Senior Manager Clinical Study Operations

About This Role

This senior manager role involves leading the successful execution of a clinical study portfolio across its entire lifecycle, focusing on quality, risk, and milestones. The position entails managing and developing Local Study Operations Managers and external service providers to ensure high-quality and timely study execution. It suits an experienced leader in clinical research who can foster strong internal and cross-country collaboration.

Responsibilities

• Be responsible for the successful implementation of the assigned study portfolio across the entire study lifecycle, managing portfolio progress, monitoring quality, risks, milestones, and supporting escalations and problem-solving
• Lead and develop Local Study Operations Managers (LSOM) and manage external service providers to ensure high-quality and timely study execution
• Coach, mentor, and promote the professional and career development of LSOMs and build a high-performing team
• Foster close collaboration between the Study Strategy Team, local study teams, and other stakeholders for effective management of the assigned portfolio
• Promote cross-functional collaboration between country teams for successful implementation of the country portfolio and support study placement decisions considering country competencies, capacities, and development potentials
• Proactively manage risks, quality trends, and resources, and continuously optimize operational processes in compliance with regulatory requirements and quality standards
• Manage resource planning and workload distribution (internal employees and external resources/FSP) to optimize study execution and in alignment with global priorities
• Work closely with the Country Head and support cross-functional coordination and escalations

Requirements

• Successfully completed university degree in natural sciences, medicine, or a comparable field, ideally with a doctorate
• At least 7 years of professional experience in clinical research in the pharmaceutical or biotechnology industry or at a CRO is desirable
• Ideally at least 2 years of leadership experience with disciplinary responsibility or proven leadership of complex teams, programs, or projects
• Experience in leading clinical studies within Germany and in the DACH region is an advantage
• Experience in leading cross-functional teams and managing external service providers in clinical research (e.g., CROs, laboratories, or imaging providers) is a plus
• Sound knowledge of local regulatory requirements for global clinical studies is an advantage
• Confident and strong communication skills in German and English (written and spoken; approx. C1 level)
• Strong leadership, communication, and stakeholder management skills, as well as a structured, solution-oriented, and quality-oriented working style