Global Clinical Operations Leader

NAMSA; Madrid; Vor Ort; EUR 80.000 - 110.000; Vollzeit

Zusammenfassung

NAMSA in Madrid is seeking a seasoned Clinical Operations Leader to oversee global and regional clinical, biostatistics and data management activities. You will manage Clinical Associates, allocate workloads, and ensure regulatory compliance while aligning local requirements with global strategies.

The role involves coordinating client expectations, budget oversight, and staff development. Fluency in English and local language is required, with travel up to 20% as needed.

Qualifikationen

• Bachelor’s degree or equivalent experience in a related field with a minimum of 5 years of relevant experience.
• Fluency in English and local language, if different, required.
• Knowledge of Good Clinical Practices and other regulations which apply to clinical trials at various stages of development (feasibility, pivotal, post-market)
• Familiarity with Medical Device product development process.
• Familiarity with the role of study management, data management and biostatistics in the clinical trial process.

Aufgaben

• Assists in planning, and coordinating both global and regional clinical, biostatistics and data management operational activities of the Clinical Department as applicable.
• Manages select Clinical Associates within the Clinical Department.
• Allocates workload for all clinical, biostatistics and data management projects; May take on all the duties and responsibilities of one or more of the functions of the direct reports and/or lead projects, as needed
• Confirms appropriate regulations and procedures are applied and followed for relevant operational services. Works with regional Director and global leaders to balance alignment with local requirements and global approach.
• Works with staff to ensure client expectations are met including schedule, cost and quality of services.
• Intervenes and problem-solves with challenging clients as necessary.
• Provides opportunities and coaching to promote education and further direct reports’ understanding of the clinical development process including client business strategy, local regulatory and marketing requirements, and challenging financial, technical, client service and timeline issues.
• In conjunction with the global team, proposes and implements systems to support internal improvement and NAMSA’s long-term growth.
• Maintains qualified staff by recruiting, selecting, orienting, and training Associates, and developing personal growth opportunities via training plans, quality oversight/assurance and/or career path planning.
• In support of the clinical department financial goals, may assist with budget forecasting requirements/capacity; preparing annual budgets; scheduling and overseeing expenditures, analyzing variances; and initiating corrective actions.
• Participates in meetings with prospective clients.
• May present on clinical topics at regional and local conferences, seminars and NAMSA events, as needed, and supports team member involvement in these activities.
• Provides scope of project and relevant information to support the creation of proposals. Identifies opportunities to bring in new projects/clients.
• Offers opportunities to clients for expansion of services to be provided by NAMSA.

Kenntnisse

Project management

Client communication

Leadership

Regulatory knowledge

Budgeting/Forecasting

Ausbildung

Bachelor’s degree

Tools

Microsoft Office

Jobbeschreibung

NAMSA in Madrid is seeking a seasoned Clinical Operations Leader to oversee global and regional clinical, biostatistics and data management activities. You will manage Clinical Associates, allocate workloads, and ensure regulatory compliance while aligning local requirements with global strategies.

The role involves coordinating client expectations, budget oversight, and staff development. Fluency in English and local language is required, with travel up to 20% as needed.