Clinical Trial Leader

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

📋 Description

• Design, organize, implement, and complete designated clinical trials in alignment with milestones and KPIs.

• Lead and guide both core and extended members of the trial team.

• Oversee patient and site engagement, recruitment strategy, trial feasibility analysis, and risk management.

• Create essential trial and patient-facing documents, integrating feedback from patients and sites.

• Supervise country assignments, vendor management, trial processes, budgets, quality monitoring, safety reporting, and responses to regulatory/ethics inquiries.

• Ensure compliance with trial conduct, GCP standards, regulatory requirements, SOPs, and risk management.

• Track patient recruitment and endpoint achievement, implementing contingency plans as needed.

• Coordinate tasks for early clinical trial Innovation Unit, including biomarker sampling, genomics, and sub-studies.

• Guarantee timely data management, clinical trial reporting, and adherence to TMF archiving standards.

• Assist in the disclosure of results and publication of trial findings.

• Provide operational and scientific insights to enhance trial strategy and feasibility.

• Update stakeholders on trial progress and escalate issues as necessary.

• Collaborate with Clinical Trial Managers and both internal and external stakeholders on a global scale.

⛳️ Requirements

• A university degree is required, ideally a bachelor's or advanced degree focusing on Biomedical Life Sciences.

• Proven experience in managing clinical trial projects.

• Comprehensive understanding of project management and high-performance teamwork dynamics.

• Knowledge of key regulations, including those from the US FDA, EMA, and PMDA.

• Significant experience in clinical trial project management within an international framework.

• Scientific, therapeutic, and operational knowledge related to clinical trial planning and execution.

• Experience in managing complex trials across various protocols, patients, sites, countries, and vendors.

• Excellent communication, active listening, and cultural competency skills.

• Demonstrated leadership, mentoring, coaching, coordination, and oversight abilities.

• Strategic, analytical, results-driven, and globally minded approach.

• Capability to navigate uncertainty, prioritize tasks, manage resources, resolve issues, and take calculated risks.

• Experience in therapeutic areas pertinent to the client pipeline is preferred.

• Familiarity with guidelines and standards of care is a plus.

🏝️ Benefits

• Commitment to equal opportunity employment.

• A global, diverse work environment.

• Opportunities for continuous learning and the sharing of best practices.

• Access to innovative technologies and a culture of empowerment.