Lead the interaction with Clinical , Regulatory, Statistical Programming, Data Management , and ... Job DescriptionPosition Description: Senior Principal Scientist, Biostatistics (Hybrid) In BARDS (Biostatistics...design and analysis of clinical trialsStrong project management skills. --Solid knowledge of-statistical and data … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review- Conducts clinical data review per Integrated Data Review Plan- Accountable ... areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical ...Monitor (MM):- Provides oversight to the CRO MM for clinical data review activities- May support addressing… 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 PlanAccountable for ... Organization (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical… more
- Genmab (Plainsboro, NJ)
- …As part of our expanding US Medical Affairs (USMA) team, Genmab is seeking a Senior Director, USMA Solid Tumor Portfolio. This role will report to the VP/Head of US ... solid tumor therapies and relevant studiesProvides US market input to Global clinical development and Global Medical Affairs programs, staying abreast of the… more
- Eisai, Inc (VT)
- …knowledge and participate in scientific exchanges and interactions with identified KOLs.Present clinical , scientific and economic data on Eisai's products and ... you. Job Summary The Medical Science Liaison (MSL) / Senior Medical Science Liaison (Sr.MSL) is a field-facing representative...all MSL activities, as required and assigned by the management .Identify and report key scientific, clinical and… more
- Merck & Co. (North Wales, PA)
- …plans which describe the methodology to be programmed; applying statistical terminology and clinical data management concepts; CDISC and ADaM standards; ... clinical studies using deep scientific knowledge, statistical analysis and high-quality data to support decision making in clinical trials.Support statistical… more
