- Merck & Co. (Rahway, NJ)
- …(Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed Oncology medicines. ... clinical development strategies for investigational or marketed Oncology drugsPlanning clinical trials (design, operational plans, settings) based on these … more
- Merck & Co. (Rahway, NJ)
- …monitoring in our clinical trials . Under the oversight of the Clinical Research Director (CRD) or Head of Site Management and Monitoring, the person ... to manage a team of 6-14 Clinical Research Associates (CRAs) and to ensure excellent study...trial execution.Escalates site performance issues to CRM and Clinical Research Director CRD.People and Resource Management:Manage… more
- Merck & Co. (North Wales, PA)
- …(Principal Scientist) has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. Our ... clinical development strategies for investigational or marketed Oncology drugs;Planning clinical trials (design, operational plans, settings) based on these … more
- Novo Nordisk Inc. (WA)
- …North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local ... for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research ...principles to trial planning and conduct of clinical trials Demonstrates proficiency with computer skills… more
- Merck & Co. (Rahway, NJ)
- …for the execution of the Merck clinical research portfolio. The Clinical Sciences & Study Management Department of the GCTO organization focuses on the ... trials . You will assist the Lead Clinical Scientist and study team with the scientific conduct of clinical studies . In this position, you will have… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …appropriate Leads the data acquisition that study teams will utilize to develop study specific clinical trial diversity plans Leads the strategy of ... barriers to diverse participation in DS clinical trials - Clinical Trial Design-...leads in the establishment of a Clinical Trial Diversity template to be followed by study… more
- Merck & Co. (Rahway, NJ)
- …in 47 countries, responsible and accountable for the execution of the Merck clinical research portfolio. The Global Clinical Operations (GDO) department ... collection, data review and integrity throughout the lifecycle of clinical trials .- Clinical trials ...study sites, vendors, committees, etc.) in support of clinical study objectives.--You will be part of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … levels, taking into consideration the epidemiology of the disease -Review applicable study specific clinical trial materials to ensure cultural sensitivity ... and Infrastructure.Build processes withing GCO to achieve diversity in clinical trials and patient focused drug development...health literacy guidelines are followed.Establish tracking mechanisms at the study team and clinical trial … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …develop/provide input into metrics to help track and oversee the progress of clinical trial risks at both a study and aggregate level to monitor and evaluate ... areas centered around rare diseases and immune disorders. Summary The Director, Global Clinical Operations (GCO) Clinical Trial Operational Risk & Oversight… 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, ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic...to the study and propose mitigation plans.Monitor study budget against trial progress and bring… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monitor for one or more studies , as neededCollaborates with assigned Clinical Research Organization (CRO) and/or Medical Writer to contribute to drafting ... for multiple, concurrent programs spanning all phases (I-IV)) of clinical research . The incumbent is responsible for...key study documents and medical oversight of clinical study conduct; Collaborates closely with internal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the Study ... on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study...include preparing meeting logistics, distributing agendas, and minutes for study team meeting, meetings with Academic Research … more
- Merck & Co. (Rahway, NJ)
- …for the execution of the Merck clinical research portfolio. The Clinical Sciences & Study Management Department of the GCTO organization focuses on the ... for a single study or across multiple studies (eg, operational deliverables, clinical & ancillary... study team, vendors, committees) in support of clinical trial objectives. You will be part… more
- Merck & Co. (North Wales, PA)
- …and external stakeholders (eg, study team, vendors, committees) in support of clinical trial objectives.Core Skills Working knowledge of clinical ... the operational planning and execution of one or more clinical trials . In this position, you will...for a single study or across multiple studies (eg, operational deliverables, clinical & ancillary… more
- Merck & Co. (North Wales, PA)
- …(Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new Oncology medicines within an Asset ... clinical development strategies for investigational or marketed Oncology drugs-Planning clinical trials (design, operational plans, settings) based on these … more
- Merck & Co. (North Wales, PA)
- …is a key collaborator with internal and external stakeholders including Statistics, Clinical Research , Regulatory, Observational Research , Clinical ... :Address operational challenges that require strategic solutions, resulting in improved Clinical Study Report and filing completion timelines worldwide.Lead… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …4+ years Pharmaceutical/Biotech industry experience, including time managing clinical trials , or academic clinical research background Working knowledge ... functional teams to support the design and execution of clinical trials , the drafting of medical/ scientific...clinical and scientific expertise to the design of studies , writing of protocols and other study … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to trial outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for investigator-sponsored studies (ISS) and provide comments ... DO required A minimum of 5 years of combined clinical , research or Pharma experience required Experience...trials and with other MA tools (expertise in clinical trial methodology and conduct, GCP principles,… more
- Taiho Oncology (New York, NY)
- …care practitioners on Taiho products and relevant disease states, and facilitation of clinical research . The Sr. MSL integrates clinical and scientific ... SLs, HCPs, and institutions in geography to be covered is preferred. Clinical trial development experience is preferred. Knowledge of treatment guidelines,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to support clinical trials and regulatory submissions, which may include: Clinical study protocols and protocol amendments Clinical study reports ... (IB) Informed consent and assent forms Lay summaries of clinical trial results Clinical evaluation...mastery of English grammar and punctuation Demonstrated understanding of clinical research principles and the drug/device development… more
