Manager, Data Management - Clinical Data Standards
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Tarrytown, NY, United States
- Start date
- Sep 13, 2019
View more
- Discipline
- Clinical, Clinical Data
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
Responsibilities:
Hands on experience developing operational (3rd party and EDC) global clinical data standards following CDISC Study Data Tabulation Model (SDTM/CDASH) and controlled terminology
• Work with external vendors/organizations to develop best practices and advance REGN clinical data standards
• Standardize vendor/3rd party data collection
• Participate in relevant governance team meetings and provide standards input as assigned
• Act as an expert on SDTM standards to CROs, vendors and internal REGN teams.
• Communicate and collaborate with multiple line functions to implement standards team strategy
• May update functional SOPs, working Procedures and other internal documents
• Identify and propose process improvements from CDISC/SDTM/CDASH standards perspective
• Provide guidance to study teams on creating eCRFs to support clinical database set up
• Develop and deliver training for REGN standards related processes
• Update metadata definitions and specifications in an MDR system
Requirements:
• BA/BS in health sciences or computer science discipline. Minimum 5 years working experience in clinical data management, clinical data conversion or clinical data programming. Submission experience is a plus.
• End to end knowledge of drug development process
• Strong understanding of FDA/ICH guidelines for clinical study data
• Should be able to work effectively as a member of multi-functional teams across programming, biostatistics, data management and clinical sciences
• EDC build (Rave) experience a plus
• Strong experience in implementing Industry Standards (e.g. SDTM CDISC) in either the collection (CDASH) or tabulation (SDTM)
• Project management and strong communication skills
• Previous experience with an MDR system
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Company
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Website
- https://www.regeneron.com/
- Phone
- 914-847-7000
- Location
-
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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