Global Study Start-Up Lead

IQVIA; Oeiras; On-site; EUR 85,000 - 120,000; Full time

Job summary

IQVIA Biotech is seeking a Study Start Up Manager to lead strategic planning and execution of site activation across complex, global studies. You will partner with cross-functional teams and clients to ensure timely start-up, compliance, and high-quality delivery in a fast-paced, international environment.

You will provide regulatory guidance, manage project scope and budgets, and mentor colleagues while driving operational excellence and client success across programs.

Qualifications

• Bachelor's degree in Life Sciences or related field required.
• Minimum 7 years in scientific, clinical research, regulatory affairs, or site activation.
• Experience in global/international clinical programs.
• Strong understanding of the clinical trial lifecycle and regulatory requirements.
• Expertise in GCP/ICH guidelines and regulatory frameworks.

Responsibilities

• Lead and oversee global site activation and maintenance activities for assigned studies and programs.
• Develop regulatory and site activation strategies to ensure timely study start-up and ongoing compliance.
• Collaborate with cross-functional study teams, sponsors, and regional stakeholders to hit milestones.
• Provide regulatory guidance to support business development, bid defense, and study execution.
• Manage project scope, timelines, budgets, resources, and quality throughout the lifecycle.
• Identify regulatory risks and develop solutions to accelerate study delivery.
• Oversee maintenance of study approvals, essential documents, contracts, and submissions.
• Mentor colleagues and promote operational excellence across teams.
• Build relationships with sponsors and stakeholders as a trusted SME.

Skills

Leadership

Project management

Regulatory affairs

Stakeholder management

GCP/ICH knowledge

Communication

Negotiation

Education

Bachelor's degree in Life Sciences

Tools

CTMS

Clinical databases

Job description

IQVIA Biotech is seeking a Study Start Up Manager to lead strategic planning and execution of site activation across complex, global studies. You will partner with cross-functional teams and clients to ensure timely start-up, compliance, and high-quality delivery in a fast-paced, international environment.

You will provide regulatory guidance, manage project scope and budgets, and mentor colleagues while driving operational excellence and client success across programs.