If you are looking for an uncommon opportunity -- a chance to join an organization known for its scientific excellence in the research and development of pharmaceuticals -- it's time to consider Regeneron.
Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets three products in the United States, EYLEA® (aflibercept) Injection, ZALTRAP® (ziv-aflibercept) Injection for Intravenous Infusion, and ARCALYST® (rilonacept) Injection for Subcutaneous Use; ZALTRAP is co-commercialized with Sanofi. Phase 3 studies are in progress with EYLEA in two additional indications and with product candidates sarilumab and REGN727. Regeneron has active research and development programs in many disease areas, including ophthalmology, inflammation, cancer, and hypercholesterolemia.
- Works collaboratively with vendor Project Managers and Clinical Data Managers to assure that Data Management functions are performed in compliance with regulations and according to study protocol and the Study Data Management Manual (DMM).
- Works with involved parties to assure that DMM is prepared according to company SOP’s and in compliance with Regeneron’s data standards.
- Coordinates leads and performs clinical data management activities for assigned studies in accordance with Regeneron SOP’s and policies and practices.
Essential Duties and Responsibilities include , but are not limited to the following:
- Serves as primary DM contact for assigned studies, including representation on project teams and working with CRO’s performing data management tasks for assigned study.
- Coordinates, leads and performs clinical data management activities for assigned studies in accordance with Regeneron SOP’s and policies and practices including, not limited to:
- Monitors data clean-up process performed by CRO’s from study start-up through data archiving.
- Provides data for analysis
- Coordinates activities including: medical coding; data validation checks and database snapshot
- Prepares and distributes project status reports to project team and management.
- Functions as DM team leader responsible for ensuring databases are validated and ready for transfer and/or analyses in accordance with Regeneron SOP’s.
- Creates and maintains project documentation, including, but not limited to, Data Management Manual, CRF Completion Guidelines and validation specifications, and work instructions for assigned projects. Designs and modifies CRF.
- Responsible for the initiation and approval of the building, testing and validation of clinical databases, subsequent changes in clinical databases and data validation activities.
- Contributes to upkeep Regeneron DM outsourcing strategies and long-term relationships with outsourcing partners with objective of ensuring data quality and efficiencies through data and process standardization.
- Works with study team and coordinates all data management functions. Manages coordination of CRO data manager and project team to ensure that tasks are performed according to policies and procedures.
Education and Experience:
- Bachelor degree in Mathematics, Science or a related field, along with 3 or more years of clinical data management experience in biotechnology, pharmaceutical or health related industry.
- Previous oncology and/or ophthalmology experience a plus.
Knowledge and Specialized Skills:
- Familiarity with all applicable regulations including; CFR, GCP, and ICH Guidelines.
- Strong analytical and project management skills.
- Strong written and oral communication skills required.
- Proficient with appropriate EDC applications and Microsoft Office applications.
- Software proficiency with CDMS required.
- Experience with JMP and SAS a plus.
We offer a competitive compensation and benefits package including stock incentives, 401k with company match as well as the expected health and welfare benefits. Comprehensive relocation benefits are available, as required.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply to us today and find out what we mean when we say that, at Regeneron, we have an unwavering commitment to combining good science & good business.
Regeneron is not accepting unsolicited assistance from search firms/employment agencies for this employment opportunity. 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 without a valid written search firm agreement in place for this position will be deemed the sole property of Regeneron. No fee will be paid in the event the candidate is hired by Regeneron as a result of the referral or through other means. Moving forward, Regeneron is using the agency management company, Candex - www.candex.com
ARCALYST, EYLEA, and ZALTRAP are trademarks of Regeneron Pharmaceuticals, Inc.
To apply for this position, please CLICK HERE