Manager/ Sr. Manager - Data Management

Jul 17, 2017
Jul 19, 2017
Employer Type
Direct Employer
Employment Type
Full Time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

The Biostatistics and Data Management group inside the Global Clinical Development organization is looking for a Manger/Senior Manager Data Management. This person provides oversight of lead Data Manager(s) on assigned clinical data management projects in multiple therapeutic areas to assure proper planning and execution for data management deliverables that meet Regeneron standards and within timelines. Ensures training for direct reports that have adequate data management skills and are in compliance with all regulatory requirements. Coordinate with Director or Associate Director of Data Management in the development of SOPs, Working Practice, Data Management Manual, and other data management standards.

  • Serves as primary DM contact for assigned therapeutic areas to interact with clinical counterparts for overall project planning and issue resolution. Projects, allocates and prioritizes DM resources within the assigned therapeutic projects.
  • Supervises and ensures all databases are developed, validated and ready for transfer and/or analysis according to policies and procedures, SOPs and work instructions in compliance with applicable regulations.
  • Advises all direct reports about the procedures surrounding retention of data, records, and information for employees in their group.
This position requires a minimum of a Bachelor degree in Mathematics, Science or a related field, along with at least 6-8 or more years of clinical data management experience in biotech, pharmaceutical or health related industry. Previous oncology and/or ophthalmology experience a plus. Previous managerial experience is preferred. Strength in DM process and DM project management is a must. Other requirements include:
  • Knowledge of all applicable regulations including; CFR, GCP, and ICH Guidelines. Strong communication, leadership and business development skills required.
  • Leads by example and manages staff by commitment. Self-directed and comfortable working in teams with the ability to work and operate independently within a tight deadline environment. High degree of creativity, latitude and attention to detail required
  • Proficient with appropriate EDC applications and Microsoft Office applications. Software proficiency with CDMS required. Experience with JMP and SAS a plus.
Level will be commensurate with experience

Your resume may be reviewed for consideration as new opportunities arise within Regeneron. Please note, this is not a current open position and this information is subject to change. We encourage you to create an applicant profile and set up job "alerts" so you may receive notification when specific jobs are posted to the respected department. Please understand that we may not respond to your application.

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 Regenerons 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.