Senior Project Manager

Clinilabs

. 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 .

Posted 10/23/2026full-timeRemote • United StatesSenior💰 $140,000 - $150,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive project management expertise in clinical research, particularly in CNS clinical trials, with a strong focus on budget ownership, risk management, and compliance with ICH/GCP regulations. Proven ability to lead cross-functional teams and manage complex studies from planning through execution and close-out.

Highest-signal resume keywords

CNS Clinical Trials ManagementProject Management CertificationBudget Ownership and ForecastingICH/GCP ComplianceCross-Functional Team Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research ExperienceIntegrated Project PlanningRisk and Issue ManagementData Quality MonitoringPatient Recruitment and Retention

Soft Skills

Executive-Level CommunicationNegotiation SkillsConflict ResolutionDecision-Making SkillsInfluencing Skills

Tools & Technologies

Clinical Trial Management SystemsMicrosoft ExcelMicrosoft PowerPointMicrosoft WordMicrosoft Outlook

Certifications & Qualifications

Project Management CertificationAdvanced Degree in Life Sciences

Industry Keywords

Clinical OperationsDrug Development LifecycleRegulatory RequirementsVendor ManagementStudy Feasibility and Activation

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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