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 340 jobs posted within 600 days!

Date Description Location
Supplementary Results
Wednesday
Oct-23-2014 Software Application Engineer
source:
With nearly 30 years' experience and offices in three states, our client provides an exceptional ran
Nashville, Tennessee, United States
Oct-23-2014 Systems Analyst/Administrator
source:
Systems Analyst/Administrator Skills: Linux (Redhat), Windows 2008, Apache, JBoss, Tomcat, RDBMS su
Atlanta, Georgia, United States
Oct-23-2014 Senior BI Developer
source:
Sr. BI Developer Skills: MS BI Stack (SSIS, SSAS, SSRS), SSIS - ETL, OLAP, SSAS Cube development, S
Atlanta, Georgia, United States
Oct-23-2014 Clinical Specialist Radiation Therapist required in Dublin
source:
TTM Healthcare are now recruiting a highly experienced Clinical Specialist Radiation Therapist on be
Dublin, Dublin, Ireland
Oct-23-2014 Outpatient Chemical Dependency Supervisor with an Independent Mental H
source:
Cleveland, Ohio, United States
Oct-23-2014 Research Controller
source:
Research Controller This is really one of those opportunities that you come across on rare occasions
London, United Kingdom
Oct-23-2014 Digital Marketing Assistant
source:
LOCATION: Padbury, Nearr Buckingham JOB TITLE: Digital Marketing Assistant SALARY & BENEFITS: Ci
Buckingham, Buckinghamshire, United Kingdom
Oct-23-2014 Portfolio Manager - OTC
source:
Portfolio Manager - OTCOur global Life Sciences OTC Client in Switzerland is now looking for its Por
Nyon, Vaud, Switzerland
Oct-23-2014 Admissions Counselor
source:
The Cleveland Institute of Art is one of the nation's leading independent colleges of art and design
Cleveland, Ohio, United States
Oct-23-2014 Campaign Executive
source:
Buckingham, Buckinghamshire, United Kingdom
Oct-23-2014 Head of Finance and Management Reporting
source:
LOCATION: Padbury, Near Buckingham JOB TITLE: Head of Finance and Management Reporting SALARY & BENE
Buckingham, Buckinghamshire, United Kingdom
Oct-23-2014 IT Service Desk Analyst
source:
We are looking for a Service Desk analyst for a contract to hire role with our client in Wayne, PA.
Wayne, Pennsylvania, United States
Oct-23-2014 Business Analyst - Pittsburgh, PA
source:
Synergy Consulting Group is looking for a Business Analyst for a six month+ contract position in the
Pittsburgh, Pennsylvania, United States
Oct-23-2014 IT focussed Management Consultant
source:
We are currently working with a Brisbane based, leading consulting company that provide specialist b
Brisbane, Brisbane, Australia
Oct-23-2014 Business Development Manager
source:
Employer/ Agency: UCA Consulting Contact Name: Russell Roberts Contact Email: Contact Telephone: Rep
London, United Kingdom
Oct-23-2014 JEE Platform Architect
source:
Optimus Search are currently searching experienced JEE Platform Architects and Backend Developers wi
Berlin, Germany
Oct-23-2014 German Speaking SEO Specialist
source:
The Role The SEO on-site specialist will manage the processes necessary to improve the on-site SEO f
Malta
Oct-23-2014 Swedish Speaking SEO Specialist
source:
The Role The SEO on-site specialist will manage the processes necessary to improve the on-site SEO f
Malta
Oct-23-2014 Director of Clinical Applications Services
source:
Our prestigious Healthcare client is looking for a Director of Clinical Applications Services - for
Qatar
Oct-23-2014 Private Client Servicing Manager Administrator
source:
Private Client Servicing Manager Administrator Glasgow About the opportunity As our Private Client
Glasgow, Lanarkshire, United Kingdom