Sr. Clinical Trial Manager - Hybrid

Sr. Clinical Trial Manager - Hybrid Primary Location: Maple Grove, Minnesota Education And Experience Bachelor’s degree in a scientific or healthcare discipline; advanced degree preferred. Experienced in: Renal denervation, Clinical trial management, People management of clinical trials and Cardiology Clinical trials. 10 years of experience in clinical research, including global clinical trials and vendor management. 5 years of demonstrated leadership experience managing and developing clinical trial staff, preferred. Strong understanding of GCP, ICH guidelines, and global regulatory requirements. Proven ability to manage complex timelines, budgets, and cross functional deliverables. Excellent communication, negotiation, and stakeholder management skills. Ability to navigate ambiguity, drive decision making, and influence across levels of the organization. Proven exposure and experience to internal audits and regulatory body audits. Ability to work in fast‑paced environment requiring support of multiple studies and direct reports simultaneously. Job Responsibilities Lead, mentor, and develop Clinical Trial Managers and other assigned study personnel, fostering a high-performance, collaborative team environment. Lead proactive risk identification, mitigation planning, and contingency management across assigned studies. Oversee end-to-end operational execution of global clinical trials, ensuring adherence to protocol, GCP, SOPs, and applicable regulatory requirements. Translate program strategy into operational plans, timelines, and resource needs; ensure cross-functional alignment and timely delivery of study milestones. Manage CROs and external vendors, including selection, contracting, performance oversight, issue escalation, and budget tracking. Oversee development and maintenance of study documentation, including operational plans, study materials, systems, and regulatory submissions. Provide clear, data‑driven study updates, risk assessments, and recommendations to clinical leadership and governance bodies. Manage clinical trial budgets, including forecasting, accruals, variance analysis, and financial oversight of vendor contracts. Build and maintain strong relationships with investigators, clinical sites, and key opinion leaders to support enrollment, engagement, and study success. Champion continuous improvement in clinical operations processes, tools, and best practices. Ensure inspection readiness and compliance with internal quality standards, audit findings, and regulatory expectations. Qualified candidates should send their resumes to View email address on click.appcast.io . V-Soft Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. #J-18808-Ljbffr