Clinical Project Manager ( Medical Devices)

Neuraxpharm Group; España; Híbrido; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

A leading European pharmaceutical company in Barcelona is seeking a Clinical Project Manager (Medical Devices) to lead the development of drug-device combination products. The ideal candidate will have a Master's degree and at least 3 years of experience in project management within medical devices. This role offers a competitive salary, professional development opportunities, and a hybrid work environment.

Servicios

Professional development

Competitive salary

Inclusive environment

Formación

• Minimum 3 years of project management experience in medical device or combination-product development.
• Hands-on experience with PK, bioequivalence, or first-in-human trials for injectable or implantable devices.
• Proven ability to interpret PK and bioequivalence data.

Responsabilidades

• Lead the early-stage development of a medical device.
• Plan, contract, and supervise Phase 1 PK and bioequivalence studies.
• Prepare and maintain project plans, budgets, risk registers, and status reports.

Conocimientos

Project management

Clinical trials

Stakeholder management

Analytical thinking

Interpreting PK data

Communication skills

Educación

Master’s degree in Clinical Trials, Clinical Research or related field

Descripción del empleo

Clinical Project Manager (Medical Devices)

Join to apply for the Clinical Project Manager (Medical Devices) role at Neuraxpharm.

WE ARE HIRING!

Neuraxpharm is looking for individuals passionate about making a difference and improving patients’ lives within the CNS area. We seek team members who go the extra mile and make great things happen.

Being part of this team means working for a cause, not just a company!

Location: Barcelona (hybrid role)

Your Mission

Lead the early-stage development of a medical device combined with a pharmacologically active substance. Plan, design, and oversee clinical activities including PK and bioequivalence studies to deliver high‑quality clinical data and regulatory dossiers.

Your Major Accountabilities

• Project leadership of drug‑device combination development programs from concept through early clinical phases.
• Plan, contract, and supervise Phase 1 PK / bioequivalence and usability studies in compliance with ISO 14155, MDR 2017 / 745, and ICH‑GCP.
• Evaluate the consistency of clinical trial results.
• Select and manage CROs, device vendors, and external partners; ensure timely, budget, and quality delivery.
• Coordinate multidisciplinary teams (clinical, regulatory, quality, engineering) and facilitate decision-making.
• Prepare and maintain project plans, budgets, risk registers, and status reports; proactively escalate issues.
• Interact with EMA and local Competent Authorities for clinical trial applications and early advice.
• Contribute to Module 5 and other sections of submission dossiers for combination products.
• Prepare and review clinical trial documents: protocols, amendments, informed consent forms, CRFs, reports, analytical and statistical reports, confidentiality agreements, contracts, etc.
• Interpret PK and bioequivalence data.
• Assist in the preparation of Module 5 of the drug registration dossier.
• Provide technical support during registration evaluations with Health Authorities.

Qualifications

• Minimum 3 years of project management experience in medical device or combination-product development, with leadership in early-stage clinical studies.
• Hands-on experience with PK, bioequivalence, or first-in-human trials for injectable or implantable devices.
• Experience in Phase 1 studies including Bioequivalence, PK, DDI studies.
• Familiarity with EMA, FDA interactions.
• Experience in clinical operations for advanced therapeutic trials involving medical devices is a plus.
• Strong knowledge of ISO 14155, MDR 2017 / 745, and ICH GCP.
• Proven ability to interpret PK and bioequivalence data.
• Analytical thinking, problem-solving, results-oriented mindset.
• Excellent communication and stakeholder management skills.
• Master’s degree in Clinical Trials, Clinical Research or related field.
• Proficiency in English.

About Us

Neuraxpharm is a leading European specialty pharmaceutical company focused on CNS disorders, with over 35 years of expertise. It operates in more than 20 European countries, Latin America, the Middle East, and globally through partners, with around 1,000 employees. Backed by Permira funds, it develops and markets CNS products, including manufacturing in Spain.

Why Join Us?

• Professional development in a leading European pharmaceutical company.
• Competitive salary based on experience and skills.
• Inspiring leadership and a performance-driven culture.
• Inclusive environment promoting diversity and teamwork.

Interested?

Learn more about our culture and why Neuraxpharm is a great place to work. Join us and make a difference!

Our Commitment

We foster an inclusive, diverse, safe, and respectful workplace. We are committed to equal opportunities, diversity, and preventing discrimination and harassment, aligning with European regulations.

We celebrate different cultures, genders, ages, and perspectives to enrich our business.

Seniority level: Mid-Senior level

Employment type: Full-time

Job function: Project Management and Information Technology

Industry: Pharmaceutical Manufacturing