The Sr. Mgr., 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.
The role is 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). This role will provide inspection readiness leadership to internally sourced studies and studies outsourced to Clinical Research Organizations (CROs) and serves as the key CTM inspection readiness point person for internal/external team members. This role interacts closely with the GCP Quality and Inspection Management groups.
A typical day may include:
- 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.
- Lead weekly/biweekly inspection preparation meetings with CTM with a focus on Inspection Preparation at the Study Level
- Provide periodic, executive summary updates to CTM Senior Leadership (e.g. Therapeutic Operations Leader, Heads CTM) on status of inspection readiness, risks, and mitigations
- Support ongoing CTM activities related to TMF health and oversight
- Conduct review and analysis of ongoing Essential Document metrics and quality reports on an ongoing basis to support CTM in managing TMF compliance and action, as needed with CST members
- 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.
- 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 collaborators (internal/CRO) until closure
- Work with internal study team and/or CRO to ensure our key Site of Interest (SOI) sites are prepared for potential audits (study files complete, open actions closed out, all deviations reported, etc). Assist with follow up of any action items from the REGN visits as part of the inspection readiness activities.
- 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 with DRM.
- Support the collection and review of CTM led staging room documents and pre-requested documents in preparation for mock/actual inspections.
- Attend the mock and actual inspection and act as a project manager during the inspection process and assist the CTM team with follow-up requests from the inspector/inspection management team In presence attendance during all inspections is required unless otherwise indicated by Senior Leadership.
- 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
- Support CTM-managed activities to ensure vendor preparations (imaging, IRT, labs) for potential inspections
- For the actual site inspections by FDA/EMA, etc at our sites, assist with the follow up on urgent requests that needed CSL support
- May require up to 25% travel
location: Tarrytown, New York
job type: Contract
salary: $87 - 103 per hour
work hours: 9 to 5
This role may be for you if:
- Experience with global agency inspections
- Extensive knowledge in research & development with experience in global clinical trial operations including experience developing protocols and key study documents
- Strong 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
- Quality focused with effective project management skills, cross-functional team leadership and organizational skill
- Proven interpersonal & leadership skills, with high degree of collaboration
- A data driven approach to planning, executing, and problem solving
- Effective interpersonal skills via verbal, written and presentation abilities
- Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization. Ability to influence and negotiate
- 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, you have a Bachelor's degree and minimum of 8 years relevant industry experience.
This is a contract position at Regeneron with Magnit Global being the Employer.
W2 only, no third party solicitation
To do our best work we need different viewpoints. Therefore, we celebrate diversity and embrace inclusion. As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills. We strive to ensure that we maintain a positive and enriching work environment for all.
QUALIFICATION/ LICENSURE :
- Work Authorization : Green Card, US Citizen
- Preferred Years of Experience : 8+ years
- Travel required : 25% or less
- Shift timings: 9 AM to 5 PM
skills: Clinical Study Design
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.