Temp- Data Management
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.
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). 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 in accordance with Regeneron’s SOP’s and policies and practices including, not limited to:
In this role a typical day may include the following:
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.
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.
Adheres to procedures surrounding retention of data, records, and information for clinical studies
This role might be for you if:
You are passionate about data management and energized by coordinating efforts to deliver phenomenal project documentation.
You have the innate ability to identify areas for process improvement and quickly initiate action plans to resolve them
You are someone who leads by example and inspires staff with follow-through and commitment
To be considered for this opportunity, you must have a minimum of a Bachelor’s 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. We also know that previous oncology and/or ophthalmology experience will assist you greatly, so experience in either field is also preferred. We are looking for an individual who is self-directed and comfortable working in teams with the ability to work and operate independently within a tight deadline environment. A high degree of creativity, latitude and attention to detail is required. Familiarity with all applicable regulations including; CFR, GCP, and ICH Guidelines. Strong analytical and project management skills. Strong written and oral communication skills required. Proficiency appropriate EDC applications and Microsoft Office applications. Software proficiency with CDMS required. Experience with JMP and 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 outstanding 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.