Manager, Clinical Trial Inspection Readiness – Actalent

Job title: Manager, Clinical Trial Inspection Readiness

Company: Actalent

Job description: Description:The Senior Manager, Clinical Trial 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

• 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, Clinical Documentation Management Group (CDMG) and Inspection Management groups to ensure key CTM actions and deliverables are tracked
• Work with Clinical Study Team (CST) and functional areas on 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 (readiness/completeness of the CTM inspection readiness tracker, Suspected Non-Compliance reports, Storyboards, TMF Health metrics etc.) and Site Level (overall site level quality conduct such as monitoring frequency, EDC data entry, query resolutions, etc.)
• Provide periodic, executive summary updates to Senior Leadership (e.g. Therapeutic Operations Leader, Heads CTM) on status of inspection readiness, risks, and mitigations
• Perform periodic TMF reviews with key stakeholders to achieve a real-time approach to inspection readiness throughout the trial
• Conduct review and analysis of ongoing Essential Document metrics and quality reports on an ongoing basis to support TMF compliance and action, as needed with CST members
• Track and ensure positive Financial Disclosure’s 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 study teams are following targeted SOPs during study, Business Practice Tools and Working Instructions during the study and provide refresher training to CTM prior to inspections.
• Track inspection readiness meetings, CTM Inspection action items, BIMO questions and answers, storyboards, and presentation requests with key stakeholders (internal/CRO) until closure
• Review Frequently Requested Documents tracker (aka FREDDY document) for completeness and follow up on any missing documents and/or gaps

Additional Skills & Qualifications:Experience in Inspection Readiness from a Clinical Trial Management perspectiveExperience leading clinical inspection readiness activities (FDA/EMA) to support study teams (GCP Audits/Inspections) – this person is the KEY CTM inspection readiness point person

• Interacts with GCP Quality and Inspection Management groups (this person is on the CTM side)
• Experience meeting with stakeholders and aligning expectations and deliverables
• initiate actions coming out of stakeholder meetings and create a plan to address any open action items that were previously identified by stakeholders for all assigned programs

Experience Level:Expert LevelAbout ActalentActalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email for other accommodation options.

Expected salary:

Location: Tarrytown, NY

Job date: Thu, 28 Mar 2024 08:47:07 GMT

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