- 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)
- …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
- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… 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
- 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
- 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
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you.The Associate Director supports the Eisai Global Oncology Business Unit for the Americas, EMEA, ... Senior Leaders to drive program plans and decision making Job Summary The Associate Director supports the Eisai Global Oncology Business Unit for the Americas, EMEA,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …statistical activities; collaborates closely with data manager to ensure high quality data .Drug Development Strategy: Provides input to multiple aspects of ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies… more
- Novo Nordisk Inc. (Durham, NC)
- …our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate ... QC - OFP. Essential Functions Accuracy & Scientific Soundness of Lab Data Environmental Compliance GMP Compliance of Laboratory Maintain testing proficiency for… more
- Merck & Co. (Rahway, NJ)
- …evaluations, and regulatory filings.Design, plan, and execute laboratory experiments to generate high quality data .- Perform data analysis and ensure results ... Automation, Safety, Technical Services, Process Development, Analytical, Regulatory, and Quality .As part of Our Company's Manufacturing Division, within the… more
- Merck & Co. (Rahway, NJ)
- …Skills:Adaptability, Adaptability, Analytical Chemistry, Branding, Brand Management, Clinical Data Interpretation, Communication, Corporate Branding, ... a variety of opportunities for cross departmental collaboration (eg Finance, Quality , Procurement) across the development areas collaborating with various chiefs of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …respective cross functional groups, CROs, Affiliates in order to ensure high data quality and proactive detection and resolution of issues.External ... diseases and immune disorders. JOB SUMMARYThe Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to drive the implementation… more
- ICON Clinical Research (San Antonio, TX)
- Clinical Data Quality Associate - Early Phase Clinical Research- ICON San Antonio TX ICON plc is a world-leading healthcare intelligence and ... to shape the future of clinical development. We are currently seeking a Clinical Data Quality Associate to join our diverse and dynamic team. As… more
- Blue Cross Blue Shield of Massachusetts (Boston, MA)
- …Collaborate with external vendors, providers, and partners to ensure the delivery of high- quality clinical data . + Lead implementation of technology ... your true colors to blue. What we need The Associate Director of Clinical Data ...function, providing strategic direction, and ensuring the delivery of high- quality , trustable clinical data to… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** Associate Director, Principal Clinical Data Engineer at Boehringer Ingelheim Pharmaceuticals, Inc. in Ridgefield, CT (Telecommuting ... data from internal and external sources. Ensure Data Quality and Integrity by implementing plausibility...and maintain ongoing project / TA level operations of clinical data environments, and respond to project… more
