Jobs -> Regeneron

Business Name Regeneron Your Business Type Private Organization

Contact Details Contact Name Salvatore Bartolone Website URL https://sh.webhire.com/servlet/av/jd?ai= 874&ji=2543481&sn=I Email job.postingskenexa.com Office Address City / Town Tarrytown Province/ State New York ZIP / Post Code 10591 Country United States About About Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST (rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has evaluated therapeutic candidates in Phase 3 clinical trials for the potential treatment of gout, diseases of the eye (wet age-related macular degeneration and central retinal vein occlusion), and certain cancers. Additional therapeutic candidates are in earlier stage development programs in rheumatoid arthritis and other inflammatory conditions, pain, cholesterol reduction, allergic and immune conditions, and cancer. Job Description: The Senior Manager, Clinical Trial Management maintains accountability for the day-to-day operations of 1-4 clinical trials commensurate with complexity, including trial start-up, conduct, and close-out activities. This includes management of an internal functional team that supports an outsource model. Essential Duties and Responsibilities include, but are not limited to the following: Serves as primary contact for functional area representatives in managing all aspects of protocol execution. Interacts regularly with CR0, central laboratory, and IVRS systems; manages scope of work and study progress. Follows established clinical study standards and procedures to plan and conduct clinical research studies. Develops procedures and tools for data collection as needed. Applies knowledge of company policies and standard practices to resolve problems. Analyzes issues and uses judgment to make decisions. Escalates non-standard problems or issues as may be required. Compiles and maintains regular status reports of study progress and study specific timelines and ensures information is provided to Clinical Trial Program Manager (CTPM). Develops study documents including protocols, informed consent forms, and procedure manuals. Maintains open communication channels with study sites and members of the study team. May provide guidance and serve as lead to junior CTMs or other clinical team members. Responsibilities: Manage protocol execution Follows established clinical study standards and procedures to plan and conduct clinical research studies. Assists with, and/or may play a lead role in development of procedures and tools for data collection. Applies knowledge of company policies and standard practices to resolve problems. Analyzes issues and uses judgment to make decisions. Escalates non-standard problems or issues as may be required. Compiles and maintains regular status reports of study progress and study specific timelines and ensures information is provided to Clinical Study Team Leader (CSTL). Plays a lead role in development of study documents including protocols, informed consent forms, and procedure manuals. Executes first line of management for budgets, contracts and resources for a given clinical trial. Coordinates cross functional activities geared to study specific milestones commensurate with experience. Maintains open communication channels with study sites and members of the study team. Provides guidance to other CTMs within project. May travel approximately 25% for the following: including but not limited to investigator meetings, study sites and conferences Experience: A Bachelor's degree from an accredited college or university plus two to five years of relevant Clinical Research experience. Must have managed a clinical study. Work/therapeutic expertise with knowledge of clinical drug development process in biotechnology or pharmaceutical industry required. Knowledge of GCP and ICH and US FDA regulations is a must Ability to develop and manage clinical program budget Proven management skills for CROs and Vendors Broad knowledge and cross-functional understanding of clinical trial methodology. Experience in Dermatology/Asthma desired Apply online at: https://sh.webhire.com/servlet/av/jd?ai=87 4&ji=2543481&sn=I

Listing 371 jobs posted within 600 days!

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Date	Description	Location
Wednesday
Feb-15-2012	Staff Quality Assurance Scientist Posted By: Beckman Coulter Category: Full-time Job Description: This Staff Quality Assurance Scientist is part of the Development Quality Team and is responsible for design control and risk manage...	Brea, California
1 week ago, Monday
Feb-13-2012	Staff Scientist Formulations Posted By: Kenexa Category: Full-time Job Description: We are seeking a Scientist/Staff Scientist in Protein Formulation Development, to participate in the development of stable protein f...	Tarrytown, NY, United States
Feb-13-2012	Research Associate - Protein Formulations Posted By: Regeneron Category: Full-time Job Description: We are looking for a Research Associates in the Protein Formulation Development group, to participate in the development of both liq...	Tarrytown, NY, United States
Feb-13-2012	Global Quality Auditing and Compliance Consultant Posted By: Eli Lilly Category: Full-time Job Description: The Associate Quality Consultant role is part of the Global Quality Auditing and Compliance (GQAAC) division and represents the Corp...	Indianapolis, IN
1 week ago, Friday
Feb-10-2012	SENIOR STAFF TECHNICAL OPERATIONS ENGINEER Posted By: Beckman Coulter Category: Full-time General: ·   Works within the Beckman Coulter Diagnostics business, directly supporting the Immunoassay product line plastic consumables. ·   Report...	Chaska MN
Feb-10-2012	Software Development Engineer Posted By: Beckman Coulter Category: Full-time The Associate Software Development Engineer implements software modules to meet requirements specifications. The incumbent participates in module desi...	Indianapolis, Indiana
Feb-10-2012	Associate Principal User Experience Designer/ Industrial Design Posted By: Kenexa Category: Full-time Job Description: We have embarked on a multi-year plan to build world class design competencies from scratch and we are seeking a passionate and crea...	Cortland, NY
Feb-10-2012	Associate Director, Clinical Trial Management Posted By: Regeneron Category: Full-time Job Description: Oversee and manage all activities related to the conduct of clinical research projects in order to meet deliverables and program obj...	Tarrytown, NY, United States
2 weeks ago, Friday
Feb-03-2012	Assay Development Associate II-IV Posted By: Regeneron Category: Full-time Regeneron is looking for a talented and motivated Assay Development Associate to join our Assay Development Group, reporting to a Scientist in Assay D...	Tarrytown, New York, 10591
3 weeks ago, Wednesday
Feb-01-2012	Neuroscience Specialist Posted By: Kenexa Category: Full-time General Job Responsibilities: ·         The general job responsibilities assigned to the Neuroscience Representative are as follows: ·         Achi...	Princeton, NJ
Feb-01-2012	Scientist Oncology Posted By: Regeneron Category: Full-time Job Description: As a key member of the Oncology team this scientist will be responsible for independently leading and/or contributing to studies in ...	Tarrytown, NY, United States
Jan-25-2012	Senior Customer Technical Specialist Posted By: Beckman Coulter Category: Full-time Range of Responsibility: This Call Center is a 7/24 hour operation. Responds to customer calls, assessing a customer’s requirements and determining t...	Brea CA
Jan-24-2012	Sr. Systems Engineer Posted By: Beckman Coulter Category: Full-time Job description: The Senior Systems Engineer leads a variety of DxN Systems Engineering projects with an emphasis on servicing and troubleshooting Dx...	Danvers, MA
Jan-24-2012	Staff Electronic Engineer Posted By: Beckman Coulter Category: Full-time Job description: The Staff Electronic Engineer provides technical engineering leadership of electronic systems during the investigation, definition, ...	Miami, FL
Jan-24-2012	Field Service Coordinator Posted By: Beckman Coulter Category: Full-time Job Description: The Field Service organization ensures that critical equipment in hospitals, doctor´s offices and research institutes across the cou...	Indianapolis, Indiana
Jan-19-2012	STAFF APPLICATIONS ARCHITECT Posted By: Beckman Coulter Category: Full-time Job Description: The Staff Applications Architect provides technical expertise on one or more applications/or development tools and serves as a techn...	Brea CA
Dec-16-2011	Project Toxicologist Posted By: Regeneron Category: Full-time Job Description: Regeneron is currently seeking a talented and motivated Project Toxicologist to join our preclinical development team, reporting to ...	Tarrytown, New York, 10591
Dec-07-2011	Automation Associate II Posted By: Regeneron Category: Full-time Job Description: We are looking for an Automation Associate II in our Bioanalytical Sciences group. Automation Associates (AA) at this level execute ...	Tarrytown, New York, 10591
Dec-07-2011	Associate Medical Director, Ophthalmology Medical Affairs Posted By: Regeneron Category: Full-time Job Description: Provide strategic scientific and medical support for the Eylea franchise by assuming key roles in medical affairs functions, which i...	Tarrytown, New York, 10591
Dec-07-2011	Scientist, Preclinical Pharmacokinetics Posted By: Regeneron Category: Full-time Job Description: The Scientist Preclinical Pharmacokinetics will serve as a key contributor in the Preclinical Pharmacokinetics Group, providing phar...	Tarrytown, New York, 10591

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