Head of Clinical Operations

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

📋 Description

• Oversee all clinical operations for Resilience-sponsored RCTs, investigator-initiated studies, RWE projects, and collaborations with industry partners.

• Report directly to the Chief Medical Officer.

• Lead a team of five to six Senior CTMs, CTMs, and CRAs.

• Provide operational support on projects when backup is required.

• Ensure studies are delivered on schedule, within budget, and meet quality expectations while managing team workload effectively.

• Offer medical leadership with insight into study timelines, budgets, and risk management.

• Prepare clinical operations for an increasing number of industry partnerships.

• Oversee study budgets, timelines, risk management, GCP compliance, milestones, and performance metrics.

• Conduct weekly reviews and provide reports for all projects.

• Assign projects, designate tasks, organize backup, prioritize workload, and forecast recruitment needs.

• Mentor and develop team members through goal-setting, performance reviews, and coaching.

• Maintain SOPs, templates, and tools; prepare for audits and inspections.

• Serve as the escalation point for sites, investigators, and partners regarding delays, budget issues, and quality concerns.

• Build the operational framework for the clinical research services offered to industry partners, including costing, processes, tools, and staffing.

• Collaborate across multiple functions, including Commercial, Legal, Finance, Clinical Development, Biostatistics, Data Management, Regulatory, Compliance, Market Access, and Product.

⛳️ Requirements

• Manage multiple studies concurrently, including oversight of budgets, timelines, resources, and risks.

• Lead a clinical operations team, balancing workloads while fostering each team member’s autonomy.

• Estimate study costs, create budgets, and oversee financial monitoring.

• Develop and maintain a quality system, including SOPs, templates, and audit preparation, in compliance with GCP, ICH guidelines, the French Jardé law, and GDPR.

• Cultivate relationships with sites, investigators, and industry partners, including managing escalation scenarios.

• Professional proficiency in English, both written and spoken.

• Extensive clinical research expertise, particularly regarding GCP, study budgets, and timelines.

• Strong leadership and decision-making capabilities.

• Possess strategic vision and sound judgment in uncertain situations.

• Effective and structured communication style adaptable to both leadership and operational teams.

• Exceptional interpersonal skills with a collaborative, cross-functional approach.

• Degree in life sciences, pharmacy, clinical research, or biomedical engineering—MSc, MD, PharmD, or PhD.

• Minimum of eight years’ experience in clinical research, including three years in a leadership role or managing a study portfolio.

• Proven experience leading studies for sponsors or industry partners in a CRO, pharmaceutical, biotech, or medtech setting.

• Ideally, experience with real-world studies or medical devices.

• Familiarity with ISO 14155 is advantageous.

🏝️ Benefits

• Work fully remotely from France.

• Regular travel associated with the role.

• Opportunity to lead clinical operations at a dynamic medtech company.

• Chance to influence the organization, processes, and tools of the team.

• Opportunity to contribute to the development of the clinical research services for industry partners.

• Opportunity to engage in studies that integrate clinical research, digital tools, and patient-centered follow-up across various therapeutic areas.