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 326 jobs posted within 600 days!

Date Description Location
Supplementary Results
Monday
Sep-01-2015
source:
Glasgow, Lanarkshire, United Kingdom
Sep-01-2015 Analyst / Developer - Agile / Spring / Eclipse / Java / Jenkins
source:
Analyst / Developer - Agile / Jenkins / SVN / Spring / Eclipse / Java EXCITING NEW OPPORTUNITY IN O
Leeds, United Kingdom
Sep-01-2015 Programme Leader for Human Factors (29302)
source:
My client, a leading automotive manufacturer, based in Warwickshire, is looking to recruit a Program
Gaydon, Warwickshire, United Kingdom
Sep-01-2015 Senior Technical Manager (Pets) - Essex
source:
Senior Technical Manager (Pets) Working for a world-leading animal healthcare company the Senior Tec
Essex, United Kingdom
Sep-01-2015 Senior Procurement Manager - West London
source:
Senior Procurement Manager - West LondonWorking for FTSE 30 client, as a member of the Procurement t
Brentford, Middlesex, United Kingdom
Sep-01-2015 Asset Control Data Model Owner
source:
This is an important role to own the Asset Control data model (Financial Reference Data Framework) a
Amsterdam, Noord-Holland, Netherlands
Sep-01-2015 Asset Control Analytics Owner
source:
The Middle Office is a critical customer segment for Asset Control and its solutions are often used
Amsterdam, Noord-Holland, Netherlands
Sep-01-2015 Account Executive (Native German Speaker)
source:
German Account Executive (UK, London based)Company: SavooDepartment: Sales, reporting to the Country
London, United Kingdom
Sep-01-2015 Electrical Systems Engineer
source:
My client, a leading automotive manufacturer, based in Warwickshire, is looking to recruit an Electr
Gaydon, Warwickshire, United Kingdom
Sep-01-2015 Marketing Manager - 2730
source:
INDUSTRY SEGMENT: Medical Device/SurgicalDevice DESCRIPTION: Our client, a multinational manufactur
Toronto, Ontario (ON), Canada
Sep-01-2015
source:
Halifax, Yorkshire, United Kingdom
Sep-01-2015 IP Solution Manager
source:
IP Solution Manager We are currently recruiting for our client, a prestigious telecommunications com
Paris, France
Sep-01-2015 Cloud Service/Product Advisor
source:
Cloud Service/Product Advisor We are currently recruiting for our client, a prestigious telecommunic
China
Sep-01-2015 Advertising Support Executive
source:
WS Advertising is a locally based award winning advertising, design and digital agency. Servicing a
Milton Keynes, Buckinghamshire, United Kingdom
Sep-01-2015 Commercial Litigation Lawyer
source:
Prestigious Buffalo, NY based Law Firm seeks attorney tojoin our expanding Commercial Litigation Dep
Buffalo, New York, United States
Sep-01-2015 Procurement Specialist
source:
This position will be responsible for facilitating strategic sourcing activities within IT. This ent
Oak Brook, Illinois, United States
Sep-01-2015 Technical Architect - Python, PHP, Node.JS, MongoDB
source:
London, United Kingdom
Sep-01-2015 Head of UX/User Experience & Design
source:
London, United Kingdom
Sep-01-2015 Internal Recruitment Manager - Recruitment Consultancy-Bristol
source:
Internal Recruitment Manager - Recruitment Consultancy - BristolISL Recruitment is looking to hire a
Bristol, Somerset, United Kingdom
Sep-01-2015 System Engineer
source:
System engineerOn behalf of our client, we are currently looking for an experienced System Engineer.
Lausanne, Vaud, Switzerland