Study Start Up Manager

We are seeking a seasoned clinical research professional to join IQVIA Biotech as a Study Start Up Manager. You will lead the strategic planning and execution of site activation and maintenance activities across complex, global clinical studies and multi-protocol programs.

Responsibilities:

• Lead and oversee global site activation and maintenance activities for assigned clinical studies and programs.
• Develop and execute regulatory and site activation strategies that ensure timely study start-up and ongoing compliance.
• Partner closely with cross-functional study teams, clients, and country/regional stakeholders to achieve project milestones.
• Provide expert regulatory guidance and intelligence to support business development, bid defense activities, and study execution.
• Manage project scope, timelines, budgets, resources, and quality standards throughout the study lifecycle.
• Identify regulatory risks and challenges, developing innovative and practical solutions to accelerate study delivery.
• Oversee maintenance of clinical study approvals, essential documents, contracts, and regulatory submissions.
• Mentor and coach colleagues, fostering development and promoting operational excellence across teams.
• Build and maintain strong relationships with sponsors and key stakeholders while serving as a trusted subject matter expert.

Requirements:

• Bachelor's Degree in Life Sciences or a related discipline.
• Minimum of 7 years of experience within a scientific, clinical research, regulatory affairs, or site activation environment.
• Demonstrated experience working in global or international clinical research programs.
• Strong understanding of the clinical trial lifecycle, drug development process, and regulatory requirements.
• Expertise in Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and applicable regulatory frameworks.
• Proven leadership experience with the ability to motivate, mentor, and influence others.
• Excellent project management, organizational, and financial management skills.
• Strong negotiation, communication, presentation, and stakeholder management abilities.
• Ability to manage multiple priorities and deliver results within complex, fast-paced environments.
• Proficiency with clinical systems, databases, CTMS platforms, and project tracking tools.

Benefits: No specific benefits mentioned.