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 jposting(at)in.ibm.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 jobs posted by Regeneron

Listing 226 jobs posted within 600 days!

Date Description Location
Supplementary Results
Thursday
Jan-30-2015 Inter-Partition Communications Engineer (m/f)
source:
On behalf of a leading global Telecommunications company, SOLA Consulting GmbH is searching for an I
Bayern, Germany
Jan-30-2015 Senior Router ATE Test Expert (m/f)
source:
On behalf of a leading global Telecommunications company, SOLA Consulting GmbH is searching for a Se
Bayern, Germany
Wednesday
Jan-29-2015 SENIOR TECHNICAL ANALYST, CITRIX
source:
With 47 ports of call, 35 vessels, and more than 500 sailings every day, BC Ferries is the largest i
Victoria, British Columbia (BC), Canada
Jan-29-2015 Scientist III
source:
Alliance Scientific Solutions is recruiting for a Scientist III for a Polymers company in Cleveland
Independence, Ohio, United States
Jan-29-2015 Product Development Engineer, ASME, RND, Job #4339
source:
Product Development Engineer, ASME, RND, Job #4339 - Akron, OH Relocation Available for non-local ca
Akron, Ohio, United States
Jan-29-2015 Real Estate/Finance Paralegal
source:
One of Cleveland's finest law firms is expanding it's real estate practice group and is adding a Rea
Cleveland, Ohio, United States
Jan-29-2015 Social Worker or Counselor/Group Facilitator
source:
Benjamin Rose Institute on Aging, a leader in community services and applied research is seeking a 1
Cleveland, Ohio, United States
Jan-29-2015 Senior Software Developer | Algorithms
source:
Senior Software Developer required with experience of a variety of development languages for example
London, United Kingdom
Jan-29-2015 Business Analyst (Agile)
source:
5-7 years of experience in a similar BA role Third level qualification in a computer science, multi
Dublin, Dublin, Ireland
Jan-29-2015 Customer Care Specialist
source:
Our direct client in Austin, TX has multiple openings for Customer Care Specialists. These are 6 mon
Austin, Texas, United States
Jan-29-2015 Consultant Statistician
source:
Consultant BiostatisticianClient: Global, Leading Pharmaceutical CompanyLocation: Illinois, USARate:
Illinois, United States
Jan-29-2015 Research Scientist - Finite Element Analysis/Computational Fluid Dynam
source:
The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) is looking for
Frederick, Maryland, United States
Jan-29-2015 Assistant Manager, Operations and Classroom Support, University Inform
source:
YORK UNIVERSITY is helping shape the global thinkers who will define tomorrow. Our unwavering commit
Toronto, Ontario (ON), Canada
Jan-29-2015 *Senior Research Analyst - Leading Electronic Trading Platform - Londo
source:
London, United Kingdom
Jan-29-2015 R&D Analyst/Researcher
source:
R&D Analyst/Researcher Tremendous opportunity for a R&D Analyst/Researcher to join an innovative so
Atlanta, Georgia, United States
Jan-29-2015 Senior CEA and Machine Learning Expert
source:
Manning Global, is urgently looking for a Senior CEA and Machine Learning Expert for our client, a p
Luxembourg
Jan-29-2015 Principal Electronics Engineer - Power Supply, Microcontrollers
source:
Principal Electronics Engineer - Power Supply, PSU, Micro-controllers, Boost, Fly-back, Buck convert
Hertfordshire, United Kingdom
Jan-29-2015 Software Development Engineer, Job #4467
source:
Software Development Engineer, Flex/Flash, Java, HTML, Cleveland, Ohio, Job #4467 REQUIREMENTS - Bac
Cleveland, Ohio, United States
Jan-29-2015 MR - Digital Analytics Manager
source:
Position Duties: This challenging position will play a key role in developing high-quality and stra
Atlanta, Georgia, United States
Jan-29-2015 Applications Architect
source:
The Applications Architect for CRM will influence the development and implementation of Information
Atlanta, Georgia, United States