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 376 jobs posted within 1600 days!

Date Description Location
Supplementary Results
Today
Jan-22-2018 Sales / Customer service experience? Start ASAP
source:
Do you have Sales experience or feel that you thrive in a customer service focused environment? Woul
Southwark, London, United Kingdom
Jan-22-2018 Retail or Customer Service experience? Immediate start!
source:
Do you have Retail or customer service experience? Put your hard earned skills to great use and get
Hackney, London, United Kingdom
Jan-22-2018 Sales / Customer service experience? Start ASAP
source:
Do you have Sales experience or feel that you thrive in a customer service focused environment? Woul
Southwark, London, United Kingdom
Jan-22-2018 Customer Service / Call Centre Experience? Immediate start
source:
If you've got customer service or call centre experience, then you are just the person our client, H
Southwark, London, United Kingdom
Saturday
Jan-21-2018 Senior Java Web Application Developer
source:
McLean, VA We are currently seeking a Financial Model Development Senior who specializes in Web bas
Virginia, United States
Jan-21-2018 Trader - French - Leiden
source:
An international trading house based in Leiden that consists of four all-round import and export co
Leiden, Zuid-Holland, Netherlands
Jan-21-2018 Ranch Life Director
source:
Looking for a career where you can make adifference while making a living? Where you can be part of
Palatka, Florida, United States
Jan-21-2018 Graduate TA's and LSA's
source:
Graduate TA's and LSA's Are you a Graduate looking to train to become a Teacher? Are you based
Leighton Buzzard, Bedfordshire, United Kingdom
Jan-21-2018 Maths Graduate Teacher Assistant - Tower Hamlets
source:
Maths Graduate Teacher Assistant - Tower Hamlets Are you a Maths Graduate looking to train to become
Tower Hamlets, London, United Kingdom
Jan-21-2018 Maths Teacher Training in Enfield
source:
Maths Teacher Training in Enfield Would you like the opportunity to join Academics Advance? Are you
Enfield, Middlesex, United Kingdom
Jan-21-2018 Teacher Training in Hackney
source:
Teacher Training in Hackney Are you a Maths Graduate looking to train to become an Mathematics Teach
Hackney, Derbyshire, United Kingdom
Jan-21-2018 Teacher Training
source:
Teacher Training Are you an English Graduate looking to train to become an English Teacher? Are you
Hackney, Derbyshire, United Kingdom
Friday
Jan-20-2018 IT Security Analyst
source:
Prestigious Enterprise Institution is currently seeking an IT Security Analyst. Candidate will asses
Chicago, Illinois, United States
Jan-20-2018 Financial Python Backend Developer/Engineer Professional
source:
Looking for a Financial Developer/Engineer Professional that has Python Backend Developement Salary:
Virginia, United States
Jan-20-2018 Mobile Technical Manager
source:
Looking for a Mobile Technical Manager Looking for a candidate to build Mobile Applications for the
Irving, Texas, United States
Jan-20-2018 Application Developer .NET, C#
source:
Application Developer .Net, C# - PRA HEALTH SCIENCES, Mannheim area For our growing drug safety sy
Mannheim, Germany
Jan-20-2018 Materials Specialist/FEMA Analysis
source:
Materials Specialist require to investigate and diagnose problems and recommend improvements used in
Middlesex, United Kingdom
Jan-20-2018 UX Designer - Newbury
source:
UX Designers of all levels required for my client, a leading Software business based in Newbury. The
Newbury, Berkshire, United Kingdom
Jan-20-2018 Paralegal - Legal Support - Compliance - Commercial Contracts
source:
Paralegal/High Wycombe/6 months Contract/Up to 23 GBP (Per Hour) This role supports the global safet
High Wycombe, Buckinghamshire, United Kingdom
Jan-20-2018 Functional Safety Consultant - ISO 26262 United Kingdom
source:
The Company ConSol Partners are currently seeking an experienced Functional Safety Consultant to joi
West Midlands, United Kingdom