The Senior Manager, Clinical Study Inspection Readiness, is responsible for leading clinical inspection readiness activities to support the Program Operations Leader and Clinical Study Lead(s) for one or more assigned clinical programs within Clinical Trial Management. We believe the Sr. Manager to be responsible for leadership, preparation, and organization for GCP inspections in accordance with ICH/GCP, Regeneron Standard Operating Procedures (SOPs), Work Instructions (WI) and Business Practice Tools (BPT). As the Sr. Manager we assume you will be capable of providing inspection readiness leadership to internally sourced studies and studies outsourced to Clinical Research Organizations (CROs) and serves as the key CTM inspection readiness point of contact. We look for the Sr. Manager to collaborate with the GCP Quality and Inspection Management groups.
A Typical Day May Include:
- Support the Program Operations Leader and Clinical Study Lead(s) in focused leadership, preparation, and organization for GCP inspections with a focus on clinical trial management activities for assigned programs and trials
- Serve as a key point of contact for CTM inspection readiness activities and point person for internal/external team members.
- Interacts closely with the GCP Quality, Development Records Management (DRM) and Inspection Management groups to ensure key CTM actions and deliverables are tracked
- Work with Clinical Study Team (CST) and functional areas to support CTM in providing responses to the Q&A sessions held by Inspection Management for Inspection Readiness, support action item follow up as needed.
- Provide periodic, executive summary updates to CTM Senior Leadership (e.g. Therapeutic Operations Leader, Heads CTM) on status of inspection readiness, risks, and mitigations
- Track and ensure positive Financial Disclosures are reviewed by Regeneron’s Compliance Committee. Support collection and tracking of study Financial Disclosure Forms for applicable Significant Payments of Other Sorts (SPOOS) tracking to support BLA submissions.
This Role May Be For You:
- If you Experience with global agency inspections
- If your have an extensive knowledge of ICH/GCP and current regulatory guidelines/directives, with experience with FDA (BIMO manual), EMA or other regulatory inspections of sponsor, investigator sites, or CROs
- If you can demonstrate interpersonal & leadership skills, with high degree of collaboration
- If you are data driven approach to planning, executing, and problem solving
- If you have technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC
To be considered for this opportunity, we expect you to have 6+ years of Clinical Trial Management experience within a CRO or Pharma/Biotech company.
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)