The Sr. Manager, Clinical Data Management Processes, Quality, and Inspections with lead and perform Clinical Data Management (CDM) process quality oversight including CAPA management, audits and inspections. Responsible for assisting study data managers to work through and resolve process issues that have the potential to impact compliance or data integrity. Performs investigations and problem solving activities to ensure on time CAPA completion and effectiveness checking. Works extensively with partner QA/GCP Compliance functions and relevant clinical study teams to support problem solving, preparations for audits and inspections as well as responses for requests/questions during audits/inspections. Supports implementation of CDM process improvements related to inspection readiness or as a consequence of CAPAs.
In this role, a typical day might include the following:
Respond to CDM process and quality related questions
Lead study-level Inspection Readiness activities, build documentation for SOP Deviations and other Quality Events that occur
Perform or follow-up with co-workers performing CDM-related CAPA actions to ensure timely completion
Provide mentorship to data managers when preparing for an audit, inspection, or handling an issue related to process quality/compliance
Assist in the performance of Root Cause Analysis and drafting of appropriate CAPAs.
Participate in process improvement and training initiatives within CDM and other clinical drug development functions.
This role may be for you if:
You have a strong Clinical Data Management background and a quality/process focus
You establish and maintain partner relationships with colleagues in other line functions including QA/GCP Compliance, Clinical, and Biostatistics.
You help drive inspection readiness by providing teams with support to resolve obstacles to process adherence and support for improvement of process training materials when gaps are identified
Support the improvement in quality within CDM by identifying and addressing areas of concern from audit/inspection findings.
Assist the DM Leadership Team to drive data quality, compliance and quality process improvement within the department and neighboring functions.
To be considered for this opportunity:
We seek a Bachelor degree in Life Sciences, Mathematics, Computer Science, Medical Informatics or equivalent degree. Must have least 5 or more years of clinical data management experience or a related functional area (i.e., Biostatistics, Clinical Sciences, or Site Monitoring). Familiarity with applicable regulations including CFR, GCP, and ICH Guidelines. Previous experience supporting audits and inspections is 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)
$126,600.00 - $206,600.00