Global Study Lead

Contract with unlimited duration

Responsibilities:

• Provides subject matter expertise on specific Clinical Operations activities either directly related to or in support of executing studies and/or enabling projects
• Accountable for activities that contribute to the outcome of one or more studies and/or Clinical Operations enabling projects
• Identifies, contributes to, and participates in continuous improvement and change management activities to solve complex problems and bring new perspectives to existing solutions in support of diagnostics solutions and/or enabling projects
• Independently and with minimal guidance develops plans, creates and manages budgets, and ensures the consistency of studies and/or projects that support studies
• Collaborates across Clinical Operations and other functions to develop and implement best practices across Clinical Operations
• Understands, applies good knowledge of applicable standards and regulations (ICH-GCP, IVDD/IVDR, MDR, SaMD, FDA, NMPA regulations etc) in the review of studies and/or other associated projects
• Drive patient and customer-centricity (mindset, behaviors and actions) by always putting the needs of patients and the customers first
• Partner across diverse regions, cultures, and time zones to create an environment of belonging, inclusion and diversity
• Demonstrate flexibility and adaptability to perform in a fast-paced, matrixed environment where fluid, cross-team collaboration is crucial
• Leverage excellent verbal and written communication skills
• Works closely with Medical Affairs in cross-functional collaboration (e.g. with Regulatory Affairs, R&D, Clinical Operations teams) to support global strategies and planning of timeline and costs
• Drives process improvements, harmonization and evolution of processes and templates
• Oversees planning and operational aspects of Investigator Initiated Studies and Research Collaborations
• Accountable for study-level budget of assigned studies

Must Haves:

• Minimum of bachelors degree in Life Science and/or relevant expertise in the Healthcare Industry or a related field
• Minimum 1 year of experience in study management or clinical project management
• Conceptual and practical knowledge of Clinical Operations or related areas
• Knowledge of best practices and the role of Clinical Operations in product development
• Solves complex problems; takes a new perspective on existing solutions; exercises judgment based on the analysis of multiple sources of information