Study Start Up Manager, Biotech

Puesto: Study Start Up Manager, Iqvia Biotech
In this role you lead global study start-up, site activation, and regulatory activities to ensure compliant, timely delivery of clinical trials. You will align cross-functional teams, manage timelines and budgets, and oversee regulatory submissions across regions. You’ll mentor teams, support business development, and optimize processes within CTMS and other systems. This is a high-impact, global position shaping how trials start up and scale to drive patient outcomes.
Lead global and regional site activation and regulatory activities from start-up through maintenance
Develop and execute start-up strategies and regulatory submission approaches to meet timelines
Oversee regulatory submissions, ethics approvals, essential documents, contracts, and site activation deliverables
Provide strategic guidance on regulatory requirements and country-specific risk mitigation
Collaborate cross-functionally with project teams, sponsors, and regional stakeholders
Monitor study progress, quality metrics, timelines, budgets, and resource utilization
Maintain accurate project information within CTMS and other tracking systems
Mentor and coach team members to promote operational excellence
Support business development activities including bid defenses and client presentations
Bachelor's degree in Life Sciences or a related field
Minimum 7 years of experience in clinical research, study start-up, regulatory affairs, or related scientific environment (international experience)
Strong knowledge of clinical trial regulations, GCP, ICH guidelines, and drug development process
Proven experience managing complex, multi-country clinical trial start-up activities
Excellent leadership, stakeholder management, negotiation, communication, and presentation skills
Strong financial, project management, and organizational capabilities
Ability to manage multiple priorities and deliver results via cross-functional teams
Proficiency with CTMS and other clinical research systems and technologies
leadership
Regulatory affairs knowledge