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 436 jobs posted within 600 days!

Date Description Location
Supplementary Results
Thursday
Nov-28-2014 IT Security Architect Cryptography Phd/Msc Embedded Security
source:
IT Security Architect Cryptography Phd/Msc Embedded Security You will be part of a team focusing on
Zuid-Holland, Netherlands
Nov-28-2014
source:
London, United Kingdom
Nov-28-2014 Business Analyst Market Data Specialist/Client Delivery USA
source:
Business Analyst./Market Data Specialist/Client Delivery - Equities Derivatives Bloomberg/Reuters -
San Jose, California, United States
Nov-28-2014 Business Development/Market Analyst (Transport Technology)
source:
Surrey, United Kingdom
Nov-28-2014 QA Team Lead
source:
QA Team LeadBasic Information:A leading California Tech Firm based in Dublin City is searching for a
Dublin, Dublin, Ireland
Nov-28-2014 Quality & Excellent Coordinator
source:
Job Description & Responsibilities of Quality and Excellence Coordinator: Facilitate extension of Q
West Midlands, United Kingdom
Nov-28-2014 Senior Online Advertising Executive
source:
A leading multi-channel retailer based in Manchester is looking for a creative and motivated candida
North, United Kingdom
Nov-28-2014 Catastrophe Risk Analyst
source:
This is a great opportunity to join a leading Managing Agency and be eventually responsible for all
London, United Kingdom
Nov-28-2014 Java software engineer for mobile automation (Java, Selenium, Android/
source:
We are looking for Java software engineer for mobile automation for a big company in Zurich. JOB GOA
Switzerland
Nov-28-2014 Help Desk Engineer
source:
As a Level I IS Technical Support Specialist you will be required to field support calls, e-mails, c
Chicago, Illinois, United States
Nov-28-2014 Senior IT Support
source:
Job Title: Senior IT Support Key Responsibilities Responsible for all aspects of IT Infrastructure
City, London, United Kingdom
Nov-28-2014
source:
London, United Kingdom
Nov-28-2014 Sales Executive - Amsterdam area
source:
Bi-lingual Account Executive - Recruitment Software High On Target Earnings - Salary and benefit pac
Amsterdam, Noord-Holland, Netherlands
Nov-28-2014
source:
A 1st Tier Retail Bank based in London currently requires a Head of Business Management to join thei
London, United Kingdom
Nov-28-2014 Marketing Associate
source:
We have an immediate opening for a Full time Marketing Associate to support the company's online mar
Beachwood, Ohio, United States
Nov-28-2014 Website & SEO Manager
source:
Website & SEO Manager Symposium is the trading name of Black and White Trading Ltd. We are a dyn
London, United Kingdom
Nov-28-2014 Senior Access Solution Sales Manager
source:
Senior Access Solution Sales Manager My client, a leading ICT/Telecoms company, is currently lookin
Nordrhein-Westfalen, Germany
Nov-28-2014 Senior Data Analyst (SAS, SQL, Modelling, Analytics) Hong Kong based
source:
MAIN PURPOSE OF JOB To deliver analytics services to the APAC client base and support APAC activitie
Hong Kong
Nov-28-2014 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
Nov-28-2014 INTERMEDIATE TECHNICAL ANALYST, CITRIX
source:
With 47 ports of call, 35 vessels, and more than 500 sailings every day, BC Ferries is the largest i
Victoria, British Columbia (BC), Canada