Global Study Manager ( Project Manager) - Sponsor-dedicated, in EMEA

Summary

Global Study Manager (Project Manager) – Sponsor‑dedicated, in EMEA. Lead interdisciplinary clinical research studies, ensuring GCP and regulatory compliance, managing timelines, budgets, and financial performance, and serving as the primary liaison between the company and the customer.

Job Responsibilities

• Project Leadership and Delivery: Manage a project as a project manager, overseeing interdisciplinary clinical research studies and ensuring compliance with GCP, relevant SOPs, and regulatory requirements.
• Primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to contractual agreements.
• Lead project team to ensure quality, timelines, and budget management.
• Accountable for the financial performance of each project; coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.
• Ensure studies are conducted in compliance with GCP, relevant SOPs, and regulatory requirements; accountable for all project deliverables.
• Responsible for quality and completeness of TMF for assigned projects.
• Maintain study information on a variety of databases and systems.
• Responsible for study management components of inspection readiness for all aspects of the study conduct; oversee development and implementation of project plans.
• Plan, coordinate, and present at internal and external meetings; prepare project management reports for clients and management.
• Develop contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
• Develop strong relationships with current clients to generate new and/or add‑on business for the future.
• May participate in bid defense meetings where presented as potential project manager.
• May be required to line‑manage other project management team members and clinical monitoring staff.

Qualifications

• Bachelor’s Degree (or equivalent) in life sciences, medicine, pharmacy, nursing, or a combination of education and experience.
• Clinical research organization (CRO) and relevant therapeutic experience preferred; strong knowledge of GCP/ICH guidelines and other applicable regulatory requirements.
• Strong organizational skills.
• Strong ability to manage time and work independently.
• Direct therapeutic area expertise.
• Ability to embrace new technologies.
• Excellent communication, presentation, interpersonal skills, both written and spoken.
• Ability to travel as necessary (approximately 25%).

EEO Statement

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.