Senior Project Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver accountable leadership for the operational execution of assigned clinical studies, covering all phases from planning and site initiation to execution, close-out, data cleaning, and database lock.

• Act as the main operational liaison for sponsors, providing updates on study status, risks, quality, timelines, budget, and necessary actions.

• Convert protocol and contractual requirements into comprehensive project plans that include milestones, dependencies, responsibilities, communication pathways, and escalation thresholds.

• Guide cross-functional study teams spanning Clinical Operations, Regulatory, Data Management, Biostatistics, Medical Writing, Pharmacovigilance, Clinical Supplies, Quality Assurance, Finance, Contracts, and Patient Recruitment.

• Oversee regional and country-specific activities for global studies.

• Lead country and site feasibility assessments, site selection, activation planning, and preparation of essential documents.

• Manage vendor identification, qualification, contracting support, oversight, performance evaluation, and issue resolution.

• Take ownership of study budgets and forecasts, keeping track of costs, resource utilization, scope, assumptions, and variances.

• Maintain logs for risks, issues, decisions, actions, and dependencies while developing mitigation and contingency plans.

• Supervise recruitment, enrollment, retention, monitoring, data quality, safety reporting, investigational product supply, and protocol deviations.

• Ensure compliance with study 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 materials for investigator meetings.

• Direct the preparation for sponsor reviews, audits, and inspections, ensuring that findings are addressed promptly.

• Facilitate governance meetings with study teams and sponsors, tracking decisions, owners, deadlines, and follow-through actions.

• Secure necessary resources and expertise across regions, driving corrective actions and recovery plans.

• Assist in drafting proposals, bid defenses, study assumptions, timelines, budgets, and operational strategies.

• Mentor, oversee, and coach Project Managers and project team members.

• Promote process improvement, incorporate lessons learned, and develop scalable project management tools and standards.

• Attend meetings with investigators, sponsors, and internal governance, including those outside standard local business hours as required.

⛳️ Requirements

• A Bachelor's degree in life sciences, nursing, pharmacy, or a related field is required; an advanced degree or recognized project management certification is preferred.

• Typically, eight (8) or more years of progressive clinical research experience within a CRO, pharmaceutical, biotechnology, or similar environment, with significant project management responsibilities.

• Extensive project management experience in CNS clinical trials is essential.

• Proven leadership in managing complex clinical studies from start-up through close-out and database lock, including multi-country or multi-region programs.

• Documented CNS clinical research experience, including patient recruitment and retention, investigator and site requirements, clinical outcome assessments, and study-specific risks.

• Strong comprehension of the drug development lifecycle.

• Familiarity with ICH/GCP and relevant regulatory requirements.

• Experience in identifying country-level operational implications for international studies.

• Advanced skills in budget ownership, forecasting, resource planning, change-order management, and financial variance analysis.

• Capability to create integrated project plans, risk and issue management strategies, governance structures, communication plans, and corrective and preventive actions.

• Excellent executive-level communication, client management, negotiation, influencing, conflict resolution, and decision-making skills.

• Ability to lead in a matrix environment and handle competing priorities across sponsors, functions, vendors, regions, and sites without direct authority.

• Proficiency in Microsoft Excel, PowerPoint, Word, Outlook, and project planning or clinical trial management systems.

• An advanced degree or recognized project management certification is preferred.

🏝️ Benefits

• Domestic and international travel is required based on study and client needs.

• Flexibility to engage in meetings across global time zones.

• Opportunities for coaching, oversight, and mentoring.

• Professional development through process improvement initiatives, lessons learned, and scalable tools and standards.