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Form of workClinical Data Manager will work 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 SOPs and in compliance with Regenerons data standards. Coordinates, leads and performs clinical data management activities for assigned studies in accordance with Regenerons SOPs and policies and practices.
A typical might include the following:
Serves as primary DM contact for assigned studies, including representation on project teams and
working with CROs performing data management tasks for assigned study.
Coordinates, leads and performs clinical data management activities for assigned studies in accordance
with Regenerons SOPs and policies and practices including, not limited to:
o Monitors data clean-up process performed by CROs from study start-up through data archiving.
o Provides data for analysis.
o 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 in accordance with Regeneron SOPs.
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.
This Job Might Be for You If You:
Have a passion for championing and implementing clinical data platform.
Enjoy working in an innovative and multi-functional team.
Have strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy.
Possess Excellent communication, and project management skills.
To be considered for this role you must have:
Bachelors 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. Previous hematology oncology experience is a plus
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
