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 338 jobs posted within 1600 days!

Date Description Location
Supplementary Results
Sunday
Jul-25-2016 Mobile & Messaging | iPhone | Blackberry | Nokia | Manager | Consultan
source:
Mobile & Messaging | iPhone | Blackberry | Nokia | Manager | Consultant An international law firm is
Colchester, Essex, United Kingdom
Jul-25-2016 Deep Learning Specialist - Contract - Tensorflow/Theanos
source:
NLP/Semantic client based in Belgium require NLP and Deep Learning Specialists to join their team. T
Belgium
Jul-25-2016 UNIX/C Developer Programmer-Expert level, Senior-UNIX/C++ Multithreadi
source:
This is an a ongoing need for Senior Expert level UNIX/C Software Developer Programmer candidates wi
New York, New York, United States
Jul-25-2016 Trainer
source:
Manchester, Lancashire, United Kingdom
Jul-25-2016 Senior UX Researcher
source:
Our Fortune 500 direct client in Chevy Chase, Maryland is looking to hire a UX Researcher for a perm
Chevy Chase, Maryland, United States
Jul-25-2016 Senior C# Developer/Senior .NET Programmer
source:
Our client has an exciting opening for an experienced C#.NET developer to support and enhance conten
Colorado Springs, Colorado, United States
Jul-25-2016 Medical Writer - North East - World Leader!
source:
Medical Writer - North East - World LeaderMy client is offering a great opportunity to get into the
Kingston, Yorkshire, United Kingdom
Jul-25-2016 .NET Applications Developer
source:
Company Profile Talis Clinical, LLC is a company with a higher purpose, our priorities are first to
Cleveland, Ohio, United States
Jul-25-2016 Learning and Development Specialist
source:
Manchester, Lancashire, United Kingdom
Jul-25-2016 Web Applications Developer with Top Secret Clearance
source:
Perm, direct hire opening in Chantilly, Va. for a .NET Web Applications Developer. The ideal candid
Chantilly, Virginia, United States
Jul-25-2016 Senior Infrastructure Security Architect
source:
Senior Infrastructure Security Architect Large Exchange Firm in Downtown Chicago is looking for a Se
Chicago, Illinois, United States
Jul-25-2016 IAM Principal Engineer
source:
IAM Principal Engineer Prestigious Financial Institution is recruiting for an Identity & Access Man
Chicago, Illinois, United States
Jul-25-2016 Senior Data Scientist
source:
We are looking for an experienced data scientist to work within a large and progressive data science
Cardiff, South Glamorgan, United Kingdom
Jul-25-2016 Senior User Experience Researcher with TS/SCI Clearance
source:
Senior User Experience Researcher to support a program at a federal agency. The Senior User Experien
Springfield, Virginia, United States
Jul-25-2016 Clinical Research Associates (CRAs)
source:
The clinical research associate (CRA) from IMARC Research, Inc. will work with a sponsoring company
Minneapolis, Minnesota, United States
Jul-25-2016 Director of Strategy - Global Technology
source:
Director of Strategy - Global Technology Exciting opportunity to develop long-range Technology Strat
Atlanta, Georgia, United States
Jul-25-2016 Clinical Auditor
source:
The Clinical Auditor (CA) from IMARC Research, Inc. will work with a sponsoring company or CRO in th
Minneapolis, Minnesota, United States
Jul-25-2016 Clinical Auditor
source:
The Clinical Auditor (CA) from IMARC Research, Inc. will work with a sponsoring company or CRO in th
Strongsville, Ohio, United States
Jul-25-2016 Principle Electronics Engineer/Consultant
source:
This role, working for a well established company in Surrey, combines the technical hands on ability
Surrey, United Kingdom
Jul-25-2016 Retail or Customer Service experience? Full Time / Part time
source:
Do you have retail or customer service experience? Immediate starts sought after for the summer!Get
City, Sheffield, United Kingdom