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 323 jobs posted within 600 days!

Date Description Location
Supplementary Results
Friday
Aug-01-2015 Java Developer - Complex data management applications - €60K
source:
Complex data management applications, high-level Java software development, challenging and dynamic
Antwerpen, Belgium
Aug-01-2015 .NET Software Engineer / .NET Software beheerder
source:
Aartselaar, Antwerpen, Belgium
Aug-01-2015 .NET Front-End Engineer
source:
Aartselaar, Antwerpen, Belgium
Aug-01-2015 Database Marketing Junior
source:
Friday Media Group is a UK-based web company with a clear vision that's expanding in the UK and inte
North, United Kingdom
Aug-01-2015 Softwareentwickler / Softwareentwicklerin C++
source:
Darmstadt, Hessen, Deutschland
Aug-01-2015 TS II - External Loads Engineer - Core
source:
TS II External Loads Engineer Core in GAC SavannahUnique Skills:Requires knowledge of aircraft loads
Savannah, Georgia, United States
Aug-01-2015 ECS/Thermo/Water & Waste Design Engineer - Initi
source:
ECS/Thermo/Water & Waste Design Engineer Initial/Final Phase (TSII) in GAC SavannahUnique Skills:ECS
Savannah, Georgia, United States
Aug-01-2015 System Safety Engineer - Technical Specialist II
source:
System Safety Engineer Technical Specialist II in GAC SavannahUnique Skills:Applicant should have an
Savannah, Georgia, United States
Aug-01-2015 Sales and Marketing Manager
source:
North Sands is looking for a full-time Sales & Marketing Manager to be based in Calgary, Alberta.Nor
Calgary, Alberta (AB), Canada
Aug-01-2015 Warranty Specialist II
source:
Warranty Specialist II in GAC AppletonUnique Skills:Aircraft maintenance experience preferred.Workin
Wisconsin, United States
Aug-01-2015 Flight Control Systems Engineer - Technical Spec
source:
Flight Control Systems Engineer Technical Specialist II in GAC SavannahUnique Skills:The ideal candi
Savannah, Georgia, United States
Aug-01-2015 Technical Specialist II
source:
Technical Specialist II in GAC SavannahUnique Skills:The Structural Test Lab is looking for an Instr
Savannah, Georgia, United States
Aug-01-2015 Aircraft Performance Engineer - Technical Specia
source:
Aircraft Performance Engineer Technical Specialist II in GAC SavannahUnique Skills:The Aircraft Perf
Savannah, Georgia, United States
Aug-01-2015 Configuration/Change Management Lead Engineer II
source:
Configuration/Change Management Lead Engineer II in GAC SavannahUnique Skills:Qualified Candidates M
Savannah, Georgia, United States
Aug-01-2015 Data Integrity Lead Engineer II
source:
Data Integrity Lead Engineer II in GAC SavannahUnique Skills:Check 3D engineering data for conforman
Savannah, Georgia, United States
Aug-01-2015 Certification Engineer - Technical Specialist II
source:
Certification Engineer Technical Specialist II in GAC SavannahUnique Skills:This position requires e
Savannah, Georgia, United States
Aug-01-2015 Aviation Technical Specialist
source:
Aviation Technical Specialist, Pilot Information Center Aviation Technical Specialist
Maryland, United States
Aug-01-2015 SEO Executive
source:
SEO Executive Location: Preston Contract: Full-Time, Permanent Salary: Competitive, based on exper
Bolton, Lancashire, United Kingdom
Aug-01-2015 Aircraft Systems Design Development, Validation
source:
Aircraft Systems Design Development, Validation and Verification Engineer (TSII) in GAC SavannahUniq
Savannah, Georgia, United States
Aug-01-2015 Integrated Marketing Manager
source:
Integrated Marketing Specialist required by global leader of SaaS enterprise applications to work wi
City, London, United Kingdom