CRA Line Manager

About the role

Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications, partnering with small to midsize biotech companies on early-phase trials. As a full-time CRA Line Manager based in Madrid, you will act as the main point of contact for CRAs on non-project-specific matters and manage their performance, training and growth.

Key responsibilities

• Serve as main point of contact for CRAs on non-project-specific needs and manage their performance, training needs and growth opportunities.
• Keep regular contact with CRAs to ensure their knowledge, understanding and compliance with project goals and departmental and corporate objectives.
• Plan and implement resource solutions for new and ongoing projects with the Resourcing team.
• Take part in CRA recruiting, interviewing and hiring, and conduct new employee orientation and onboarding.
• Take part in project-related meetings with Clinical Operations leadership when needed.
• Monitor CRA performance, including oversight of monitoring evaluation visits, and initiate and oversee Performance Improvement Plans when required.
• Help develop department quality standards and programs, and assist in Clinical Operations SOP/WI development and review.
• Build strong relationships with internal and external stakeholders and manage day-to-day operational issues.
• Review and approve timesheets, CRA utilization, non-billable expenses and monthly workload and performance reviews.

Required profile

• BA/BS in a life science field or commensurate experience.
• Demonstrated clinical research experience, including prior site monitoring experience and experience managing CRAs.
• Fluent in English.
• Ability to travel approximately 20% domestically and internationally.

Required skills

• In-depth knowledge of the drug development process, including study initiation, clinical monitoring, drug safety, regulatory affairs, data management and analysis, and clinical study report generation.