Clinical Project Manager (Medical Devices)
Join us 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 are proactive and dedicated to excellence.
Being part of this team means working for a cause, not just a company.
We are hiring a Clinical Project Manager (Medical Devices) based in Barcelona (hybrid role).
Your Mission
Lead the development of a medical device combined with a pharmacologically active substance. Plan, design, and oversee clinical activities including PK and bioequivalence studies to generate high-quality data and regulatory dossiers.
Your Major Responsibilities
* Lead projects for drug-device combination development from concept through early clinical phases.
* Plan, contract, and supervise Phase 1 PK/bioequivalence and usability studies complying with ISO 14155, MDR 2017/745, and ICH-GCP.
* Evaluate clinical trial results for consistency and quality.
* Manage CROs, device vendors, and external partners to ensure timely delivery within budget and quality standards.
* Coordinate multidisciplinary teams and facilitate decision-making.
* Prepare project plans, budgets, risk assessments, and status reports; escalate issues proactively.
* Interact with EMA and local authorities for clinical trial applications and advice.
* Contribute to submission dossiers, including Module 5.
* Prepare and review clinical trial documents: protocols, informed consent forms, CRFs, reports, etc.
* Interpret PK and bioequivalence data.
* Support the registration process and liaise with Health Authorities during evaluations.
Qualifications
* At least 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 Phases 1, including bioequivalence, PK, DDI studies.
* Familiarity with EMA and FDA interactions.
* Knowledge of ISO 14155, MDR 2017/745, and ICH GCP.
* Ability to interpret PK and bioequivalence data.
* Strong analytical, problem-solving, and results-oriented skills.
* Excellent communication and stakeholder management skills.
* Master’s degree in Clinical Trials, Clinical Research or related fields.
* Proficiency in English.
About Us
Neuraxpharm is a European specialty pharmaceutical company focused on CNS disorders, with over 35 years of experience. We innovate continuously, expanding our portfolio through pipeline development and acquisitions. With around 1,000 employees, we operate in over 20 European countries, Latin America, the Middle East, and globally through partners. Backed by Permira funds, we manufacture many products in Spain.
What We Offer
* Professional growth in a leading European pharmaceutical company.
* Competitive remuneration based on experience and skills.
* Inspiring leadership and a performance-driven culture.
* An inclusive, diverse environment that fosters passion, innovation, and excellence.
Interested?
Learn more about our culture at www.neuraxpharm.com. Join us and be part of a mission-driven team where your contributions make a difference.
We are committed to a diverse, inclusive, and respectful workplace, ensuring equal opportunities for all employees.
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