✨ 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 Start‑Up Expert, reporting to the Start‑Up Manager, supports the Trial Division by managing key Site Network activities during the start‑up phase, with particular emphasis on strategy development, reporting, and operational documentation.

This role delivers administrative and logistical support to the Trial Operations team to ensure the effective execution of clinical trials in accordance with international ICH‑GCP standards, regulatory requirements, and internal SOPs, while supporting the organization's overall strategic goals.

🚀 HOW YOU WILL CONTRIBUTE:

Strategic Study Start‑Up Leadership

• Define and execute global start‑up strategies aligned with clinical development plans and timelines

• Assess protocol feasibility and provide operational input during protocol design

• Lead start‑up planning for Phase I-IV trials, including complex and multinational studies

• Identify start‑up risks early and develop mitigation and contingency plans

• Serve as the start‑up subject‑matter expert for Clinical Operations, PMs, Regulatory, Legal, Finance, and QA

• Lead, coach and mentor junior positions

Feasibilities and pre-feasibilities

· Confidentiality Agreements (CDA) execution

· Create the Pre-Feasibility and Feasibility Questionnaire

· Conduct and review the Feasibility Questionnaire

Site selection

· Identify and select potential sites, and perform the final list

· Track the sites using available systems and tools

· Perform qualification calls/visits to sites

· Ensure sites are fully activated on time and inspection‑ready

Study documentation & Procedures

· Review the Protocol Synopsis

· Develop study material like Monitoring manual, Pharmacy manual, etc)

· Create the study/sites in the Trial Master File

· Coordinate the preparation, distribution, collection and tracking of study documents such as Declaration of Interest, CVs, GCP certificates, etc. for the submissions

· Coordinate, set up and attend project meetings including internal team, CRO /vendor meetings

· Perform quality checks on site essential documents for the Green Light Pack preparation.

· Review pertinent regulations to develop proactive solutions to start-up issues and challenges.

· Overview of the different stakeholders (CRO, vendors) during the set-up phase of the study.

Project Management/Study Plans

· Develop the Risk Management Plan

· Develop the Monitoring Plan incl. forms and templates

· Develop the Communication Plan (if applicable)

Study Set up

· Participate in the studies' kick off meeting

· Assist with identifying and implementing best practices and continuous improvement plans within the company

💪 WHAT DO WE VALUE FOR THIS OPPORTUNITY?

· A university degree in a health-related field.

· Two to four years of experience in Start-up/Set up units.

· Fluent in English and Spanish, both oral and written.

· Ability to work independently with minimal supervision.

· Demonstrated ability to work in a small team setting.

· Strong analytical and problem-solving skills.

· Good computer skills, proficient with MS Office applications and IA applications (desirable).

· Excellent communication skills, organization and planning skills, and attention to detail.

📢 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 (AXA).

🏝 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 in 22@, Barcelona's new hub of innovation.

💻 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.