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 213 jobs posted within 1600 days!

Date Description Location
Supplementary Results
Saturday
Mar-26-2017 Clinical Scientist
source:
Clinical Scientist with profound research and reviewing experience wanted for our Basel based client
Basel, Switzerland
Mar-26-2017 JIRA Consultant
source:
We are hiring for JIRA Consultant at Den Haag, Netherlands for one our reputed client. Job Title: JI
Den Haag, Zuid-Holland, Netherlands
Mar-26-2017 Client Services Executive
source:
Client Service Executive Market Research, TV - Central London, The Role We are looking for a Client
City, London, United Kingdom
Mar-26-2017 RN/LPN Research Coordinator
source:
Busy dedicated clinical research site located in Norfolk, VA is looking for a detail oriented RN or
Norfolk, Virginia, United States
Mar-26-2017 Senior Splunk Engineer
source:
Overview: Seeking a Senior Splunk Engineer Well known company in Charlotte, NC seeking a Senior Spl
Charlotte, North Carolina, United States
Mar-26-2017 Account Acquisition Specialist
source:
The Account Acquisition Specialist​ will report directly to the Director of Distribution. The
Lebanon, Pennsylvania, United States
Mar-26-2017 F5 Network Engineer
source:
Overview: Seeking an F5 Network Engineer Well known company in Chicago, IL also open to Irving, TX a
Charlotte, North Carolina, United States
Mar-26-2017 (Senior) Backend Entwickler PHP (m/w)
source:
Hamburg, Deutschland
Mar-26-2017 Manager Software Engineering (f/m)
source:
Manager Software Engineering (f/m) Dreamlines is an innovative and fast growing online travel bus
Hamburg, Germany
Friday
Mar-25-2017 Systems Support Analyst
source:
Based in Covent Garden, City Lit is London's largest provider of learning for adults, inspiring ove
London, United Kingdom
Mar-25-2017 HR Advisor - HR Support
source:
HR Advisor - HR Support Prestigious London based client requires an accomplished HR Advisor who has
London, United Kingdom
Mar-25-2017
source:
Cirencester, Gloucestershire, United Kingdom
Mar-25-2017 Supported Employment Specialist
source:
Are you a recovery-oriented individual that is hopeful about every person's ability to succeed? Are
Mentor, Ohio, United States
Mar-25-2017 Administrative Specialist
source:
Company Profile Talis Clinical, LLC provides health technology supporting clinicians to impact patie
Streetsboro, Ohio, United States
Mar-25-2017 System Protection Relay Engineer
source:
Salary: $72,800 - $93,600SYSTEM PROTECTION/RELAY ENGINEER - PORTLAND OR or SEATTLE WASupervise/perfo
Seattle, Washington, United States
Mar-25-2017 Product Manager (Agile)
source:
Product Manager (Agile) Are you a product manager that enjoys working in an agile environment and
Atlanta, Georgia, United States
Mar-25-2017 International Clinical Trial Manager
source:
International Clinical Trial Manager - Basel - 100% If you are a Clinical Trial Manager, then you ar
Basel, Switzerland
Mar-25-2017 SCADA Systems Administrator
source:
Our direct clent in Omaha is looking for a SCADA Systems Administrator to support their SCADA infras
Omaha, Nebraska, United States
Mar-25-2017 ERP Administrator - PICK
source:
Salary: $65,000 - $75,000Job Summary: The ERP administrator is responsible for the maintenance and c
Syracuse, New York, United States
Mar-25-2017 Director of Art - Gaming
source:
Responsibilities:*Provide artistic leadership and lead team to drive the overall vision of the proje
China