Clinical Trial Leader – FSP

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

📋 Description

• Oversee the establishment, execution, delivery, and conclusion of assigned clinical trials

• Provide leadership and guidance to both core and extended team members involved in trials

• Plan, implement, monitor, and manage clinical trial activities, including risk mitigation strategies

• Lead preparations for trials, assess operational feasibility, plan recruitment strategies, develop engagement plans, and create patient-facing documents

• Supervise country allocations, trial feasibility assessments, vendor services, trial processes, budgets, quality monitoring, safety reporting, and responses to regulatory/ethics inquiries

• Maintain oversight of trial conduct, ensuring compliance with GCP, regulatory standards, SOPs, and ongoing risk assessments

• Track patient recruitment and endpoint accrual, implementing contingency plans as necessary

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

• Ensure prompt clinical data cleaning, delivery, archiving in the TMF, and disclosure of results/documents

• Facilitate and assist in the preparation of Clinical Trial Reports

• Support trial strategy development, milestone planning, operational and scientific contributions, and regulatory communications

• Update stakeholders on trial status and escalate issues when necessary

• Collaborate with Clinical Trial Managers and both internal and external stakeholders globally across various countries or regions

⛳️ Requirements

• Robust experience in clinical trial project management

• Comprehensive understanding of project management, focusing on teamwork and high-performance teams

• Experience in oncology and/or inflammation is preferred

• Familiarity with key regulations such as US FDA, EMA, and PMDA

• Knowledge of guidelines and standard care practices is an advantage

• Experience working across geographical boundaries and understanding multicultural and cross-cultural dynamics

• Strong skills in mentoring and coaching

• Proven ability to demonstrate agility, accountability, intrapreneurship, quick decision-making, flexibility, ownership, outcome-based thinking, results orientation, and prudent risk-taking

• Excellent communication, active listening, and cultural awareness skills

• Scientific and therapeutic knowledge coupled with operational expertise in clinical trial planning and execution

• Extensive experience in managing international clinical trial projects

• Capability to lead and influence in complex situations

• Strategic, visionary, creative, courageous, and analytical mindset

• Skill in setting priorities, managing the pace of activities, and utilizing resources effectively

• Proficient in project planning, prioritization, action definition, transparency, and clarity

• University degree, such as a bachelor’s or advanced degree, with a major focus in Biomedical Life Sciences

🏝️ Benefits

• Equal opportunity employer

• Global, multicultural work environment

• Opportunities for mentoring/coaching and professional development through leadership and team collaboration