JOB SUMMARY

 The Senior Project Manager provides end-to-end leadership for complex, multi-country clinical research programs, ensuring sponsor objectives for quality, timelines, budget, risk, and delivery are achieved. The role serves as the primary operational leader and sponsor contact, directing cross-functional teams and external vendors across regions while maintaining compliance with applicable regulations, ICH/GCP, protocol requirements, and company procedures. This position is expected to anticipate issues, drive timely decisions, strengthen global delivery practices, and mentor less-experienced project management staff 

RESPONSIBILITIES

• Provide accountable leadership for the operational delivery of assigned clinical studies, from planning and site start-up through execution, close-out, data cleaning, and database lock, including international studies when assigned.
• Serve as the primary operational contact for the sponsor, establishing effective governance, facilitating decision-making, and providing clear reporting on study status, risks, quality, timelines, budget, and required actions.
• Translate protocol and contractual requirements into an integrated project plan with defined milestones, dependencies, responsibilities, communication pathways, and escalation thresholds.
• Lead and align cross-functional study teams that may include Clinical Operations, Regulatory, Data Management, Biostatistics, Medical Writing, Pharmacovigilance, Clinical Supplies, Quality Assurance, Finance, Contracts, and Patient Recruitment, with particular attention to CNS-specific operational needs.
• Apply prior global study experience to coordinate regional and country-level activities when applicable, recognizing differences in regulatory pathways, site practices, language, culture, time zones, and local operating requirements.
• Lead study start-up strategy, including country and site feasibility, site selection, activation planning, essential document readiness, and mitigation of start-up delays. For CNS studies, consider investigator expertise, patient population access, assessment capabilities, and protocol-specific site requirements.
• Direct vendor identification, qualification, contracting support, oversight, performance review, and issue resolution for outsourced study services.
• Own the study budget and forecast; monitor burn, pass-through costs, resource utilization, scope, assumptions, and variances; initiate timely change-order discussions when scope or delivery requirements change.
• Establish and maintain risk, issue, decision, action, and dependency logs; develop mitigation and contingency plans; escalate material concerns with options and recommendations.
• Monitor recruitment, enrollment, retention, monitoring, data quality, safety reporting, investigational product supply, protocol deviations, and other key delivery indicators in collaboration with functional leads. For CNS studies, provide focused oversight of recruitment challenges, clinical outcome assessment readiness, rater or site training needs, and protocol-specific patient and caregiver considerations.
• Ensure the CRA and site management teams conduct the study in accordance with the protocol, applicable regulations, ICH/GCP, contracts, and internal SOPs.
• Review and contribute to protocols, operational plans, study manuals, case report forms, regulatory and site documentation, investigator meeting materials, and other study-specific deliverables.
• Lead preparation for sponsor reviews, audits, and inspections; ensure identified findings and commitments are addressed within agreed timelines.
• Facilitate cross-functional study team and sponsor governance meetings, including regional participants when applicable, maintaining concise minutes, decisions, owners, deadlines, and follow-through.
• Identify resource constraints or delivery gaps and work with functional leadership to secure appropriate expertise and capacity across regions.
• Drive corrective action and recovery planning when performance is not aligned with the project plan, including clear ownership, dates, and measures of effectiveness.
• Contribute to proposals, bid defenses, study assumptions, timelines, budgets, and operational strategies in response to sponsor Requests for Proposals.
• Provide coaching, oversight, and mentoring to Project Managers and project team members as assigned; promote consistent project management practices and share lessons learned from CNS and international study delivery.
• Support process improvement initiatives, lessons learned, and the development of scalable tools and standards for the project management function.
• Attend investigator meetings, sponsor meetings, and internal governance forums as required, including meetings outside standard local business hours when needed to support global teams.
• Perform other duties as assigned.

LEADERSHIP EXPECTATIONS

• Sets clear direction and creates accountability across a matrixed team that may include geographically dispersed contributors.
• Communicates emerging risks early and brings forward practical, data-informed recommendations.
• Balances sponsor service with quality, compliance, financial stewardship, and realistic delivery commitments.
• Builds trusted working relationships across functions, cultures, regions, and levels of seniority.
• Models ownership, sound judgment, adaptability, and continuous improvement.

  Salary range between $140,000 - $150,000.  Final compensation is based on skills, experience, location, and overall expertise.  

TRAVELING

•  Domestic and international travel is required based on study and client needs.
•  Flexibility to participate in meetings across global time zones is required.
•  Travel frequency will vary by portfolio and should be managed in accordance with company policy.

• 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 is required; experience across multiple CNS indications and development phases is strongly preferred.
• Demonstrated leadership of complex clinical studies from start-up through close-out and database lock, including experience supporting multi-country or multi-region programs.
• Demonstrated CNS clinical research experience, with an understanding of CNS study design and operational considerations, including patient recruitment and retention, investigator and site requirements, clinical outcome assessments, and study-specific risks.
• Strong understanding of the drug development lifecycle, including study start-up, clinical monitoring, data management, biostatistics, medical writing, clinical supply, pharmacovigilance, regulatory activities, and final reporting.
• Working knowledge of ICH/GCP and applicable regulatory requirements. Experience identifying country-level operational implications for international studies and escalating to regional or functional subject matter experts as appropriate.
• Advanced budget ownership, forecasting, resource planning, change-order management, and financial variance analysis skills.
• Demonstrated 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, manage competing priorities, and maintain alignment 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.