Manager, Clinical Trial Safety

About the role

IQVIA is looking for a Manager, Clinical Trial Safety in Madrid. The role is responsible for line management of a group of people and shares accountabilities for delivering high-quality medical data review. It works closely with Study Physicians and Clinical/Project Scientists, providing consolidated data that supports high-quality medical and safety evaluation.

Key responsibilities

• Manage employees through regular meetings, performance development, goal setting, mentoring and coaching, and take part in formal performance and salary reviews
• Ensure compliance with corporate policies, training requirements and reporting obligations (MyTime, financial and quality improvement reporting)
• Recruit, onboard and offboard staff, and build a positive, results-oriented work environment
• Manage SHE risks, incidents, reporting and follow-up in line with the functional and regional strategy
• Lead and support the implementation of strategic initiatives, innovation and best practices
• Provide scientific and operational input to study teams, oversee the review of critical clinical and safety data and ensure its completeness, accuracy and coding consistency
• Share lessons learned across studies and act as a project leader and subject-matter expert for medical/safety data
• Mentor junior staff and lead quality checks on study-level deliverables

Required profile

• Advanced university degree in a medical or life science field
• At least 3 years of experience in clinical research, pharmacovigilance and/or safety and clinical data review, or an equivalent combination of scientific research activities
• Experience in cross-functional pharmaceutical development and proven leadership (people and project) experience
• Line management experience
• Ability to lead complex non-drug projects in a worldwide environment

Required skills

• In-depth understanding of the clinical study and drug development process and GCP/ICH guidelines, including SAE reporting requirements
• Knowledge of procedural documents related to study delivery systems and processes
• Excellent spoken and written English and computer proficiency
• Project management, risk and change management, and stakeholder negotiation