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 1600 days!

Date Description Location
Supplementary Results
Tuesday
Sep-20-2017 Senior Security Risk Analyst
source:
Senior Security Risk Analyst $90-100K Northbrook, IL Prestigious Organization is seeking a Senior I
Northbrook, Illinois, United States
Sep-20-2017 Director of Security Risk, Governance and Compliance
source:
Seeking an individual to head the Cyber Risk and Assurance team for a prestigious Financial Services
San Francisco, California, United States
Sep-20-2017 Director of Cyber Threat and Vulnerability Management
source:
Seeking a Director of Cyber Threat and Vulnerability Management for a prestigious Financial Services
San Francisco, California, United States
Sep-20-2017 Data Policy Risk Engineer/DLP
source:
Permanent Full time role Prestigious Global Company is currently seeking a Risk Security Engineer fo
Chicago, Illinois, United States
Sep-20-2017 System Engineer
source:
System Engineer$60-85K Prestigious Organization is seeking an experienced IT self-starter with a pas
Niles, Illinois, United States
Monday
Sep-19-2017 Business Analyst - Card Processing Solutions - Banking
source:
Position: Business Analyst - Card Processing - Banking We are seeking a Business Analyst to assist o
London, United Kingdom
Sep-19-2017 Senior Financial Analyst - 6 month contract
source:
Sr Financial Analyst Description: Manages and analyzes monetary resources and affairs within an or
Bakersfield, California, United States
Sep-19-2017 Senior Product Designer - Berlin (Permanent)
source:
Senior Product Designer - Berlin (Permanent) Our client is a mobile applications marketing start-up
Berlin, Germany
Sep-19-2017 Pega DevOps Engineer - Global Client Onboarding
source:
Pega DevOps Engineer - Global Client OnboardingProfile The Pega DevOps Engineer will work in both pr
Utrecht, Netherlands
Sep-19-2017 Project Coordinator (NATO)
source:
*SC/NATO SECRET CLEARANCE REQUIRED*Role - Cyber Security Project CoordinatorLocation - Mons, Belgium
Mons, Hainaut, Belgium
Sep-19-2017 Dutch speaking Active Directory (AD) Architect
source:
Proteus Europe is searching for a Dutch speaking Active Directory (AD) Architect to join a prestigio
Mechelen, Antwerpen, Belgium
Sep-19-2017 Senior Technical Consultant (5G)
source:
My client is a urgently looking for a Senior Technical Consultant to be based in either France, Germ
Germany
Sep-19-2017 Derivatives Operations Manager
source:
Here is your chance to make an impact on a highly entrepreneurial organization. This is a start-up o
Topeka, Kansas, United States
Sep-19-2017 Network/Linux Administrator
source:
Network/Linux AdministratorSeattle, WA 98104Direct Hire85K - 100K OverviewOur client is looking for
Seattle, Washington, United States
Sep-19-2017 Senior Clinical Project Manager - Clinical Trials
source:
Senior Clinical Project Manager - Clinical TrialsLeading global Pharma client require a Senior Clini
Czech Republic
Sep-19-2017 Senior High Precision Time Specialist
source:
My client is a urgently looking for a Senior High Precision Time Specialist to be based in either F
Germany
Sep-19-2017 Recruitment Consultants
source:
Maximise Recruitment are a division of Maximise IT Solutions and so are ideally placed to understand
Bristol, Somerset, United Kingdom
Sep-19-2017 Recruitment Consultants
source:
Maximise Recruitment are a division of Maximise IT Solutions and so are ideally placed to understand
Bristol, Somerset, United Kingdom
Sep-19-2017 Network Data Strategist Lead
source:
Seeking a Network Data Strategist Lead Well known company seeking a Telecom Vendor Management Lead.
Wilmington, Delaware, United States
Sep-19-2017 Full Stack Javascript Developer
source:
Who we are Altus Analytics, a business of Altus Group, is the leading global technology partner to t
Toronto, Ontario (ON), Canada