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 280 jobs posted within 600 days!

Date Description Location
Supplementary Results
Friday
Mar-28-2015 Epidemiologist, AncestryHealth
source:
AncestryHealth () isseeking a self-starting scientist to define and build a corpus ofclinical data t
San Francisco, California, United States
Mar-28-2015 Social Media Web Analyst
source:
Responsibilities: This position is responsible for evaluating, planning, organizing, managing, and
Oak Brook, Illinois, United States
Mar-28-2015 Electrical Engineer (FPGA) - Specialist Prop Trading Firm - Chicago
source:
Electrical Engineer (FPGA) - Chicago Job Description A market leading specialist proprietary trading
Chicago, Illinois, United States
Mar-28-2015 Senior Modem Algorithm Design Specialist
source:
My client is a leading telecoms provider in Europe and they are now looking for a Senior Modem Algor
Lund, Sweden
Mar-28-2015 R&D Chef
source:
Responsibilities: Develop and formulate recipes and new inventive food ideas for fresh salads (grain
Woodbridge, Ontario (ON), Canada
Mar-28-2015 Engineer
source:
Responsibilities: Research and analyze customer design proposals, specifications, manuals to determ
Mossville, Illinois, United States
Mar-28-2015 Manager Financial Analysis
source:
Details: The candidate must have a collaborative management style with the ability to build partner
Deerfield, Illinois, United States
Mar-28-2015 Project Management Assistant - 12-month contract (may convert) (59517)
source:
PROJECT MANAGEMENT ASSISTANT Duration: 12-month contract (W2); may convert to permanent Location: Ho
Honolulu, Hawaii, United States
Mar-28-2015 Network System Analyst (Contracting)
source:
For an international Pharma institution in Basel we are seeking a highly motivated professional to t
Basel, Basel-Stadt, Switzerland
Mar-28-2015 Registered Nurse - Clinical Trials
source:
Registered Nurse with Clinical Trials experience needed! SeaCap Staffing is searching for a Regis
Atlanta, Georgia, United States
Mar-28-2015 Data Center Solutions Architect/Sales Engineer
source:
Data Center Solutions Architect (Madison, WI) compensation: Based on Experience Position Summary: T
Madison, Wisconsin, United States
Mar-28-2015 PPC Account Manager - Digital
source:
PPC Account Manager - Global AgencyIf you are a passionate PPC Account Manager with a desire to work
City, London, United Kingdom
Mar-28-2015 Social Media Executive (or Intern)
source:
Social Media ExecutiveCompany:Nationwide, professional staffing provider experiencing significant gr
Manchester, Lancashire, United Kingdom
Mar-28-2015 Hardware engineer CE compliancy
source:
Hardware engineer CE compliancyLocatie: VenloStart: ZSMDuur: 1000 uur (+- 6 maanden)Project: Het pro
Venlo, Limburg, Netherlands
Mar-28-2015 IT Supporter - 1st and 2nd Level Support for Basel
source:
Edelway AG is a Swiss IT Services Company. On behalf of our global client based in Basel, we are act
Basel, Basel-Stadt, Switzerland
Mar-28-2015 Project Manager - R&D
source:
Milton Keynes, Buckinghamshire, United Kingdom
Mar-28-2015 Purchasing Analyst
source:
Major Job Duties and Responsibilities: Responsible for buying goods and services for use by their c
Mossville, Illinois, United States
Mar-28-2015 Front End Developer
source:
Frontend DeveloperThis is a fantastic opportunity for an Frontend Developer, at a rapidly expanding
Bayern, Germany
Mar-28-2015 IT Systems Engineer
source:
IT Systems Engineer Randstad Professionals is actively looking for IT Systems Engineer Major Account
Basel, Basel-Stadt, Switzerland
Mar-28-2015 BUSINESS ANALYST (Pharma Research, SW development)
source:
Our client, a major Pharma global player is currently looking for a Business Analyst experienced wit
Basel, Basel-Stadt, Switzerland