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 355 jobs posted within 600 days!

Date Description Location
Supplementary Results
Monday
Apr-22-2014 Senior Staff Nurse
source:
ESSENTIAL QUALIFICATIONS: RNMH/LD/RMN or equivalent ROLE SUMMARY: The post-holder will provide profe
Norfolk, United Kingdom
Apr-22-2014 Night Co-Ordinator - Norfolk
source:
ESSENTIAL QUALIFICATIONS - RNMH/LD/RMN or equivalentROLE SUMMARY:The post-holder will provide profes
Norfolk, United Kingdom
Apr-22-2014 Volunteer Program Manager
source:
LAKE COUNTY COUNCIL ON AGING Position Title: Volunteer Services Program Manager Provide direction, c
Mentor, Ohio, United States
Apr-22-2014 Certified Health Education Specialist (CHES) - Social Work
source:
Certified Health Education Specialist (CHES) Position: Certified Health Education Specialist Departm
Cleveland, Ohio, United States
Apr-22-2014 Study Nurse - Dresden, Germany
source:
Aerotek Scientific is currently recruiting a Study Nurse for a clinical site near Dresden, Germany t
Dresden, Sachsen, Germany
Apr-22-2014 Electronic Team Lead - HP Analog, Digital, EMC
source:
High Wycombe, Buckinghamshire, United Kingdom
Apr-22-2014 Mechanical Engineer, Valve Design, 3D CAD Job #3846
source:
Mechanical Engineer, Valve Design, 3D CAD Job #3846  Akron, Ohio A local division of a national
Akron, Ohio, United States
Apr-22-2014 Electrical Engineer - Instrumentation
source:
Responsibiities Confer/coordinate with engineers, customers, and others to discuss existing or pote
Houston, Texas, United States
Apr-22-2014 Mechanical Engineer - Germany - Antenna - CAD - Mechanical - RF - Engi
source:
Mechanical Engineers with Antenna design background required in Germany You will be working as a Mec
Bayern, Germany
Apr-22-2014 Subcontracts Administrator
source:
The Subcontracts Administrator must have overall subcontract life cycle experience; the ability to s
Bethesda, Maryland, United States
Apr-22-2014 Director International Research & Product Development - Derivatives -
source:
A leading global player within the global derivatives market is looking to recruit a Director, Resea
London, United Kingdom
Apr-22-2014 Investments Assistant, Sales Analyst Zurich, Switzerland
source:
A US headquartered Institutional Asset Manager, have a vacancy for a Sales and Investments Executive
Switzerland
Apr-22-2014 Regulatory Intelligence Analyst
source:
A Regulatory Intelligence Analyst is required to join the Worlds leading source of intelligent infor
City, London, United Kingdom
Apr-22-2014 Buyside - Hedge Fund, Credit analyst - New Credit business 10bn AUM fu
source:
Leading Hedge Fund seeks talented, ambitious yet down to earth Credit professional. A leading Hedge
London, United Kingdom
Apr-22-2014 Clinical Auditor
source:
The Clinical Auditor (CA) from IMARC Research, Inc. will work with a sponsoring company or CRO in th
Strongsville, Ohio, United States
Apr-22-2014 Business Analyst w/J.D. degree- Multi-State Residential Lending
source:
Third Federal's Multi-State Business Analyst will be responsible for understanding and interpreting
Cleveland, Ohio, United States
Apr-22-2014 Business Development Manager
source:
Business Development Manager selling Research and Analytics services, based in London or t
London, United Kingdom
Apr-22-2014 Lead Middleware Architect
source:
Prestigious Fortune 500 Company is currently seeking a Lead Middleware Architect. Candidate wil
Lincolnshire, Illinois, United States
Apr-22-2014 Senior Network Security Engineer
source:
Prestigious Global Financial Institution seeks a Senior Network Security Engineer.  The success
Chicago, Illinois, United States
Apr-22-2014 Senior IT Security Architect
source:
Prestigious Enterprise Firm is seeking a Security Manager/Architect. This position will be responsib
Illinois, United States