Senior Consultant – Clinical Operations, Development

ProductLife Group

. Leads or delivers defined clinical operations projects, studies, or complex workstreams .

Posted 11/2/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Clinical Operations, including project management, regulatory compliance, and strategic development within biotechnology or pharmaceutical settings. Proficient in leading cross-functional teams, managing clinical studies, and implementing process improvements to enhance study execution and quality.

Highest-signal resume keywords

Clinical Operations ManagementRegulatory ComplianceProject ManagementClinical Program OversightStrategic Development Activities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study DesignProtocol DevelopmentRisk AssessmentVendor OversightBudget ManagementTimeline ManagementFeasibility AssessmentEnrollment ManagementClinical DocumentationRegulatory Submissions

Soft Skills

Attention to DetailAnalytical ThinkingCreative Problem SolvingEffective CommunicationJudgment and Decision Making

Industry Keywords

Good Quality Practices (GxPs)BiotechnologyPharmaceuticalClinical OperationsCross-Functional CollaborationProcess ImprovementStudy Start-UpStudy CloseoutPerformance MonitoringIssue Resolution

About the role

Key responsibilities & impact

Leads or delivers defined clinical operations projects, studies, or complex workstreams
Manages assigned clinical studies, projects, or major workstreams against approved plans, timelines, budgets, quality expectations, and client requirements
Provides input into study and project strategy based on operational experience
Contributes advanced operational expertise to protocol development, study design, feasibility assessment, country and site planning, study start-up, enrollment, conduct, and closeout activities
Leads or contributes to clinical documentation including protocol synopses, protocols, informed consent forms, operational plans, risk assessments, vendor oversight plans, and clinical study reports
Supports or leads vendor and CRO selection, onboarding, oversight, performance monitoring, issue resolution, and risk mitigation
Develops and manages project plans, timelines, budgets, methodologies, dependencies, and status reporting
Identifies, assesses, documents, and manages study or project risks and develops mitigation plans
Supports preparation and review of clinical sections of regulatory submissions
Leads defined cross-functional workstreams across Clinical Operations, Regulatory, Quality, Data Management, Medical, Safety, Biometrics, vendors, and other contributors
Serves as a key contact for assigned projects or workstreams and communicates status, risks, recommendations, and decisions
Identifies and implements improvements to study execution, tools, templates, processes, quality, and ways of working
May lead project teams or defined groups of contributors and provide coaching, technical guidance, feedback, and day-to-day direction
Exercises independent judgment in non-routine situations and escalates broader business, client, financial, or cross-functional decisions
Contributes Clinical Operations expertise to project scoping, proposals, statements of work, client discussions, and follow-on opportunities
Participates in practice development, knowledge sharing, process-improvement initiatives, tool or service offering development, and relevant professional or industry activities

Requirements

What you’ll need

Bachelor’s Degree
Minimum of twelve years of experience in Clinical Operations in a biotechnology or pharmaceutical setting
Demonstrated history of Clinical Program oversight and Strategic Development Activities
Deep familiarity with current regulatory guidance, good quality practices (GxPs), legislation, and industry trends
Ability to balance multiple priorities and sophisticated issues using logical, creative, analytical, and efficient processes with a high level of attention to detail and quality of work
Exercise good judgment in selection methods, techniques and evaluation criteria for issues that may require in-depth evaluation of variable factors