Trainee Clinical Trial Protocol Writer

MEDSIR; Barcelona; Híbrido; EUR 18.000 - 24.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid working model

Study compensation for transport and食

MacBook provided (Apple)

Courses & workshops access

Conferences participation

Birthday day off

Diversity & inclusion

Descripción de la vacante

MEDSIR, a Barcelona-based biotechnology company, offers an opportunity for a trainee to contribute to the design and revision of clinical trial proposals and protocols in oncology. You will assist in scientific and medical writing, collaborate with experts, and support registry setup to advance trials worldwide.

As a trainee, you will develop skills in medical writing, project planning, and regulatory compliance while benefiting from a hybrid work model and opportunities to participate in

Formación

• University degree in health or life science-related field.
• Basic understanding of clinical research principles; GCP training valued.
• Solid writing and organizational skills with attention to detail.

Responsabilidades

• Assist in generating and reviewing scientific documents for trial design.
• Identify scientific/clinical assumptions impacting project plan and budget.
• Ensure deliverables comply with ICH, GxPs and guidelines.
• Set up new clinical trials in registries (clinicaltrials.gov, EUCT).
• Monitor deadlines and ensure timely delivery of projects.
• Stay updated with medical literature and trends.
• Support defense of proposals with external clients and collaborators.
• Participate in department procedures and administrative tasks.
• Protect information and report security concerns as required.
• Adhere to Ethics & Compliance and attend trainings.

Conocimientos

English proficiency

Writing skills

Team collaboration

Analytical thinking

Educación

Health or life sciences degree

Herramientas

MS Office

Clinical trial registries

Descripción del empleo

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

IMPORTANT REQUIREMENT

• Signed agreement with your academic centre MANDATORY

The main objective of this role is to support the development and revision of the design of clinical trial proposals and protocols. As a Trainee, you will assist in various projects under development until they are ready for execution in hospitals worldwide, contributing to both the scientific and clinical development and the medical writing.

HOW YOU WILL CONTRIBUTE

As trainee you will be involved in and learn about:

• Assist in generating and/or reviewing scientific documents required as part of the design of new MEDSIR clinical trials or updates on existing projects. Documents might include but are not limited to synopsis of new clinical trials, protocols, and other trial-specific documents that require specialized scientific and medical knowledge. This may include direct involvement in the preparation of those documents or supervision of outsourced activities.
• Help identify and provide the key scientific and clinical assumptions that impact the project plan and budget.
• Ensure that all deliverables are in accordance with applicable regulations, standards, and guidelines, such as ICH, GxPs, Scientific and Company guidelines.
• Assist in setting up new clinical trials in public registry databases (clinicaltrials.gov, EUCT, or equivalent databases).
• Monitor deadlines and ensure projects are delivered within agreed timelines.
• Stay current with medical literature and advancements by keeping abreast of current literature, emerging science, technological developments, and medical trends.
• Support in the defense of proposals with external clients (such as pharmaceutical companies) and collaborators (such as renowned oncologists).
• Participate in the definition and improvement of department and company procedures.
• Participate in the administrative requirements of the department.
• Protect information from unauthorized use or access and notify the Information Security Officer and the Management System Officer in the event of such unauthorized access or use.
• Abide by the internal regulations, raise concerns and breaches related to compliance obligations, and collaborate with Ethics & Compliance as required.
• Participate in scheduled company trainings.

WHAT DO WE VALUE FOR THIS OPPORTUNITY?

• University degree in health or life science-related field, such as Biology, Biochemistry, Biomedicine, Genetics, Biotechnology, Medicine, Pharmacy or a related discipline.
• Basic understanding of clinical research principles. Specific training in clinical trials, Good Clinical Practice (GCP), or related areas will be highly evaluated.
• Solid writing and organizational skills with meticulous attention to detail.
• Proficiency in computer skills, including search databases, and MS Office package or equivalent.
• Motivation and ability to keep scientific knowledge updated in areas required by the company projects that include but are not limited to Oncology, Molecular Biology, Digital Innovation in Health Sciences. Academic background or demonstrated interest in oncology, including knowledge of different tumor types, will be highly valued.
• Ability to interpret clinical data and other complex information and communicate in a clear and concise manner.
• Ability to communicate effectively in English and preferably in additional languages.
• Strong interpersonal, communication, facilitation, and presentation skills. Candidate must be able to work collaboratively with colleagues across all functions and at all levels.
• Strong analytical and problem-solving skills.
• Ability to work well independently or as part of a team in a deadline-driven environment.
• Flexible attitude in response to time demands and unexpected events.

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

Study compensation support for basic transport and food expenses

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.

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.

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.

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.