Senior Manager Clinical Study Inspection Readiness

The Senior Manager, Clinical Study Inspection Readiness, leads all Good Clinical Practice (GCP) inspection readiness activities for one or more assigned clinical programs within Clinical Trial Management (CTM). Reporting to senior leadership and partnering closely with Program Operations Leaders (POLs) and Clinical Study Leads (CSLs), this role owns the preparation, organization, and execution of inspection readiness strategy in accordance with International Council for Harmonization (ICH)/GCP guidelines, Regeneron Standard Operating Procedures (SOPs), Work Instructions (WIs), and Business Practice Tools (BPTs). The role provides inspection readiness leadership across both internally sourced studies and those outsourced to Clinical Research Organizations (CROs), serving as the primary CTM point of contact for all inspection-related activities. This role is expected to leverage Artificial Intelligence (AI)-powered tools — including large language model (LLM) applications such as Claude — to accelerate deliverable production, strengthen documentation quality, and drive continuous improvement in inspection readiness operations, with all AI-assisted outputs subject to human review and full GCP compliance

A typical day in this role looks like:

Serve as:

• CTM Inspection Readiness point of contact leading GCP inspection readiness programs across complex, multi-program clinical portfolios involving both internal teams including CRO partners, and Inspection Management.
• Project manager during the inspection process (mock, dry run and/or actual) and assist, and/or lead (as needed) the CTM team with follow up requests from the inspector/inspection management team during mock and actual inspection(s).

Provide guidance and support to Clinical Trial Management as follows:

• 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.
• Support ongoing CTM activities related to TMF health and oversight
• Provide guidance on compliance and regulations and ensure CTM staff study teams are following targeted SOPs during study, Business Practice Tools and Working Instructions during the study
• Track inspection readiness meetings, CTM Inspection action items, questions and answers, storyboards, and presentation requests with key stakeholders (internal/CRO) until closure
• Manage CTM inspection action items throughout the inspection lifecycle, from pre-inspection activities (readiness meetings, Q&As, storyboards, presentation requests with internal/CRO stakeholders) to post-inspection tasks (remediation plans, timelines, documentation, closure updates), ensuring prompt resolution and a complete audit trail.
• Support the CTM processes related to Inspection Readiness to ensure that appropriate documentation is produced/maintained in the TMF, including frequently requested documents and early identification of Sites of Interest (SOI).
• Work with the Clinical Study Leads, CRO and/or Vendor team(s) to obtain all the necessary essential and regulatory documents for all study/sites as part of the IRR activities.
• Track CTM action items assigned following inspections to ensure action plans are in place for remediation, as needed, with timelines for completion. Ensure supportive documentation is available to support resolution of the action items and provides updates to as needed on the resolution
• May lead and participate in internal process improvement projects/initiatives to continuously improve operational excellence to support inspection readiness
• Utilize AI-powered applications (e.g., Claude, Microsoft Copilot) to draft, refine, and quality-check executive summaries, inspection storyboards, response documents, and Corrective and Preventive Action (CAPA) narratives, TMF gap analysis, action item tracking, and executive communication.
• Establishing goals, expectations, and accountabilities for direct reports. Regularly reviews performance in respect to quality and timeliness standards according to Regeneron SOPs and working procedures.
• Responsible for coaching, managing training and leading the direct reports.
• May require up to 25% travel

In order to be considered qualified for this role, a minimum of a BS/BA Degree and 8+years relevant clinical experience. Clinical Inspection experience heavily preferred.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

 

Where necessary, we disclose salary ranges for roles in all countries in which we operate.  The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.  Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.  If you have any questions, please speak with your recruiter. 

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$150,500.00 - $245,500.00