Clinical Project Manager ( Medical Devices)
Join to apply for the Clinical Project Manager ( Medical Devices) role at Neuraxpharm
Clinical Project Manager ( Medical Devices)
Join to apply for the Clinical Project Manager ( Medical Devices) role at Neuraxpharm
Get AI-powered advice on this job and more exclusive features.
WE ARE HIRING!
Clinical Project Manager (Medical Devices)
WE ARE HIRING!
Clinical Project Manager (Medical Devices)
Neuraxpharm is looking for people who want to make a difference and improve patients’ lives within the CNS area. We want individuals who will go the extra mile and make great things happen.
Being part of this team does not mean you are just working for a company, but for a cause!
Neuraxpharm is looking for 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 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 the results of clinical trials
* Select and manage CROs, device vendors and other external partners; ensure delivery on time, budget and quality.
* Coordinate multidisciplinary internal teams (clinical, regulatory, quality, engineering) and facilitate decision‑making.
* Prepare and maintain project plans, budgets, risk registers and status reports; escalate issues proactively.
* Interact with EMA and local Competent Authorities for clinical trial applications and early advice.
* Contribute to Module 5 and other sections of combination‑product submission dossiers.
* Preparation and review of documents related to clinical trials: synopsis, clinical study protocols and amendments, informed consent forms, CRFs, clinical study reports, analytical and statistical reports, confidentiality agreements, financing contracts and other relevant documents that apply.
* Interpretation of PK and bioequivalence data.
* Preparation of Module 5 of the drug registration dossier.
* Provide technical support to the Registration Department in its relationship with the Health Authorities during the evaluation of registration files.
We Would Like You To Have
* Minimum 3 years of project management experience in medical device or combination‑product development, with demonstrable leadership of early‑stage clinical studies.
* Hands‑on expertise with PK, bioequivalence, or first‑in‑human trials for injectable or implantable devices.
* Phases 1 experience including Bioequivalence, PK, DDI studies
* Familiar with Competent Authorities interactions (EMA,FDA)
* Clinical Operation Overview experience in therapeutic advanced clinical trials with medical devices will also be valued.
* Strong understanding of ISO 14155, MDR 2017/745 and ICH GCP.
* Proven ability to interpret PK and bioequivalence data.
* Analytical thinking, problem solving, results orientation.
* Excellent communication and stakeholder management.
* Master’s degree in Clinical Trials, Clinical Research.
* English proficiency
About Us
Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders. It has a unique understanding of the CNS market built over 35 years.
Neuraxpharm is constantly innovating, with new products and solutions to address unmet patient needs and is expanding its portfolio through its pipeline and acquisitions.
The company has c. 1,000 employees and develops and commercializes CNS products through a direct presence in more than 20 countries in Europe, two in Latin America, one in the Middle East and globally via partners in more than 50 countries. Neuraxpharm is backed by funds advised by Permira.
Neuraxpharm manufactures many of its pharmaceutical products at Neuraxpharm Pharmaceuticals (formerly Laboratories Lesvi) in Spain.
Be part of the team where you can count on us to deliver:
* Individual Professional development in a leading European pharmaceutical company with an ambitious international growth strategy.
* Attractive remuneration according to the experience and skills provided.
* An inspiring leadership team that drives performance.
* An inclusive culture promoting diversity across the teams that will inspire you every day with a passionate, a dynamic, a result focused and an expert & excellent team!
Interested in knowing more?
Have a look at what Neuraxpharm culture represents and what makes us a great place to work: www.neuraxpharm.com
If you want to join us, this is your opportunity!
WE COUNT ON YOU, YOU COUNT ON US
At Neuraxpharm’s we ensure an inclusive, diverse, safe and respectful work environment for everyone in its organization. As we care for our people as much as we do for our patients, we are committed to guaranteeing a healthy, inclusive and equal opportunity workplace that enables employees to develop their professional potential, while ensuring their individual and collective satisfaction.
We are guided by a Diversity & Inclusion policy to ensure a business culture based on the principles of diversity, equality and inclusion. Our policy complies with European legal regulations and includes the necessary standards, processes and measures to be taken in the event of discrimination or harassment against any employee of the company.
We embrace and promote different cultures, gender identities, seniorities, ages and mindsets within the workplace, to bring different perspectives, styles and experiences to our business.
Seniority level
* Seniority levelMid-Senior level
Employment type
* Employment typeFull-time
Job function
* Job functionProject Management and Information Technology
* IndustriesPharmaceutical Manufacturing
Referrals increase your chances of interviewing at Neuraxpharm by 2x
Get notified about new Clinical Project Manager jobs in Sant Joan Despí, Catalonia, Spain.
Clinical Trial Manager/ Clinical Research AssociateClinical Quality Assurance Manager (6 months fixed-term contract)Clinical Research Associate 2 - Home Based Barcelona / MadridStudy Coordinator (HBP surgery and liver transplantation)In-House Clinical Research Associate I - Portuguese speaker - Europe - Remote
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr