Under limited supervision, the Senior Data Manager 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, policies and practices.
In this role, a typical day might include 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.
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:
Monitors data clean-up process performed by CRO’s from study start-up through data archiving.
Provides data for analysis o Manages activities including: medical coding; developing data validation checks and managing 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
This role may be for you if you have experience:
Creating and maintaining 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.
To be considered for this opportunity you will need:
Bachelor Degree in Mathematics, Science or a related field 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.
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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)