Start-up Expert (clinical trials)

✨ 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 position undertakes a variety of the daily activities of the Site Network, focusing on reports and operational documents during the Start-up phase and follow-up trial phase is applicable.

Start-up Expert provides administrative and logistics support within the Trial Operations team in the successful execution of clinical trials complying with international Good Clinical Practice (GCP) guidelines/regulations and Standard Operating Procedures (SOPs).

This position is based in our Trial Division, and reports to Start-Up Manager.

🚀 ACCOUNTABILITIES:

Feasibilities and pre-feasibilities

• Create and follow-up the Pre-Feasibility and Feasibility process.
• Conduct the Feasibility Questionnaire. 
• Conduct the Feasibility by sending the Protocol or Synopsis.
• Collect signed CDA and pre-feasibility.

Site selection

• Identify potential sites.
• Perform the final list of sites. 
• Send an email to the selected and non-selected sites. 
• Enter selected and non-selected sites in our System (PARTRIAL).
• Qualification site visits (if applicable) (Included Site Feasibilities, CDAs with PIs). 

Study documentation & Procedures

• Develop Patients materials & Investigator fees - Study Budget.
• Protocol Synopsis (check regulations of each country), ICF, Patient materials (patient diary, instructions for the patient) – translation to each language.
• Development of Study Materials (patient diary, instructions for the patient).
• Monitoring manual & study manuals (Lab manual, eCRF, Imaging manual, etc).
• Create the Trial Master File.
• Follow up and conduct the Randomization or Enrollment procedure. 
• Coordinate the preparation, collection, distribution and tracking of study documents such as confidential disclosure agreements (CDA), Financial Disclosures, contracts, newsletters, etc.
• Coordinate, provide set up, and attend project meetings including internal team, CRO /vendor meetings, support presentations, etc.
• Perform quality checks on submission documents and site essential documents.
• Prepare and approve informed consent forms.
• Review pertinent regulations to develop proactive solutions to start-up issues and challenges.

Project Management/Study Plans 

• Develop Risk Management Plan. 
• Develop Monitoring Plan incl. Forms and Templates. 
• Develop Communication Plan (if applicable). 
• Central laboratory services management plan. 
• Data management plan. 
• Data validation plan/Query Plan. 
• Communication and Scientific charter.
• Experience with study submission in CTIS.
• Medical Monitoring Plan. 
• Coordinate the development Safety Management Plan – by Pharmacovigilance vendor. 

Study Set up

• 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 English, both oral and written. 
• Portuguese command would be desirable but not mandatory. 
• 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 (Word y Excel) applications.
• Excellent communication skills, organization and planning skills and attention to detail.
• Must be able to communicate effectively in English language.

📢 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 with Cigna for you and your loved ones.

🧘Unlimited sessions with a clinical therapist to unfold/display your best emotional wellbeing. Leverage your mental health with our partnership with ifeel!

🏝 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.

💪 Gympass!

💸 "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 with beautiful views @Torre Glòries, 27th floor in Barcelona.

💻 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!