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 226 jobs posted within 1600 days!

Date Description Location
Supplementary Results
Friday
Sep-16-2017 Senior Transport Modeller
source:
Senior Transport Modeller - Warrington - Advisory and Strategic Modelling The Exciting Opportunity:
Warrington, Cheshire, United Kingdom
Sep-16-2017 Senior Traffic Modeller
source:
Senior Traffic Modeller - Croydon (TRA001H9)Arcadis is the leading global Design & Consultancy firm
Croydon, London, United Kingdom
Sep-16-2017 Director Cyber Security Operations and Threat
source:
Prestigious Enterprise Company is currently seeking a Director of Cyber Security Risk Operations and
San Francisco, California, United States
Sep-16-2017 Senior Security Risk Analyst
source:
Seeking an IT Security Risk Analyst for a Fortune 500 Financial Services Organization.The Senior Inf
Northbrook, Illinois, United States
Sep-16-2017 Director Cyber Risk Assurance
source:
Prestigious Enterprise Company is currently seeking a Director of Cyber Risk Assurance. Candidate wi
San Francisco, California, United States
Thursday
Sep-15-2017 Maritime Combat Systems Integration Engineer
source:
Hampshire, United Kingdom
Sep-15-2017 Maritime Communications and Data Link Systems Engineer
source:
Communications and Data Link Systems Engineer - Contract - Hampshire The Maritime Communications and
Hampshire, United Kingdom
Sep-15-2017 Innovation Project Leader
source:
Innovation Project LeaderProvide are working with a world leading and respected R&D company within e
Cambridge, Cambridgeshire, United Kingdom
Sep-15-2017 German Recruitment Consultant
source:
ExecutiveSurf is a new generation executive search firm that helps world-class multinational firms t
London, United Kingdom
Sep-15-2017 Process and Syste Engineer - Packaging
source:
Position duties and responsibilities . Direct and execute local and global projects . Develop contin
Switzerland
Sep-15-2017 Administrator - Havant - Contract to Perm
source:
Havant, Hampshire, United Kingdom
Sep-15-2017 HR Insight Analyst
source:
HR Insight Analyst - London - Financial Services My client, a leading financial services institutio
London, United Kingdom
Sep-15-2017 Service Delivery Manager/Service Desk Manager
source:
Service Delivery Manager/Service Desk ManagerA fantastic opportunity has arisen for a Service Delive
Jersey, Channel Isles, United Kingdom
Sep-15-2017 User Experience Consultant/UX Consultant
source:
User Experience Consultant A strategically minded and solution focused UX Consultant is required to
Dublin, Dublin, Ireland
Sep-15-2017 Senior Tax Accountant
source:
Prepare and light review complex individual, trust, estate, and high net worth tax returns at feder
Fairlawn, Ohio, United States
Sep-15-2017 Cyber Security Consultant (Technical)
source:
Cyber Security Consultant (Technical) Cyber Security/SABSA/CISSP/CISM/CCSP/CCP/CCNP - Security/Secu
Dublin, Dublin, Ireland
Sep-15-2017 Senior/Lead Electronics Engineers - breakthrough technology
source:
Senior/Lead Electronics Engineers - Nanotechnology Cambridgeshire - salary negotiable for the right
Cambridge, Cambridgeshire, United Kingdom
Sep-15-2017 Finance Manager
source:
As a Finance Manager, you will be required to: Manage detailed and accurate month end closing proces
Hampshire, United Kingdom
Sep-15-2017 Senior Software Engineer (C/C++, Linux, CLI/scripting)
source:
Enigma People Solutions is recruiting an experienced Software Engineer (C/C++, Linux, CLI/Scripting
Glasgow, Lanarkshire, United Kingdom
Sep-15-2017 L3/L4 Technical Support Consultant
source:
My client is looking for a L3/L4 technical support consultant, who has experience in eDiscovery.Star
Budapest, Hungary