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 352 jobs posted within 600 days!

Date Description Location
Supplementary Results
Tuesday
Oct-22-2014 Team Leader: RF & Microwave Design Engineering
source:
Team Leader: RF & Microwave Design Engineering - 45k - 50k My client, a rapidly growing satellite si
Hereford, Herefordshire, United Kingdom
Oct-22-2014 Quality Auditor - Contract
source:
Job Title: Quality AuditorLocation: LondonDuration: 6 month contractThe Client: Fast growing global
London, United Kingdom
Oct-22-2014 Head Of Products-DBAC
source:
Our client one of the leading banks in Doha, Qatar is currently seeking to hire the Head of Products
Qatar
Oct-22-2014 Project Manager - IT Asset Mgt
source:
My client, in the insurance industry, is looking for a Project Manager (IT Asset Management) Job Sum
Dublin, Dublin, Ireland
Oct-22-2014 Senior IOS Engineer - Amsterdam - IOS, High Quality and Traffi
source:
Senior IOS Engineer - Amsterdam - IOS, High Quality and Traffic, Growing Company - € 65.000,-
Amsterdam, Netherlands
Oct-22-2014 Software Sales Specialist
source:
Software Sales Specialist - Software/Simulation/FDTD/FEM/Electromagnetic/Zurich Our client, a market
Switzerland
Oct-22-2014 Senior Java Web Developer
source:
Synergy Consulting Group is looking for Senior Java Web Developer for a full time position in the Cl
Cleveland, Ohio, United States
Oct-22-2014 Senior .NET Developer
source:
POSITION OVERVIEW: Our client company, a leader in administration software development, seeks to fin
Aurora, Illinois, United States
Oct-22-2014 Clinical Research Associate
source:
The clinical research associate (CRA) from IMARC Research, Inc. will work with a sponsoring company
Strongsville, Ohio, United States
Oct-22-2014 Building Maintenance Groundskeeper
source:
We all know that success takes the work of talented and dedicated people who are committed to making
Aurora, Ohio, United States
Oct-22-2014 LIMS Programmer Analyst
source:
Degree and area of specialization: Bachelor's degree required, focus preferred in computer science,
Madison, Wisconsin, United States
Oct-22-2014 Customer Service, Marketing, and Inside Sales Coordinator
source:
Responsibilities: Support three (3) key functions: customer service, sales and product management.
Ohio, United States
Oct-22-2014 Senior Information Security Manager
source:
LOCATION:  The Loop - Chicago, IL POSITION OVERVIEW: Focusing on innovation, collaboration and
Chicago, Illinois, United States
Oct-22-2014 Clinical Analyst - ClinDoc/Beacon/Home Health/Ambulatory
source:
OPPORTUNITY: Our client in Northern California is searching for a permanent Clinical Analyst to be a
Fresno, California, United States
Oct-22-2014 Social Worker/Group Facilitator - 40 hrs/wk
source:
Benjamin Rose Institute on Aging, a leader in Eldercare services and applied research and advocacy i
Cleveland, Ohio, United States
Oct-22-2014 HR Systems Analyst / Developer
source:
London, United Kingdom
Oct-22-2014 Accounting Clerk/Part-Time
source:
Immediate Opening! Geauga Savings Bank, a local Eastside community bank, is seeking an experienced p
Newbury, Ohio, United States
Oct-22-2014 Senior Marketing Executive
source:
Senior Marketing ExecutiveModis are currently searching for a dynamic Senior Marketing Executive. Th
Macclesfield, Cheshire, United Kingdom
Oct-22-2014 Brand Manager
source:
Brand ManagerModis are currently searching for a dynamic Brand Manager. The role is a fantastic oppo
Macclesfield, Cheshire, United Kingdom
Oct-22-2014
source:
Birmingham, Warwickshire, United Kingdom