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 375 jobs posted within 600 days!

Date Description Location
Supplementary Results
Wednesday
Dec-18-2014 Medical Scientific Liaison / MSL contract
source:
Job Title: Medical Scientific Liaison / MSLLocation: Field based national role, mainly covering clie
Berkshire, United Kingdom
Dec-18-2014 Senior Medical Information Officer
source:
Job Title: Senior Medical Information OfficerLocation: BerkshireDuration: ASAP - PermanentThe Client
Berkshire, United Kingdom
Dec-18-2014 Senior Regulatory Affairs Specialist
source:
Job Title: Senior Regulatory Affairs SpecialistLocation: BerkshireDuration: ASAP - PermanentThe Clie
Berkshire, United Kingdom
Dec-18-2014 Lean Manufacturing Supervisor
source:
Our client, headquartered in Akron, Ohio, is the leading manufacturer and marketer of branded health
Akron, Ohio, United States
Dec-18-2014 Clinical Trial Assistant (CTA)
source:
Job Title: Clinical Trial Assistant (CTA)Location: BuckinghamshireDuration: Minimum 12 month contrac
Buckinghamshire, United Kingdom
Dec-18-2014 Principal Medical Information Pharmacist
source:
Job Title: Principal Medical Information PharmacistLocation: BerkshireDuration: ASAP - PermanentThe
Berkshire, United Kingdom
Dec-18-2014
source:
London, United Kingdom
Dec-18-2014 Banking Office Executive - Permanent
source:
Glasgow, Lanarkshire, United Kingdom
Dec-18-2014 UX Visual Designer
source:
UX Visual Designer Extra Technology is currently recruiting on behalf of a leading global software v
Czech Republic
Dec-18-2014 Data Scientist/Modeller, Insight and Analytics, London
source:
Data Scientist/Modeller, Insight and Analytics, London My client are a leading organisation within t
London, United Kingdom
Dec-18-2014 Test Automation Specialist
source:
Test Automation Specialist Extra Technology is currently recruiting on behalf of a leading global so
Czech Republic
Dec-18-2014 Senior Java Developer
source:
Senior Java Developer Extra Technology is currently recruiting on behalf of a leading global softwar
Czech Republic
Dec-18-2014 Assurance Senior Associate- Flexible Work Options
source:
PwC is the leading practice in tax, assurance and advisory in Scotland and offer a diverse range of
Aberdeen, Aberdeenshire, United Kingdom
Dec-18-2014 Assurance Senior Associate- Flexible Work Options
source:
PwC is the leading practice in tax, assurance and advisory in Scotland and offer a diverse range of
Glasgow, Lanarkshire, United Kingdom
Dec-18-2014 Service Delivery Analyst - Investment
source:
Stirling based opportunity for a Service Delivery Analyst to provide day-to-day Market Data support
Stirling, Stirlingshire, United Kingdom
Dec-18-2014 Digital Strategy Analyst
source:
North, United Kingdom
Dec-18-2014 Senior Wireless Test System Architect
source:
eCRM Euro is looking for a Senior Wireless Test System Architect. This position focuses on the resea
Bayern, Germany
Tuesday
Dec-17-2014 Sales/Marketing Data Analyst
source:
A Data Analyst is needed for a marketing organization to analyze real-estate data and associated dat
Lawrenceville, Georgia, United States
Dec-17-2014 UI/UX Specialist
source:
Opportunity to work with the best in the industry 6 month contract Central Dublin location, close to
Dublin, Dublin, Ireland
Dec-17-2014 Senior Exchange and Messaging Operations Engineer
source:
Prestigious Enterprise Company is currently seeking a Sr. Exchange and Messaging Operations Engineer
Virginia, United States