Senior Manager, Data Management - Clinical Data Standards

Location
Tarrytown, NY, United States
Posted
Apr 07, 2021
Ref
23667BR
Discipline
Clinical, Clinical Data
Required Education
Other
Position 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.
Summary:
Creates and maintains global library of data collection and clinical reports to promote quality and data processing needs by collaborating with Global Development line function representatives as part of Regeneron Data Governance model. Works with clinical project teams to use defined standards and provides guidance for updates to Regeneron global repository. Contributes to establish processes and strategies for data review and collection standards.
Responsibilities:
  • Develop EDC and non-EDC global clinical data standards following CDISC Study Data Tabulation Model (SDTM/CDASH) and controlled terminology
  • Translate clinical study teams reporting needs into specifications and provide custom data review reports solutions
  • Create and maintain data review reports in selected platform (JReview, SpotFire, SAS etc) to include Integrated data, CRF data, eCOA and biomarker data
  • Contribute reports to support the Sponsor oversight of CROs and other data providers by developing targeted reports
  • Communicate and collaborate with multiple line functions to implement standards team strategy
  • May update functional SOPs, Working Procedures and other internal documents
  • Collaborate with training team to deliver custom role based training
  • Update metadata definitions and specifications in an MDR system
  • Contribute reports to support the Sponsor oversight to CROs and other data providers by developing targeted reports
  • Act as an expert on SDTM standards to CROs, vendors and internal REGN teams

Requirements:
  • Adheres to procedures surrounding retention of data, records, and information for clinical studies
  • Complete all assigned Compliance Training on schedule
  • Liason with Medidata Rave to address special needs on reports
  • Coordinate with Medical Monitoring Team and Data Analytics Team to meet business needs
  • Align with the Data Governance Team to ensure data reports meet specification requirements

Advises all direct reports about the procedures surrounding retention of data, records, and information for employees in their group.
Bachelor degree in Mathematics, Science or a related field, along with 5 or more years of clinical data standards or reports management experience in biotechnology, pharmaceutical or health related industry. Previous SAS, RAVE EDC, JReview,SpotFire, Crystal Reports experience a plus
    • Strong experience in report development using main-stream report technologies like JReview, WebIntelligence, Buisness Objects 4, Spotfire, Oracle BI, or Crystal Reports.
    • Strong experience in implementing Industry Standards (e.g. CDISC) in either the collection (CDASH) or tabulation (SDTM)
    • 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.
    • Familiarity with all applicable regulations including; CFR, GCP, and ICH Guidelines. Strong analytical and project mgmt skills. Strong written and oral communication skills required.
    • Proficiency in SQL and scripting with experience in developing advanced queries, stored procedures and views. SAS programming is a plus.
  • Proficient with appropriate RAVE EDC applications and Microsoft Office applications. Software proficiency with CDMS required. Experience with SAS a plus.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.