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 488 jobs posted within 1600 days!

Date Description Location
Supplementary Results
Tuesday
Apr-26-2017 Retail or Customer Service experience? Start ASAP
source:
City, Birmingham, United Kingdom
Apr-26-2017 Retail or Customer Service experience? Immediate start required
source:
Do you have Retail or Customer Service experience? Our client, HOME Fundraising are on the lookout f
City, Bristol, United Kingdom
Apr-26-2017 Retail or Sales Assistants (Change your career to sales today)
source:
Are you a retail or sales assistant who would like to get more out of your job? How about getting pa
City, Dundee, United Kingdom
Apr-26-2017
source:
Dunstable, Bedfordshire, United Kingdom
Apr-26-2017 C#.Net Developer - Sheffield
source:
C#.Net Developer - Sheffield - YorkshireRoc Search are currently recruiting for a Senior Developer t
Sheffield, Yorkshire, United Kingdom
Apr-26-2017 Senior UX Designer
source:
Dunstable, Bedfordshire, United Kingdom
Apr-26-2017 Researcher - Machine Learning, Computer Vision, PhD
source:
Amazing computer vision company whose product has been developed with machine learning and computer
Manchester, Lancashire, United Kingdom
Apr-26-2017 Python Developer Software Trading Asset Management London
source:
Python Developer (Software Engineer Programmer Python Developer SQL NoSQL JavaScript AngularJS Finan
London, United Kingdom
Apr-26-2017 Research Manager - Computer Vision, 3D Modelling, Machine Learning
source:
Machine Learning company with focus in Computer Vision require a Research Manager - Computer Vision,
Manchester, Lancashire, United Kingdom
Apr-26-2017 Full-Stack Developer - Permanent - Banking - Emerging Tech/Innovation,
source:
Full-Stack Developer - Permanent - Banking - Emerging Tech/Innovation, JEE - London Key Skills: Jav
London, United Kingdom
Apr-26-2017 Maritime Hardware Design Engineer
source:
Job Role: Maritime Hardware Design EngineerLocation: Hampshire Type: Contract Duration: 3 months Ini
Hampshire, United Kingdom
Apr-26-2017 Django Developer
source:
Python/Django role based in Central London! Their platform is specialised for open access academic p
London, United Kingdom
Apr-26-2017
source:
Lead .NET Developer - Portsmouth- C#, ASP.NET, MVC 3/4 - Agile, TDD, Continuous Integration, Depende
Portsmouth, Hampshire, United Kingdom
Apr-26-2017 Lead Python Developer
source:
Python/Django role based in Central London! Their platform is specialised for open access academic p
London, United Kingdom
Apr-26-2017 Tax Senior Associate
source:
Provide compliance and consulting services in all aspects offederal, state, local and international
Englewood, Colorado, United States
Apr-26-2017 Call Center/Customer Service Representative - Akron, OH
source:
Call Center/Customer Service Representative - Akron, OH As a leading provider of call center solutio
Akron, Ohio, United States
Apr-26-2017 Windows/Virtualization Engineer
source:
Systems Engineer with Virtualization and some networking This company has 65 users, 3 locations (Sko
Skokie, Illinois, United States
Apr-26-2017 IT Security Analyst
source:
Prestigious Organization is seeking an IT Security Analyst. Looking for someone with 2-4 years of ex
Chicago, Illinois, United States
Apr-26-2017 Director of Product Development, Healthcare Insurance Products
source:
Prestigious Financial Services Organization is seeking their Director of Product Development, Health
Charlotte, North Carolina, United States
Apr-26-2017 Senior Software Engineer - Machine Learning
source:
Senior Software Engineer - Machine Learning Northbrook, IL Prestigious Fortune 500 Company is in nee
Northbrook, Illinois, United States