Consultant, Data Management 1 of 2
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.
Under limited supervision, 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 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. Leads and performs clinical data management activities for assigned studies in accordance with Regeneron's SOP's and policies and practices.
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.
• Leads and performs clinical data management tasks for assigned studies in accordance with Regeneron's SOP's and policies and practices including, not limited to:
o Monitors data clean-up process performed by CRO's from study start-up through data archiving.
o Provides data for analysis
o Manages activities including: medical coding; developing data validation checks and managing database snapshot
o 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.
Adheres to procedures surrounding retention of data, records, and information for clinical studies.
Bachelor degree in Mathematics, Science or a related field, along with at least 5 or more years of clinical data management experience in biotechnology, pharmaceutical or health related industry. Previous oncology and/or ophthalmology experience a plus.
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.
o Familiarity with all applicable regulations including; CFR, GCP, and ICH Guidelines. Strong analytical and project mgmt 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.
May report to Director or Above.
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.
Requisition Number: 11639BR