- Novo Nordisk Inc. (WA)
- …proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and ... the application of those principles to trial planning and conduct of clinical trials Demonstrates proficiency with computer skills (MS Office, MS Project, MS… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Action/Preventive Action (CAPA) plans and related effectiveness measures, as appropriate.Responsibilities: Clinical Trial Operational Risk Management :Own, ... (RMPs) (design, management , and maintenance) for global clinical trials .Provide day-to-day support to study teams...a community of practice centered on Quality by Design, Clinical Trial Risk Management , efficient… more
- Merck & Co. (Rahway, NJ)
- …and SAP team members to further extend capabilities and functionalities on our existing Clinical Trial Supply Management (CTSM) solution in order to satisfy ... and Distribution areas with a strong focus in Clinical Trial Supply Management (CTSM)...support of- SAP applications across all functional areas supporting Clinical Trials . This includes leading or contributing… more
- Merck & Co. (North Wales, PA)
- …datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing ... of 9 years Statistical Analysis System (SAS) programming experience in a clinical trial environment. MS (preferred) in Computer Science, Statistics, Applied… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Associate Director, Clinical Data Standards, is responsible for the ... pipeline.Proactively identify Data Standards gaps and resolve issues related to clinical data standards development throughout the trial lifecycle.Standardize… more
- Merck & Co. (Rahway, NJ)
- …a functional and/or line management position.Deep knowledge and understanding of Clinical Trial processes, GCP and applicable clinical research-related ... Job DescriptionIt is critical that, for all company-sponsored clinical trials , patient safety, high quality...- -This includes line management of Country Clinical Quality Managers (CCQMs) and Associate Country… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders.Summary The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions in the West, in ... adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food...primarily a tactical study delivery role, reporting into an Associate Director or above responsible for Operational Study Strategy.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …understanding and execution requiredStrong experience in procedural writing and life cycle management requiredAdditional clinical trial process experience in ... other research areas centered around rare diseases and immune disorders.Summary The Associate Director, Global Clinical Operations (GCO) Procedural Ownership and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and standards. This position ensures quality delivery of medical coding for clinical trials , clinical development, and regulatory submissions. Develops ... strategies for medical coding and coding dictionary ensuring all clinical trials meets quality requirements and best...medical coding expertise to promote best practices across the Clinical Trial lifecycle.Applies GCP principles to ensure… more
- Merck & Co. (Rahway, NJ)
- …translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative ... and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications… more
- Aequor (Thousand Oaks, CA)
- …LIMS (laboratory information management system) and a basic understanding of clinical trials understanding, and a strong understanding of MS Excel.This role ... will assist the biospecimen operations team on the day-to-day monitoring and management of the laboratory information management system (LIMS). This will… more
- Insmed Incorporated (Jacksonville, FL)
- …strong related experience. Other Pharmaceutical experience - Medical Information, Medical Strategy, Clinical management / trial experience and 2 years ... a local medical and scientific resource to Insmed for product planning, clinical insights, and intelligence. Capture, synthesize and deliver HCP derived scientific… more
- Merck & Co. (Rahway, NJ)
- …more novel quantitative approaches that seek to improve cycle time, cost/size, number of trials , clinical trial design and Go/No Go decisionsFraming critical ... (popPK), PK/PD models, exposure response (ER) models, model-based meta-analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into… more
- Merck & Co. (North Wales, PA)
- …is responsible for statistical planning and data analysis of Phase I/II oncology clinical trials as well as translational biomarker analyses. This position ... , and other company Research Laboratories scientists in designing and analyzing data from clinical trials as well as analyzing oncology biomarker and clinical… more
- Catalent (Emeryville, CA)
- …health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion ... Research Associate II, BioconjugationPosition Summary:Catalent Pharma Solutions in Emeryville,...conjugation chemistry and proprietary, stable linkers. SMARTag is a clinical -stage technology that was named Runner Up for Best… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …degree preferred A minimum of ten (10) years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, or CRO required, ... of FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required Demonstrates technical expertise within Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …& category management required- CRO experience preferred- Strong knowledge of clinical trials preferred- Demonstrated ability to leverage digital data and ... categories under the direction of the head of category management , for the creation, execution, tracking of strategies. Includes...or More Years Outsourcing, health sciences or related field ( clinical trials ) required- 7 or More Years… more
