Senior Consultant – Clinical Operations, Development

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

📋 Description

• Oversees or executes designated clinical operations projects, studies, or intricate workstreams.

• Manages allocated clinical studies, projects, or significant workstreams in accordance with approved plans, timelines, budgets, quality standards, and client specifications.

• Provides insights into study and project strategies informed by operational experiences.

• Contributes advanced operational knowledge to protocol development, study design, feasibility assessments, country and site planning, study initiation, enrollment, execution, and closure activities.

• Leads or assists in the creation of clinical documentation, including protocol synopses, protocols, informed consent forms, operational plans, risk assessments, vendor oversight plans, and clinical study reports.

• Supports or directs the selection, onboarding, supervision, performance monitoring, issue resolution, and risk mitigation of vendors and CROs.

• Develops and manages project plans, timelines, budgets, methodologies, dependencies, and status updates.

• Identifies, evaluates, documents, and manages study or project risks while formulating mitigation strategies.

• Aids in the preparation and review of clinical sections for regulatory submissions.

• Leads specific cross-functional workstreams involving Clinical Operations, Regulatory, Quality, Data Management, Medical, Safety, Biometrics, vendors, and other stakeholders.

• Acts as a primary contact for assigned projects or workstreams, communicating status updates, risks, recommendations, and decisions.

• Identifies and applies improvements to study execution, tools, templates, processes, quality, and operational methodologies.

• May lead project teams or defined groups of contributors, providing coaching, technical guidance, feedback, and daily direction.

• Exercises independent judgment in non-routine scenarios and escalates broader business, client, financial, or cross-functional decisions when necessary.

• Contributes Clinical Operations expertise to project scoping, proposals, statements of work, client discussions, and subsequent opportunities.

• Engages in practice development, knowledge sharing, process improvement initiatives, tool or service offering development, and relevant professional or industry activities.

⛳️ Requirements

• Bachelor’s Degree.

• At least twelve years of experience in Clinical Operations within a biotechnology or pharmaceutical environment.

• Proven track record of Clinical Program oversight and Strategic Development Activities.

• Extensive knowledge of current regulatory guidelines, good quality practices (GxPs), legislation, and industry trends.

• Capability to manage multiple priorities and complex issues through logical, creative, analytical, and efficient processes, with a strong emphasis on detail and quality of work.

• Demonstrates sound judgment in selecting methods, techniques, and evaluation criteria for issues that may necessitate comprehensive assessment of variable factors.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Generous paid time off and holiday schedule.

• Opportunities for professional development and continuing education.

• Flexible work arrangements and a collaborative work environment.