Clinical Project Manager

hace 4 semanas

Barcelona, España Neuroelectrics A tiempo completo

**Who we are**:
Neuroelectrics is a creative, high-tech company offering the best-in-class non-invasive and high-definition electrical brain stimulation technology for personalized neuromodulation. By measuring and modifying brain function, we aim to restore brain health, minimize disabilities and create a better life for patients.
We are looking for new members of our team who already live by our shared values and are inspired by our company's **Vision**. Accelerate the evolution of brain science and technology by delivering advanced solutions to help end patients suffering from brain pathologies; and our** Mission**. Revolutionize the understanding of the brain through new personalized neuromodulation therapies, anywhere and at any time.

**Position Summary**:
Reporting to Clinical Development Director. The Clinical Project Manager is responsible for the overall management of clinical research projects. This involves planning, coordinating, and executing clinical trials and other research studies in compliance with regulatory requirements, protocol specifications, and project timelines.

**What will you do**:

- You will be responsible of the specific clinical investigation sponsored by Neuroelectrics (pilot & pivotal studies) in EU, being a daily point of contact for all members of the project team.
- Planning the clinical project in conjunction with the Clinical Development Director (or delegate) and with study vendors.
- Identify and propose vendors to specific tasks related to clinical investigation according to quality standards.
- Supervise the activities delegated to a CRO/ other vendor by reviewing key study performance/ quality.
- Site monitoring experience ( CRA) is mandatory
- Identify risks; develop and implement the mitigation activities in collaboration with team members and other stakeholders.
- Monitoring the progress of the clinical trial in relation to the project plan and previously defined performance indicators in terms of quality and budget.
- Coordinating clinical development plans & study documents, which are necessary to efficiently reach the defined goal or objectives in agreement with the project team and in compliance with NE’s QMS, ICH/GCPs, medical devices guidelines, EU&US regulations, local requirements, as applicable.
- Participation in the multi-disciplinary project team (including Neuroelectrics´s Product Development, Medical, Quality, Regulatory and Customer Services).
- Reporting the progress to the internal project team.
- Presentation of the CT results, aligned with Clinical Development Director, teams and committees.
- Escalate areas of concern to the Clinical Development Director and the Quality Assurance Department representative as appropriate.
- Clinical Development SOPs updated
- Clinical Evaluation Plan & Report participation

**What do you need**:

- Bachelor's or master’s degree in life science or healthcare; or equivalent combination of education, training, and experience.
- At least 2 years of experience working as a Clinical Project Manager in a medical device development, pilot and pivotal studies from a device company (preferably) or a CRO environment in US and EU.
- Experience in neurology and/or CNS related therapeutic areas is a plus. Technical knowledge of medical devices will be considered.
- Strong knowledge ICH-GCP guidelines, ISO-14155 and FDA requirements for clinical trials/ investigations.
- Knowledge and understanding of medical devices development and the clinical investigation process.
- Knowledge of FDA and EU Regulations and Guidance, as well as global Regulatory Standards and associated ICH Guidelines.
- Proven track record of building relationships with both internal & external stakeholders.
- Proficiency in Spanish desirable

**You will be the perfect fit if you are/have**:

- Passionate about making a difference, gifted with a can-do attitude.
- Reliable, Responsible, and Respectful.
- Good communication and presentation skills.
- Ability to adapt and work effectively within a rapidly changing and growing environment
- Entrepreneurial spirit with the hunger to succeed; act with a founder’s mindset: have urgency, grit, be adaptable to change, and push boundaries.
- Team player, collaborative, innovative, get things done.
- Show initiative in setting and meeting goals within an environment of managed change
- Ability to work under pressure, responsible for multiple vital tasks in parallel
- Commitment to quality.

**If you join us, you will enjoy**:

- Competitive salary in the sector (according to your experience/skills).
- 26 vacation days per year + 24th and 31th of December.
- Fully stocked kitchen (Coffee, organic fruits, snacks, and beverages).
- Flexible Working Hours
- Hybrid work.
- Private Health insurance, including dental coverage.
- Professional development and collaborative environment.
- Unique opportunity to join our company early with excellent market traction and huge potential to grow
- Incredible office in Av

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