- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 ... Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle… more
- Eisai, Inc (NJ)
- …profile, we want to hear from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and support activities related to the outsourcing ... of clinical services to Clinical Research Organizations (CROs)...including functional services.Accountable for vendor management; providing guidance to study teams on vendor selection and management options in… more
- Eisai, Inc (NJ)
- …within ESI. Continuously update plans and inform stakeholders of progress.Phase IV Clinical Studies : Direct and design strategies, planning and implementation of ... of the pharmaceutical marketplaceFDA regulations/ICH guidelines regarding conduct of clinical studies in relevant therapeutic areaKnowledge of regulatory… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- … Scientist leads in the development, evaluation, planning and execution of clinical studies and ensures integrity and interpretation of study data of a ... necessary to design and deliver on clinical studies and programs. As a Senior Manager...in collaborative activities with other departments; Member of the Clinical Study Team and Global Clinical… more
- Medtronic (North Haven, CT)
- Senior Clinical Research Business Process Improvement...will be a key partner in supporting projects and clinical studies across the operating unit, as ... Manager In this exciting role as Senior Clinical Research Manager in the Surgical...and objectives. + Provides leadership for the conduct of clinical studies and for the regulatory affairs… more
- Alaka'ina Foundation Family of Companies (Frederick, MD)
- …Staff Supervisor; Clinical Study and Volunteer Assistant; Volunteer Recruiter ; Senior Volunteer Recruiter ; Program Manager/ Clinical Portfolio ... Regulatory, Clinical , and Technical Clinical Trial support Location MD - Frederick Job Code 10393 # of openings 1 Apply Now… more
- University of Colorado (Aurora, CO)
- Clinical Research Coordinator (Entry - Senior Level) - 32978 University Staff **Description** **University of Colorado Anschutz Medical Campus** **School of ... Medicine | Department of Psychiatry** **Job Title:** ** Clinical Research Coordinator (Entry - Senior Level)**... trials. + Assist with recruitment and pre-screening of study participants. + Coordinate and run research visits including… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …+ Responsible for the relevance and accuracy of medical science underpinning the clinical study , based on thorough scientific review and consultation with ... Strategy Head for the Program + Designs POC-enabling human studies , First-In-Human (FIH) studies , POC ( clinical...the medical and scientific portions of protocol synopsis and clinical study protocols and amendments; Reviews and… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …+ Responsible for the relevance and accuracy of medical science underpinning of clinical study concepts (CSC) based on thorough scientific review and ... The Senior Medical Director, Immunology & Inflammation, will provide... Medical Director, Immunology & Inflammation, will provide overall clinical scientific leadership for Regeneron's Immunology & Inflammation programs… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- … data prior to submission to regulatory authorities (eg, protocols, investigator brochures, clinical study reports). + Manages clinical timelines, budgets, ... clinical feasibility assessment and strategic planning of clinical trial programs or studies . Executes on...boards/ethics committees. + Escalates significant issues on program(s) and study (ies) to senior management in a timely… more
- Kelly Services (Frederick, MD)
- … clinical and nonclinical toxicology studies . + Proficient in clinical research and toxicology study protocol development. + Experience with biologics ... in the world. We are currently seeking a Toxicology Senior Scientist with the National Institutes of Health in...Affairs. + Attend and contribute to team meetings discussing clinical and nonclinical toxicity studies . + Prepare… more
- Mayo Clinic (Jacksonville, FL)
- …well as monitor the progress for some well-defined biostatistical aspects of research and clinical studies . The Senior Biostatistician will delegate tasks to ... expertise to the design, implementation, analysis, interpretation, and reporting of research, clinical and administrative studies . The Senior Biostatistician… more
- ThermoFisher Scientific (Wilmington, NC)
- …cost) on behalf of the organization. This individual manages all aspects of assigned clinical trials as well as the study project plan, including timeline, ... step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel… more
- Medtronic (Mounds View, MN)
- …research studies that provide value, perspective and evidence for clinical and/or pre- clinical product portfolio decisions, marketing, regulatory agency ... the clinical , economic, and quality of life outcomes data from clinical trials and/or epidemiology studies , registries, observational studies , modeling,… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …publications group to ensure production of abstracts, posters, and manuscripts from conducted studies * The Senior Manager of Global HEOR will design, develop, ... these positions will provide epidemiological, statistical and analytical support for all studies involving the HEOR department as well as assist in the development… more
- Randstad US (Deerfield, IL)
- …Masters responsibilities: + Author and/or provide input on statistical sections of clinical study documents including protocols, electronic case report forms, ... statistical analysis plans, tables, listings, and figures (TLF) shells, SDTM/ADaM specifications, clinical study reports, and other relevant documents. + Drive… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …the time of Protocol development predicated on ICH E6 R2. + Partnering with Clinical Study Lead/Oversight Monitoring and CRO to provide oversight to site level ... The Senior Manager, Global Development Quality Management (GCP) acting...have experience:** + Leading Quality Risk Management activities on clinical trials within assigned studies and Control… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …implement specific biomarker and exploratory sample collection and analyses in all relevant clinical studies in selected programs + Design, oversee and manage ... highly matrixed role, they will design, develop, communicate at senior levels and operationally implement clinical biomarker...and ensure the quality of Precision Medicine technical reports, study memos and clinical study … more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- As a Senior Director you will be responsible for leading HEOR-Epidemiology activities to inform, support, and strengthen global development and commercialization ... oncology therapeutic area. Drawing on your expertise in epidemiologic study design and methods as well as on your...will design, conduct, and reporting of real-world evidence (RWE) studies . It is expected to have current epidemiologic methods… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …project leadership and contributes to the programming support for processing data from clinical studies . Project requirements will be identified according to a ... The Senior Manager provides timely support to the team...Regeneron standard data models and/o integration of data across studies in support of CSS/CSE and esub deliverables. +… more
