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 412 jobs posted within 1600 days!

Date Description Location
Supplementary Results
Monday
Aug-15-2017 Senior Web Developer
source:
Company Profile Talis Clinical, LLC provides health technology supporting clinicians to impact p
Streetsboro, Ohio, United States
Aug-15-2017 Product Manager/Metals Industry (2974JMS080317)
source:
Company Description Company has 40 years of experience Produces products to support the foundry and
Cleveland, Ohio, United States
Aug-15-2017 Full Stack Developer - Artificial Intelligence (Ruby & Javascript)
source:
Full Stack Developer - Artificial Intelligence (Ruby & Javascript) An innovative global leader in Ma
London, United Kingdom
Aug-15-2017 Cyber Security Concept Developer
source:
Description We have a Cyber Security Concept Developer role to fill in the Netherlands. Three are at
Netherlands
Aug-15-2017 Data Research and Collection - Real Estate & Mortgage Data
source:
Type - Temp (approximately 3 months to start, possibility for extension) Rate - $16-17/hr (no benefi
Irvine, California, United States
Aug-15-2017 NQ Solicitor/NQ Legal Executive/Paralegal (1+ PQE)
source:
Job TitleNQ Solicitor/NQ Legal Executive/Paralegal (1+ PQE) BasedBirmingham Head Office Reporting
Birmingham, United Kingdom
Aug-15-2017 Brand Manager
source:
Bimbo Bakeries, Brand Manager, Horsham, PA, research market conditions to determine potential sales
Horsham, Pennsylvania, United States
Aug-15-2017 Earth Observation Application Support Engineer
source:
Earth Observation Application Support EngineerPermanent PositionLocation: HarwellWe are looking for
Harwell, Oxfordshire, United Kingdom
Aug-15-2017 Research Analyst - Financial Products
source:
I am working with a global partner to recruit a Research Analyst. You will manage the journey of fin
Peterborough, Cambridgeshire, United Kingdom
Aug-15-2017 Cyber Security Risk Analyst
source:
Prestigious Fortune 500 Company is currently seeking a Cyber Security Risk Analyst. Candidate will a
Northbrook, Illinois, United States
Aug-15-2017 Director of Cyber Risk Assurance Frameworks
source:
Looking for a Director of Cyber Risk Assurance - you will be building from scratch the team and deve
San Francisco, California, United States
Aug-15-2017 EMEA Talent Tech Sourcer
source:
We are searching for a EMEA Talent IT Sourcer. The multi-large world wide client of us is based in A
Amsterdam, Noord-Holland, Netherlands
Aug-15-2017 Graduate Inside Sales-Telesales Representative-Business Development-Te
source:
Telesales -Graduate Inside Sales Representative-Business Development -Telesales We are looking for a
City, London, United Kingdom
Aug-15-2017 Oracle Solution Architect
source:
Oracle Solution Architect required by Whitehall Resources on a permanent basis for our client based
Saudi Arabia
Aug-15-2017 Quant Analysts Required - High Earning Potential
source:
Quant Analysts Required - High Earning Potential - Apply WithinQuant Analysts required for role with
London, United Kingdom
Aug-15-2017 Social Researcher
source:
Do you have a background in social or behavioural research? Are you interested in why people fundame
Milton Keynes, Buckinghamshire, United Kingdom
Aug-15-2017 Technical Publications Engineer
source:
Technical Publications AuthorA Technical Publications Author is required to work on an eleven month
Preston, Lancashire, United Kingdom
Aug-15-2017 Project Manager - R&D
source:
Milton Keynes, Buckinghamshire, United Kingdom
Aug-15-2017 Robotic Simulation Lead
source:
At Tata Technologies we make product development dreams a reality by designing, engineering and vali
Gaydon, Warwickshire, United Kingdom
Aug-15-2017 Scala Developer | Leeds | WEB API's
source:
Lead Scala Developer with Scala, Web based API and agile experience required by Local Authority base
Leeds, Yorkshire, United Kingdom