Senior Project Manager

🕒 October 23

🇺🇸 United States – Remote

💵 $140k - $150k / year

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

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This company has sponsored H1B visas in the past.

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Clinilabs

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2000

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Clinilabs is a global, full-service Contract Research Organization (CRO) specializing in the development of central nervous system (CNS) drugs, devices, and technology. The company provides comprehensive services to pharmaceutical, biotechnology, and medtech organizations, supporting their projects from first-in-human to Phase 3 clinical trials. Clinilabs is dedicated to addressing the significant unmet needs in CNS drug development, focusing on neurological, mental health, and substance use disorders.

📋 Description

• Provide accountable leadership for operational delivery of assigned clinical studies from planning and site start-up through execution, close-out, data cleaning, and database lock • Serve as the primary operational contact for sponsors and provide reporting on study status, risks, quality, timelines, budget, and required actions • Translate protocol and contractual requirements into integrated project plans with milestones, dependencies, responsibilities, communication pathways, and escalation thresholds • Lead cross-functional study teams across Clinical Operations, Regulatory, Data Management, Biostatistics, Medical Writing, Pharmacovigilance, Clinical Supplies, Quality Assurance, Finance, Contracts, and Patient Recruitment • Coordinate regional and country-level activities for global studies • Lead country and site feasibility, site selection, activation planning, and essential document readiness • Direct vendor identification, qualification, contracting support, oversight, performance review, and issue resolution • Own study budgets and forecasts; monitor costs, resource utilization, scope, assumptions, and variances • Maintain risk, issue, decision, action, and dependency logs; develop mitigation and contingency plans • Monitor recruitment, enrollment, retention, monitoring, data quality, safety reporting, investigational product supply, and protocol deviations • Ensure study conduct complies with protocols, applicable regulations, ICH/GCP, contracts, and internal SOPs • Review and contribute to protocols, operational plans, study manuals, case report forms, regulatory and site documentation, and investigator meeting materials • Lead preparation for sponsor reviews, audits, and inspections and ensure findings are addressed • Facilitate study team and sponsor governance meetings and track decisions, owners, deadlines, and follow-through • Secure resources and expertise across regions; drive corrective action and recovery planning • Contribute to proposals, bid defenses, study assumptions, timelines, budgets, and operational strategies • Coach, oversee, and mentor Project Managers and project team members • Support process improvement, lessons learned, and scalable project management tools and standards • Attend investigator, sponsor, and internal governance meetings, including outside standard local business hours when needed

🎯 Requirements

• Bachelor's degree in life sciences, nursing, pharmacy, or a related discipline required; advanced degree or recognized project management certification preferred • Typically eight (8) or more years of progressive clinical research experience within a CRO, pharmaceutical, biotechnology, or similar environment, including substantial project management responsibility • Substantial project management experience in CNS clinical trials required • Demonstrated leadership of complex clinical studies from start-up through close-out and database lock, including multi-country or multi-region programs • Demonstrated CNS clinical research experience, including patient recruitment and retention, investigator and site requirements, clinical outcome assessments, and study-specific risks • Strong understanding of the drug development lifecycle • Working knowledge of ICH/GCP and applicable regulatory requirements • Experience identifying country-level operational implications for international studies • Advanced budget ownership, forecasting, resource planning, change-order management, and financial variance analysis skills • Ability to develop integrated project plans, risk and issue management strategies, governance structures, communication plans, and corrective and preventive actions • Executive-level communication, client management, negotiation, influencing, conflict resolution, and decision-making skills • Ability to lead in a matrix environment and manage competing priorities across sponsors, functions, vendors, regions, and sites without direct authority • Proficiency with Microsoft Excel, PowerPoint, Word, Outlook, and project planning or clinical trial management systems • Advanced degree or recognized project management certification preferred

🏖️ Benefits

• Domestic and international travel required based on study and client needs • Flexibility to participate in meetings across global time zones • Coaching, oversight, and mentoring opportunities • Professional development through process improvement initiatives, lessons learned, and scalable tools and standards

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