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 452 jobs posted within 1600 days!

Date Description Location
Supplementary Results
Wednesday
Jun-21-2018 Customer Service or Call Centre Experience? Students welcome!
source:
If you've got customer service or call centre experience, then you are just the person HOME Fundrais
City, Birmingham, United Kingdom
Jun-21-2018 Customer service / Sales experience? Part time / Full time!
source:
Exeter, Devon, United Kingdom
Jun-21-2018 Sales / Customer service assistants - Immediate start
source:
Our client, based in Liverpool is currently recruiting for Sales / Customer service assistants to jo
City, Liverpool, United Kingdom
Jun-21-2018 Retail or Customer Service experience? Immediate start!
source:
Do you have Retail or customer service experience? Put your hard earned skills to great use and get
Hackney, London, United Kingdom
Jun-21-2018 Retail or Customer Service Assistants (Change your career now)
source:
Retail or customer service assistants - want a change of career for something more satisfying? Why n
City, Leeds, United Kingdom
Jun-21-2018 Retail or Customer Service Assistants (Change your career today)
source:
Get paid to save lives! If you work in retail or customer service and would like a change of career
City, Glasgow, United Kingdom
Jun-21-2018 Sales or Customer service experience wanted (full or part time)
source:
Sales or Customer service experience wanted - Get paid to save lives in Cardiff! Students and Gradua
City, Cardiff, United Kingdom
Jun-21-2018 Retail or Sales Assistants (Change your career to sales today)
source:
Are you a retail or sales assistant who would like to get more out of your job? How about getting pa
City, Dundee, United Kingdom
Jun-21-2018 Customer service or sales skills? Part time / Full time jobs
source:
Have you got customer service or sales skills? Great! Then look no further for your next amazing job
Coventry, Warwickshire, United Kingdom
Jun-21-2018 Senior IT Citrix Administrator
source:
Position SummaryThe Citrix Administrator's role is to ensure the stability, integrity, and efficient
Norcross, Georgia, United States
Jun-21-2018 Sixth Form Learning Mentor
source:
School 21 is a pioneering, 4 to 18 school for girls and boys in Stratford, East London Join our ama
Newham, London, United Kingdom
Jun-21-2018 SalesForce Systems Analyst
source:
*Must be SalesForce 201 Admin certified* Prestigious Enterprise Company is currently seeking a Sales
Virginia, United States
Jun-21-2018 Senior MicroStrategy Developer
source:
*we are unable to sponsor for this permanent Full time role* Prestigious Enterprise Company is curre
Virginia, United States
Jun-21-2018 Senior IT Security Engineer
source:
Looking for a candidate with 2-4 years Infrastructure, Enterprise, Security, OS, Networking, SIEM, I
Chicago, Illinois, United States
Jun-21-2018 Senior Financial Developer - Python
source:
Financial Python Developer McLean, VA $100-130K +bonus Design, develop and support systems within t
Virginia, United States
Jun-21-2018 Solution Architect
source:
POSITION OVERVIEW: TeamBradley is collaborating with a thriving financial services corporation that
United States
Jun-21-2018 Sales Manager - Cleveland History Center
source:
RESPONSIBILITY: Responsible to the Director of the Cleveland History Center (CHC), headquarters of W
Cleveland, Ohio, United States
Jun-21-2018 Autonomous MCM Systems Technical Lead
source:
Autonomous MCM Systems Technical Lead role working across the full systems life cycle with a current
Templecombe, Somerset, United Kingdom
Jun-21-2018 Workforce Manager
source:
Workforce Manager - Digital bankAre you passionate about Customer Service, operations, leadership, a
City, London, United Kingdom
Jun-21-2018 Executive Assistant to a EMEA CIO
source:
London, United Kingdom