- Eisai, Inc (Nutley, NJ)
- …Travel (approximately 25%)Eisai Salary Transparency Language:The base salary range for the Associate Director, Clinical Quality Assurance is from ... regulations for those undertaking clinical studies.Job SummaryThe Associate Director, GCP Quality Assurance works within...the conduct of clinical trials Knowledge of data integrity controls and systems quality for… more
- Merck & Co. (Rahway, NJ)
- … Practice (GCP) studies, and occasionally Good Laboratory Practice (GLP) studies.The Associate Principal Scientist is the primary clinical study team leader ... Job DescriptionJOB DESCRIPTION SUMMARYThe Associate Principal Scientist is a DVM/VMD and/or PhD...Respect - Inclusion.Design and organization of paper and Electronic Data Capture (EDC) clinical studies that meet… more
- Merck & Co. (Rahway, NJ)
- …key partner organizations (as a lead GCS Planning program representative) such as clinical development, regulatory, quality and other supply chain areas to ... Business, Business Risks, Change Management, Clinical Development, Clinical Research, Cross-Functional Team Leadership, Data Analysis, Detail-Oriented,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...& Data Ops for EDC, edit checks, data quality listings, SAP, Data … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technology, and standards. This position ensures quality delivery of laboratory data for clinical trials, clinical development, and regulatory ... centered around rare diseases and immune disorders. Summary: The Associate Director, Laboratory Data Management is accountable...proposes strategies for laboratory data ensuring all clinical trials meets quality requirements and best… more
- Eisai, Inc (Exton, PA)
- … Quality Control, Regulatory, and CMC Program Management departments.The Associate Director of Biologics Operations maintains knowledge of established and ... is your profile, we want to hear from you.The Associate Director of Biologics Operations Upstream and Downstream is...in development through their lifecycle (Preclinical through phase III clinical development) at the Biologics Pilot Plant as well… more
- Merck & Co. (North Wales, PA)
- …be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM ... Specific Required Skills and Experience: Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH;… more
- Merck & Co. (North Wales, PA)
- …and programming requests in close collaboration with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data , transform the ... ADaM standards is also required.Must possess significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …dataset in compliance with CDISC and submission requirement, review study submission data package and ensure its quality and integrity.- Provide hands-on ... template on datasets and TFLs to improve efficiency and quality . Responsibilities include: contribute to CRF and SDTM standard...effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis- Develop and maintain… more
- Merck & Co. (Rahway, NJ)
- …techniques.Background in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis ... of our Research & Development Division is seeking applicants for an Associate Principal Scientist position available at its Rahway, New Jersey research facility.-… more
