Lead CRA Manager (España)

Lead CRA Manager (España)

23 oct
|
MEDSIR
|
España

23 oct

MEDSIR

España

We are a Barcelona-based fastest-growing company founded by scientific experts . We are dedicated to the design and management of innovative strategic clinical trials in oncology, from study conception to the publication of study results . We welcome top performers that will bring new ideas, diverse perspectives, and provide you the opportunities and freedom to grow and make a real impact ❤ in patients' lives and science… all while having great fun The Lead CRA Manager is responsible for resource planning, performance management, capability development, engagement, and the effective resolution of complex operational issues. The Lead CRA Manager reports directly to the Patient Management Director. Quality, Data & Documentation Oversight: Establish and monitor quality expectations for site files, regulatory documentation, and ISFs, ensuring consistent adherence to GCP, internal procedures, and applicable regulatory requirements. Review trends and define corrective actions when quality standards are not met.
· Monitoring Strategy & Site Support: Provide strategic oversight of monitoring plans, risk-based monitoring approaches, visit reporting standards, and escalation pathways. Ensure the Lead CRA team applies consistent practices and that complex site-management issues are addressed effectively.
· People Leadership & Team Management: Lead and manage the Lead CRA team, setting clear objectives, priorities, and accountability. Conduct regular one-to-ones and performance and development conversations, provide ongoing feedback and mentoring, support career development, and foster an inclusive, collaborative, and high-performing team environment.
· Training & Development: Design training frameworks for PML team ensuring continuous development and harmonized practices across studies. Risk & Issue Management:



Drive continuous improvement initiatives across Lead CRA activities. Monitor workload distribution across Lead CRA team, ensuring balance and efficiency. Anticipate resource needs and collaborate with Patient Management Manager for adequate staffing. Bachelor’s degree in Life Sciences, Clinical Research, Pharmacy, or a related field.
· Significant experience in clinical trial coordination, site management, or regulatory oversight, including responsibility for complex studies.
· Strong organisational, workforce planning, and stakeholder-management skills, with the ability to prioritise across a complex clinical trial.
· Proficiency in Microsoft Office and clinical trial management systems (CTMS, EDC, etc.).
· Fluent in both Spanish and English. We work to create a culture of empowerment, continuous learning and growth where everyone can bring expertise, own projects and easily measure their impact. Fast growth, we are an early-stage company with a multidisciplinary team and many growth opportunities. Work-life balance
- hybrid working model and flexible hours focusing on performance rather than office hours. Unlimited access to GoodHabitz courses and regular workshops (external & internal) to continue your development. Opportunities to participate in scientific conferences & events at national and international level. Private health Insurance. Work-from-abroad policy depending on position and local legislation. A young & international team with a company culture focused on development. ☕ One subscription for the best in fitness, mindfulness, therapy, nutrition, and sleep support—all in one place. "Versátil compensation plan" to help you save taxes and increase your net salary (Cobee). Unforgettable MEDSIR events and regular get togethers. A fantastic workplace located near Sagrada Familia. We work with MacBook computer (Apple).

📌 Lead CRA Manager (España)
🏢 MEDSIR
📍 España

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