WE ARE HIRING!
Clinical Project Manager (Medical Devices)
Neuraxpharm is looking for motivated individuals who want to make a difference and improve patients’ lives within the CNS area. We seek professionals willing to go the extra mile to achieve great results.
Joining our 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 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 responsibilities :
* Lead project development of drug-device combination programs from concept through early clinical phases.
* Plan, contract, and supervise Phase 1 PK / bioequivalence and usability studies in compliance with ISO14155, MDR 2017 / 745, and ICH-GCP.
* Evaluate clinical trial results for consistency and accuracy.
* Select and manage CROs, device vendors, and external partners, ensuring timely delivery within budget and quality standards.
* Coordinate multidisciplinary teams (clinical, regulatory, quality, engineering) and support decision-making processes.
* Prepare and maintain project plans, budgets, risk registers, and status reports; proactively escalate issues.
* Communicate with EMA and local authorities for clinical trial applications and early advice.
* Contribute to Module 5 and other sections of combination-product submission dossiers.
* Prepare and review documents related to clinical trials, including protocols, amendments, consent forms, CRFs, reports, and contracts.
* Interpret PK and bioequivalence data effectively.
* Assist in preparing Module 5 of the drug registration dossier.
* Provide technical support to the Registration Department during evaluation processes with health authorities.
We would like you to have :
* Minimum 3 years of project management experience in medical device or combination-product development, with leadership of early-stage clinical studies.
* Hands-on expertise with PK, bioequivalence, or first-in-human trials for injectable or implantable devices.
* Experience with Phases 1 including Bioequivalence, PK, and DDI studies.
* Familiarity with interactions with authorities like EMA and FDA.
* Experience in clinical operations for advanced therapeutic clinical trials involving medical devices will be valued.
* Strong understanding of ISO14155, MDR 2017 / 745, and ICH GCP standards.
* Proven ability to analyze and interpret PK and bioequivalence data.
* Analytical thinking, problem-solving skills, and results orientation.
* Excellent communication and stakeholder management skills.
* Master’s degree in Clinical Trials or Clinical Research.
* Proficiency in English.
ABOUT US
Neuraxpharm is a leading European specialty pharmaceutical company focused on CNS disorders, with over 35 years of experience. We innovate continuously, expanding our portfolio through pipelines and acquisitions.
With approximately 1,000 employees, we operate in more than 20 European countries, Latin America, the Middle East, and globally through partners in over 50 countries. Neuraxpharm is backed by Permira funds.
We manufacture many of our products at Neuraxpharm Pharmaceuticals in Spain.
What we offer :
* Professional development in a leading European pharmaceutical company with an ambitious international growth strategy.
* Attractive remuneration based on experience and skills.
* Inspirational leadership fostering high performance.
* An inclusive culture that promotes diversity, driven by a passionate, dynamic, results-focused, and expert team.
Interested in knowing more?
Discover what Neuraxpharm's culture is about and why we are a great place to work.
If you want to join us, this is your opportunity!
WE COUNT ON YOU, YOU COUNT ON US
We ensure an inclusive, diverse, safe, and respectful work environment. We are committed to a healthy, inclusive, and equal opportunity workplace that fosters professional growth and individual satisfaction.
Our Diversity & Inclusion policy aligns with European regulations, ensuring standards against discrimination and harassment. We celebrate different cultures, genders, ages, and mindsets to bring diverse perspectives to our business.
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