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 421 jobs posted within 1600 days!

Date Description Location
Supplementary Results
Friday
Dec-03-2016 SEO Manager
source:
SEO Manager, Fast growing digital agency, Manchester City Centre Foward Role are working exclusively
North, United Kingdom
Dec-03-2016 Planning Associate Director Award Winning Insurance Brands
source:
London, United Kingdom
Thursday
Dec-02-2016 Public Relations and Communications Assistant
source:
We are searching for friendly, outgoing, and energetic individuals to assist us in meeting our clien
Addison, Texas, United States
Dec-02-2016 Call Center/Customer Service Representative - Austintown, OH
source:
Call Center/Customer Service Representative - Austintown, OH As a leading provider of call center so
Ohio, United States
Dec-02-2016 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
Dec-02-2016 Senior GRC Information Security Professional
source:
*Can be located in Carrollton, TX or McLean, VA* THIS POSITION CAN BE LOCATED IN OUR MCLEAN, VA OR C
Carrollton, Texas, United States
Dec-02-2016 Senior GRC Security Specialist
source:
Prestigious Enterprise Company is currently seeking a Sr. GRC Engineer with ISO 27K experience. Cand
Virginia, United States
Dec-02-2016 Senior GRC Security Specialist
source:
Prestigious Enterprise Company is currently seeking a Sr. GRC Engineer with ISO 27K experience. Cand
Carrollton, Texas, United States
Dec-02-2016 Mainframe Security Administrator - RACF, ACF2 or Top Secret
source:
Mainframe Security Administrator - RACF, ACF2 or Top Secret Downers Grove, IL Prestigious global co
Downers Grove, Illinois, United States
Dec-02-2016 Senior GRC Information Security Professional
source:
*Can be located in Carrollton, TX or McLean, VA* THIS POSITION CAN BE LOCATED IN OUR MCLEAN, VA OR C
Virginia, United States
Dec-02-2016 Business Architect
source:
Prestigious Enterprise Company is currently seeking a Business Architect. Candidate will partner wit
Atlanta, Georgia, United States
Dec-02-2016 Enterprise Architect
source:
Prestigious Enterprise Organization is seeking an Enterprise Architect. This position is responsible
Lake Forest, Illinois, United States
Dec-02-2016 Senior Data Scientist
source:
Switzerland
Dec-02-2016 Business Architect
source:
Prestigious Enterprise Company is currently seeking a Business Architect. Candidate will partner wit
Alpharetta, Georgia, United States
Dec-02-2016 Technical Sourcer - Dublin
source:
Technical Sourcer - Dublin Based in the heart of Dublin's Silicon Docks, our client is renowned for
Dublin, Dublin, Ireland
Dec-02-2016 Power Electronics Engineer - Research & Development
source:
Power, Electronics, IGBT, Motor Drives, Soft Starts, HVDC, EMC, Power Systems, InvertersTitle: Power
Lincoln, Lincolnshire, United Kingdom
Dec-02-2016 Training Specialist
source:
This is an excellent opportunity for an experienced candidate to further develop their career as par
Bracknell, Berkshire, United Kingdom
Dec-02-2016 PPC Manager
source:
PPC Manager - Permanent - London - Competitive salary + company benefitsMy client connect thousands
London, United Kingdom
Dec-02-2016 Mainframe Batch support - JCL, Glassfish, Java
source:
We are hiring for Mainframe Batch support - JCL, Glassfish, Java with one our reputed client. Job Ti
Budapest, Hungary
Dec-02-2016 Director of Content Delivery
source:
Director of Content Delivery Our world renowned client is looking to add a Director of Content Deliv
Atlanta, Georgia, United States