Senior Clinical Project Manager

hace 3 días

Barcelona, España Neuroelectrics A tiempo completo

We are looking for a Senior Clinical Project Manager who will have the responsibility is to oversee the clinical investigations (pilot & pivotal) sponsored by Neuroelectrics.

Start date: ASAP

The Senior Clinical Project Manager is the main responsible of the specific clinical investigation sponsored by Neuroelectrics (pilot & pivotal studies) in US, being a daily point of contact for all members of the project team.

Required education:

- Bachelor's or master’s degree in life science or healthcare; or equivalent combination of education, training, and experience.

**Responsibilities**:

- 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

**Requirements**:

- 6-8 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. Technical knowledge of medical devices will be considered.
- Strong knowledge of ICH-GCP guidelines, ISO-14155 and FDA requirements for clinical trials/investigations.
- Excellent written and oral communication skills.
- Strong organizational and skills, with emphasis on team player attitude and team-building skills.
- Ability to manage multiple tasks in a fast-paced environment with changing priorities.
- Ability to work independently, with mínimal supervision.
- Strong negotiation skills, flexibility & ability to provide a solution-based approach to emerging challenges.

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