- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders.Summary This position supports the strategy for driving global Clinical Study Start -Up activities for PV Safety Operations. ... clinical study safety reporting and activities.Global Clinical Study Start -Up Documentation: Reviews... protocols to ensure consistency in safety requirements across studies related to a similar compound. Develops and maintains… 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 ... goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile the TMF document… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …resolve or escalate to appropriate Governance Committee. Analyze CRO performance trends within a clinical study or across several studies and resolve or ... clin pharm patient studies , and Phases 1-3 clinical trials at the study and program...for clinical program planning and execution (from study design, operational planning, start -up, conduct, reporting,… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThis position drives scientific planning, strategy and execution of Phase 1-4 clinical studies .-Under the direction of the Program Lead, you will ... collaborate with global, cross- functional team-members including clinical directors and study managers to... deliverables.Participates in the set up and design during study start up (eg, database set up)Lead… more
- Insmed Incorporated (Bridgewater, NJ)
- …operational support for the Clinical Operations team with heavy focus on study start ‐up activities, patient recruitment efforts, maintenance, and study ... Operations objectives by providing operational support to the clinical study team (CST) with the responsibility...understanding of the DIA TMF Reference Strong familiarity with study start ‐up activities, including feasibility, country and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for DS Programs / Studies .Serve as the subject matter expert for Study Data Managers during the planning/ start -up, conduct and close-out of external data ... end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and accountable for tasks, processes and deliverables from trial start up through closure, including but not limited to:… more
- Daiichi Sankyo, Inc. (Munich, ND)
- …and annual meetings with the DS FIH Site Network to ensure agile study start -up/MSAs in place, enrollment target needs, etc.Responsible for executing and ... portfolio at the sites. Such measurements will be reviewed both per site running multiple studies , and per study at multiple sites. These metrics include time to… more
- Merck & Co. (Rahway, NJ)
- …a Clinical Data Manager (CDM).Responsible for all protocol level start -up, in-life and database lock tasks and activities.Interact and communicate with customers ... Job DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Summary Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the Study ... and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).ResponsibilitiesReconcile the TMF document trackers… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and ... delivery of all 3rd party data from diverse external providers for clinical trials, companion diagnostics trials, clinical development, and regulatory… more
- George Washington University (Washington, DC)
- … Trials Management System (CTMS). Acts as a communication liaison between GW OCR, clinical study staff, and internal and external customers during the ... clinical trial start up process. Provides functional...across Phases II-IV and ICH GCP Good understanding of clinical research trial protocols, associated study specifications,… more
- Russell Tobin & Associates (San Diego, CA)
- …point of accountability for all stages of clinical operations activities (early study design, start -up, active study , and close-out) Collaborate with ... in medical device, pharma, IVD and/or CRO 5-8 years experience leading clinical study preparation and monitoring and leading study team Proven track… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …Lovelace Biomedical and its Commercial Clients throughout the prospecting, award, and study closure stages. The position will be responsible for overseeing the life ... cycle of a scientific program with the Scientific Operations staff from start to finish driven by a clear understanding of both Client and CRO needs and… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …has expanded our academic prowess and the potential to conduct innovative clinical trials to impact respiratory diseases. While NYMC's primary mission is training ... research on the prevention, treatment, and cure of respiratory disease. LBRI studies respiratory health issues of concern to scientists and health care experts… more
- George Washington University (Rockville, MD)
- …Center serves as the data coordinating center for large scale multi-center clinical trials and epidemiologic studies funded by the National Institutes ... position the Research Assistant will work on NIH funded clinical research studies conducted by the Eunice...review of SAS logs and output.-Monitors compliance with research study protocol.-Maintains tracking of clinical site staff… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …the study implementation process. Study Initiation: Plan, organize, implement clinical trials/research studies to effectively meet goals and ensure timely ... clinical researchEssential Tasks and ResponsibilitiesRecruits and screens potential study participants.Develops and conducts patient and family education regarding… more
- George Washington University (Washington, DC)
- …NIH-funded prospective multi-site longitudinal cohort study , the DC Cohort. This study captures clinical information on persons with HIV receiving outpatient ... HIV care in Washington, DC, at 14 clinical sites and has been operating since 2009 in...as necessary. This person will collaborate directly with the Study Principal Investigator, Co-Investigators, and clinicians at participating sites… more
- George Washington University (Rockville, MD)
- …Center serves as the coordinating center for large scale federally funded multi-center clinical trials and epidemiological studies . The Biostatistics Center is a ... research team serving as the Coordinating Center for Diabetes Prevention Program Outcomes Study . Position will serve as a Data Engineer and Scientist role and leads… more
- George Washington University (Washington, DC)
- …suppression among a cohort of persons living with HIV and receiving care at 12 clinical sites in Washington, DC. The study will be conducted in partnership with ... office environment but travel to clinics that participate in the DC Cohort study is required. Preferred Qualifications: Knowledge of clinical aspects of HIV… more
