Clinical Project Manager Med Device
il y a 1 mois
Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.
We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging full-service, functional service provider and consulting - allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial, and human knowledge to improve the patient journey.
For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.
**Context**:
The mission consists in the management of international clinical studies in pre-CE marking or post-CE marking in Europe and in the USA:
- Responsible for managing Clinical studies activities as assigned by the CAM with an entrepreneurial
approach that requires the ability to multi task on a wide spectrum of activities.
- Plan, coordinate and manage the overall execution of the assigned clinical studies to be compliant with quality, budget and timelines, including making or recommending operational strategies and/or decisions (with input from CAM and CMO) in support of achieving clinical studies objectives.
- Coordinate multidisciplinary project team members related to project management activities requiring interaction with internal groups (e.g. Regulatory Affairs, Logistics, Quality Assurance, Marketing and Business Development) and external groups (e.g. external services providers).
- Create, contribute to, and implement study specific clinical documents and monitoring tools: clinical
protocol, Informed consent, Trial Monitoring Plan, CRF pages, Safety Records form, and study
tracking
- Prepare clinical submission and obtain Competent Authorities and Ethics Committee approvals for
assigned trials
- Establish the process for the site agreements, contracts, and financial/site payment tracking during study conduct and implement procedures to streamline efforts across multiple departments.study conduct and implement procedures to streamline efforts across multiple departments.
- Provide operational oversight and guidance to support prioritization of activities, review and monitor the work performed, metric compliance, and development of contingency plans, among others.
- Ensure quality and adherence to Standard Operating Procedures (SOPs) and compliance with local guidelines and ICH GCPs.
- Conduct various types of assessment visits to ensure Clinical Operations on-site performance.
- Develop and oversee training plans to address performance deficiencies.
- Organize and lead clinical trial meetings at regular intervals.
- Responsible for program budget planning and accountable for external spend related to program budget planning and accountable for external spend related to program execution
- Oversight of Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned program, including escalation of issues.
- Participate in the design, writing and review of Clinical SOPs and associated documents
**Skills and Experience**:
- Excellent verbal, written and presentation skills - in English
- Good analytical, negotiation and synthesis skills
- Leadership skills
- In-depth knowledge of clinical research and medical devices: ISO 14155, European DM regulations 2017/745, FDA CFR
- Scientific or quality background.
- At least 3 years of experience in a project manager position
**Summary**:
- Type of job:
Full-time
- Location:
Boulogne-Billancourt, Ile-de-France, France
- Capability:
Clinical Research
**Contact**:
- Talent Acquisition Manager
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