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). Works with involved parties to assure that DMM is prepared according to company SOP's and in compliance with Regeneron's data standards. Coordinates, 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.
Coordinates, leads and performs clinical data management activities 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 Coordinates activities including: medical coding; data validation checks and 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
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.
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.
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