Lead CRA Manager

MEDSIR; Barcelona; Hybrid; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Hybrid work model

Private health insurance

International conference opportunities

Flexible work arrangements

Birthday day off

Job summary

MEDSIR in Barcelona seeks a Lead CRA Manager to steer the Lead CRA team, ensure regulatory and quality standards, and drive strategic monitoring oversight across studies.

You will build strong relationships with internal and external stakeholders, manage resources, and mentor team members to achieve timely delivery and continuous improvement.

Qualifications

• 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 understanding of GCP and ICH guidelines and regulatory requirements.
• Demonstrated ability to lead, develop, and motivate team members.
• Strong leadership and decision-making skills for managing complex timelines and priorities.
• Proven capacity to balance operational detail with strategic oversight.
• Fluent in Spanish and English.

Responsibilities

• Provide strategic direction to the Lead CRA team and translate study priorities into objectives.
• Ensure oversight of IMP forecasting, shipments, supply continuity, and chain-of-custody documentation.
• Establish quality expectations for site files, regulatory docs, and ISFs in line with GCP and procedures.
• Lead stakeholder relationships with internal and external partners incl. international leads, QA, regulatory, CRAs, and sites.
• Oversee monitoring plans, risk-based monitoring, visit reporting and escalation pathways.
• Foster a high-performing, inclusive team with clear objectives and development plans.
• Design training frameworks and onboarding for new team members.
• Identify risks, guide CAPA development, and drive process improvements.
• Monitor workload distribution and collaborate on staffing with management.

Skills

Leadership

Strategic thinking

Stakeholder management

GCP/ICH knowledge

People management

Spanish & English fluency

Project oversight

Education

Bachelor’s degree in Life Sciences/Clinical Research/Pharmacy

Tools

CTMS

EDC

Microsoft Office

Job description

WHY CHOOSE MEDSIR

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. Together, we create the best strategies that are both clinically relevant and scientifically meaningful. We strive to improve our knowledge of this complex disease and the vast array of available treatments in a fast-innovative way.

At MEDSIR, you will have the job of your life while working together towards our shared mission bringing novel treatments to cancer patients worldwide. 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.

ABOUT THE OPPORTUNITY:

The Lead CRA Manager is responsible for resource planning, performance management, capability development, engagement, and the effective resolution of complex operational issues. The role provides strategic direction to the team, translates business and study priorities into team objectives, and ensures consistent delivery across studies.

The Lead CRA Manager reports directly to the Patient Management Director.

HOW YOU WILL CONTRIBUTE:

• Investigational Medicinal Product (IMP) Oversight: Ensure appropriate oversight of IMP forecasting, shipments, supply continuity, and chain-of-custody documentation. Provide direction on complex site or vendor discrepancies and ensure timely escalation and resolution of material risks.
• 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.
• Stakeholder Leadership: Build effective relationships with key internal and external stakeholders, including International Trial Leads, QA, Regulatory, CRAs, sites, and vendors.
• 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. Provide onboarding for new team members.
• Risk & Issue Management: Guide the PML Team in identifying and mitigating risks, guiding CAPA development and follow-up.
• Process Improvement: Drive continuous improvement initiatives across Lead CRA activities. Collect feedback from the team and stakeholders to implement streamlined, standardized practices.
• Operational Oversight: Monitor workload distribution across Lead CRA team, ensuring balance and efficiency. Anticipate resource needs and collaborate with Patient Management Manager for adequate staffing.

WHAT DO WE VALUE FOR THIS OPPORTUNITY?

• 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 understanding of Good Clinical Practices (GCP), ICH guidelines, and relevant regulatory requirements.
• Demonstrated ability to lead, develop, and motivate team members.
• Strong leadership, and decision-making skills, with the ability to manage complex operational issues, competing priorities, and escalations.
• Proven capability to manage multiple priorities simultaneously and maintain stringent trial timelines.
• Proven capacity to balance operational detail with strategic oversight.
• 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.

THE THINGS YOU REALLY WANNA KNOW

At MEDSIR, we believe that employees today want to evolve in collaborative, high-growth environments where they can demonstrate their abilities and thrive both professionally and personally. We are convinced that employees need to find alignment between their inner values and their company’s culture and mission to unlock their full potential. We work to create a culture of empowerment, continuous learning and growth where everyone can bring expertise, own projects and easily measure their impact.

BENEFITS

• Work with world-renowned clinicians and KOL´s on high-level publications and papers.
• 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.
• Positive, dynamic, and passionate work environment.
• Elevate your wellness with Wellhub (formerly GymPass)! One subscription for the best in fitness, mindfulness, therapy, nutrition, and sleep support—all in one place.
• Flexible compensation plan to help you save taxes and increase your net salary (Cobee).
• A free day on your birthday so you can truly celebrate!
• Unforgettable MEDSIR events and regular get togethers.
• Equal employment opportunity, at MEDSIR we proudly pursue a diverse workforce and celebrate our differences.
• A fantastic workplace located near Sagrada Familia.
• We work with MacBook computer (Apple).

If you believe you match our values, you are unique and feel ready to make a change, we look forward to meeting you!

We are committed to fostering a diverse and inclusive workplace, where all individuals are treated with respect and equality, regardless of race, gender, age, religion, disability, or any other characteristic. We believe in providing equal opportunities for all and do not tolerate discrimination in any form.