Study Start Up Manager - Biotech

About the role

IQVIA Biotech is looking for a Study Start Up Manager in Lisbon to lead the strategic planning and execution of site activation and maintenance across complex, global clinical studies and multi-protocol programs. The role suits a seasoned clinical research professional who enjoys regulatory strategy, site activation and leading high-performing teams in a fast-paced, international environment.

Key responsibilities

• Lead and oversee global site activation and maintenance for assigned clinical studies and programs
• Develop and execute regulatory and site activation strategies to ensure timely study start-up and ongoing compliance
• Partner with cross-functional study teams, clients and country/regional stakeholders to reach project milestones
• Provide regulatory guidance and intelligence for business development, bid defense and study execution
• Manage project scope, timelines, budgets, resources and quality standards throughout the study lifecycle
• Identify regulatory risks and develop practical solutions to accelerate study delivery
• Maintain clinical study approvals, documents, contracts and regulatory submissions
• Mentor colleagues and build strong relationships with sponsors and stakeholders

Required profile

• Bachelor's degree in Life Sciences or a related discipline
• Minimum 7 years of experience in scientific, clinical research, regulatory affairs or site activation
• Demonstrated experience in global or international clinical research programs
• Proven leadership experience with mentoring and influencing others

Required skills

• Strong understanding of the clinical trial lifecycle, drug development and regulatory requirements
• Expertise in GCP, ICH guidelines and applicable regulatory frameworks
• Project, organisational and financial management skills
• Negotiation, communication, presentation and stakeholder management
• Proficiency with clinical systems, databases, CTMS platforms and project tracking tools