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 365 jobs posted within 600 days!

Date Description Location
Supplementary Results
Wednesday
Dec-18-2014 Senior Business Analyst - Data Governance - Collibra
source:
Data Governance - Business Analyst - Collibra - Metadata - Data Quality - Investment Banking - SQL.
City, London, United Kingdom
Dec-18-2014 Mid Level Infrastructure Engineer/XenApp/Windows
source:
Industry-leading, fast growing company has an immediate need for a Infrastructure Engineer on a dire
Alpharetta, Georgia, United States
Dec-18-2014 Web Builder
source:
CTVC is a small charity and independent media production company based in South East London. We spec
London, United Kingdom
Dec-18-2014 Marketing Manager, London - Business Information
source:
Marketing Manager, London - Business Information, Trend Forecasting Our client is a leading player i
Camden, London, United Kingdom
Dec-18-2014 SOLARIS SYSTEM ENGINEER/ADMINISTRATOR FRANKFURT 12 MONTHS
source:
SOLARIS SYSTEM ENGINEER/ADMINISTRATOR REQUIRED FOR 12 MONTH CONTRACT BASED IN FRANKFURT, GERMANY. &#
Frankfurt am Main, Hessen, Germany
Dec-18-2014 Senior UX Architect Consultant
source:
City, London, United Kingdom
Dec-18-2014 Software Tester
source:
Harvey Nash Belgium is since many years the loyal partner for clients and professionals. We guarante
Antwerpen, Belgium
Dec-18-2014 .NET C# WCF Developer, Banking
source:
.NET C# WCF Developer, BankingOur client is The leading Bank in the Nordic regions within Investment
Denmark
Dec-18-2014
source:
London, United Kingdom
Dec-18-2014 Assistant Psychologist Band 4 - Neuropsychiatry
source:
The Neuropsychiatry Service offers highly specialist care, treatment and rehabilitation for young pe
Northamptonshire, United Kingdom
Dec-18-2014 Senior BI Developer
source:
Sr. BI Developer Skills: MS BI Stack (SSIS, SSAS, SSRS), SSIS - ETL, OLAP, SSAS Cube development, S
Atlanta, Georgia, United States
Dec-18-2014 PHP Developer
source:
Books Are Fun, the world's leading display marketer of books and gifts is seeking a full time PHP De
Louisville, Colorado, United States
Dec-18-2014 Manager of Penetration Testing Services
source:
A fast growing, Atlanta-based security company focused on information security and compliance for sm
Alpharetta, Georgia, United States
Dec-18-2014 Credit Analyst/Loan Manager
source:
Position Summary: Excellent opportunity for career growth and service oriented individual with one
Wexford, Pennsylvania, United States
Dec-18-2014 Web Analyst/Digital Media
source:
Title: Web Analyst/Marketing Analytic's - Digital Media Job Description Role Overview A midlevel Wen
Atlanta, Georgia, United States
Dec-18-2014 Senior UX Designer
source:
Sr. UX Designer will be in a leadership role in crafting the vision for company's Activity Intellige
Alpharetta, Georgia, United States
Dec-18-2014 Treasury Tax Analyst II
source:
The Treasury Analyst II- Tax position (Tax Analyst) is an integral component of the Treasury Departm
Cleveland, Ohio, United States
Dec-18-2014 Mortgage Underwriter
source:
Mortgage Underwriter Nations Lending Corporation, a full-service National Mortgage Lender founded in
Independence, Ohio, United States
Dec-18-2014 Shipping Clerk/Administrative Assistant
source:
Our Company We all know that success takes the work of talented and dedicated people who are committ
Aurora, Ohio, United States
Dec-18-2014 Data Security Analyst
source:
LOCATION: The Loop - Chicago, IL POSITION OVERVIEW: Focusing on innovation, collaboration and engage
Chicago, Illinois, United States