Clinical Research Manager - 259764

Key ResponsibilitiesOperational Leadership & Trial ExecutionDirect daily clinical research operations across all active protocols, ensuring studies meet milestones, enrollment targets, and quality benchmarks.Serve as the primary operational liaison with pharmaceutical sponsors, Contract Research Organizations (CROs), and external monitors.Host and lead Site Qualification Visits (SQVs), Site Initiation Visits (SIVs), monitoring visits, and quality audits.Partner directly with Principal Investigators (PIs) and Sub-Investigators to streamline protocol review, patient identification, and clinic-integrated recruitment strategies.Regulatory Compliance & Quality AssuranceOversee site-level regulatory compliance in accordance with FDA regulations, ICH/GCP guidelines, and Institutional Review Board (IRB) requirements.Ensure accurate, timely submission of initial IRB packages, amendments, continuing reviews, safety reports, and close-out documentation.Maintain audit readiness across all active trial binders and electronic regulatory platforms; implement Corrective and Preventive Actions (CAPA) when required.Study Start-Up, Budgeting & FeasibilityEvaluate protocol feasibility, clinical resource requirements, and patient population alignment for incoming study proposals.Collaborate with site administration to review study budgets, Clinical Trial Agreements (CTAs), and billing compliance workflows.Drive cycle-time reductions from initial study feasibility through site activation.Team Supervision & MentorshipSupervise, mentor, and evaluate a dedicated team of Clinical Research Coordinators (CRCs), regulatory specialists, and research support staff.Oversee workload distribution, staff onboarding, GCP training, and continuing protocol-specific education.Foster a collaborative, accountability-driven culture that balances meticulous protocol adherence with compassionate patient care.Candidate QualificationsEducation: Bachelor’s degree in Life Sciences, Nursing, Healthcare Administration, or a related field required. Advanced degree (MS, MPH, or MSN) is an asset.Experience:5+ years of progressive clinical research experience within an outpatient site, hospital network, or academic medical center.2+ years of direct team leadership, supervisory, or clinical research management experience.Trial Experience: Demonstrated track record managing Phase I–IV pharmaceutical clinical trials; experience with medical device or investigational therapeutic protocols preferred.Therapeutic Focus: Prior background in neurology, central nervous system (CNS), or rare diseases is a plus, but candidates with strong multi-therapeutic operational backgrounds are encouraged to apply.Certifications: Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), or Certified Clinical Research Manager (CCRM) through ACRP or SoCRA is strongly preferred.Core Competencies: Advanced knowledge of FDA Title 21 CFR, ICH/GCP guidelines, electronic data capture (EDC) systems, and CTMS/eRegulatory platforms.What Sets This Opportunity ApartDirect Physician Access: Eliminate institutional red tape. You will collaborate directly with deeply engaged physician investigators who consider clinical research fundamental to patient care.True Operational Ownership: Shape trial selection, departmental workflows, and team culture with meaningful executive support and high visibility.Purpose-Driven Pipeline: Lead studies delivering next-generation therapies, advanced neuro-technologies, and investigational compounds to patients with high unmet medical needs.Competitive Compensation & Benefits: Comprehensive compensation package including health/dental/vision coverage, retirement matching, and generous paid time off.