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 343 jobs posted within 600 days!

Date Description Location
Supplementary Results
Wednesday
Jul-02-2015 Sourcing Analyst
source:
Description: This position is responsible for sourcing, ensuring a cost effective and timely flow of
Deerfield, Illinois, United States
Jul-02-2015 Energy Efficiency Expert
source:
Job DescriptionEnergy Efficiency ExpertHours of workFull time, 40 hours per week, Monday to Friday,
Bristol, Gloucestershire, United Kingdom
Jul-02-2015 Procurement Specialist
source:
This position will be responsible for facilitating strategic sourcing activities within IT. This ent
Oak Brook, Illinois, United States
Jul-02-2015 LabVIEW Developer/Scientific Software Engineer
source:
LabVIEW Developer/Scientific Software Engineer required for fast growing developer of optical fibre
Elstree, Hertfordshire, United Kingdom
Jul-02-2015 Senior Java Developer
source:
PermanentDiamond is one of the most advanced scientific facilities in the world, and its pioneering
Oxford, Oxfordshire, United Kingdom
Jul-02-2015 UX Specialist
source:
UX Specialist/User Research/UX Design/Customer Experience* Great Manchester 30 - 35k.*We are looking
Manchester, Lancashire, United Kingdom
Jul-02-2015 User Researcher
source:
User Experience Researcher (UX)Central LondonMy client a leading consultancy based in the heart of L
London, United Kingdom
Jul-02-2015 Network Infrastructure operations specialist
source:
Network Infrastructure operations specialist Permanent DMSG, Digital Managed Services Group, is an i
Cardiff, South Glamorgan, United Kingdom
Jul-02-2015 Fixed Income Index Quant Analyst
source:
Leading, medium sized firm who continues to enjoy year-on-year revenue growth are looking to expand
London, United Kingdom
Jul-02-2015 DevOps Engineer
source:
Cambridge, Cambridgeshire, United Kingdom
Jul-02-2015 Mid/Senior PHP Web Developer
source:
Mid/Senior PHP Web Developer (PHP, OOP, eCommerce, HTML, CSS, JavaScript, Magento, Zend, MySQL ) - U
Leicester, Leicestershire, United Kingdom
Jul-02-2015 Senior Software Engineer - South Wales
source:
I am currently recruiting for a Senior Software Engineer to join a global, award-winning engineering
Cardiff, South Glamorgan, United Kingdom
Jul-02-2015 Bilingual Customer Service Consultant - Software Support
source:
Bilingual Customer Service Consultant -Software Support (German or Dutch) Brighton circa 25k, plus b
Brighton, Sussex, United Kingdom
Jul-02-2015 Datacenter Architect - Openstack/Cloud Virtualisation
source:
My client is seeking a candidate with comprehensive understanding and can master the technology know
China
Jul-02-2015 Product Consultant
source:
Role Summary Product Consultants are talented individuals; able to evolve business requirements and
Nottingham, Nottinghamshire, United Kingdom
Jul-02-2015 Columbus Immigration Paralegal
source:
Our client is among the 200 largest law firms in the country (AmLaw 200). This firm is currently se
Columbus, Ohio, United States
Jul-02-2015 Account Manager - leading Manchester agency
source:
Our client is a leading integrated agency based just outside Manchester. They are an independent age
North, United Kingdom
Jul-02-2015 UX Architect
source:
Our client helps solve complex IT problems with simple software solutions. Its software has been in
Massachusetts, United States
Jul-02-2015 Medical Science Liaison - 2719
source:
INDUSTRY: Pharmaceutical DESCRIPTION: Our client, a leading global pharmaceutical company, is curr
Vancouver, British Columbia (BC), Canada
Jul-02-2015 Director, Surgical and Interventional Services
source:
Director, Surgical and Interventional ServicesLegacy Good Samaritan Medical CenterLegacy HealthPortl
Portland, Oregon, United States