Clinical Project Manager
Clinical Project Manager
Role location: Aix-en-Provence, France
Department: R&D, Breast & Skeletal Health Division
Here at Hologic the opportunities to grow, progress and unleash your talents are immense. Join us in a role that will affect the lives of millions. Unleash your true potential and drive your success in a company that is as ambitious and future focused as you are.
We have an exciting opportunity for a talented and results-oriented Clinical Project Manager to join our team In France. In this role you will oversee and execute clinical trials across multiple phases of medical devices development – ensuring on-time, on-budget, and high-quality execution, and conduct.
You will have knowledge of standards and regulations of clinical evaluation, excellent communication and negotiation skills and natural curiosity about new technology. This is a great new role where you will have the opportunity to experience the full lifecycle of a project, join a fantastic team and award winning workplace environment.
KEY RESPONSIBILITIES
- Drive the planning and execution of clinical studies from study start to closure. Deliver high-quality studies, on-time and on-budget, in compliance with all applicable domestic and international regulations and standards (GCP and ICH).
- Lead the creation, management, and execution of advanced clinical programs in support of product development and evidence generation activities.
- Partner with Clinical Development to ensure the appropriate design and reporting of clinical studies.
- Prepare and/or critically review project/study protocols, informed consent, site instructions, study manuals, IRB submissions
- Select and manage CROs and other consultants/vendors, including contract/budget negotiation, and overseeing CRO activities beginning from CRO award through trial close‐out
- Participate in the preparation of regulatory filings and interactions with regulatory bodies, as needed.
- Collaborate with functional departments such a Clinical Development, R&D, Program Management, Regulatory Affairs, Legal, Marketing, Service and Operations across global regions
- Oversee clinical activities related to EU MDR, including management of clinical documents and deliverables
KNOWLEDGE, SKILLS & EXPERIENCE
- Degree in a relevant scientific or healthcare related field
- Strong track record in managing complex clinical studies
- Experience in clinical trial management with a sponsor or CRO
- Knowledge of ISO 13485, European Medical Device Regulation 2017/745, GCP, ICH GCP E6; ISO 14155:2020
- Knowledge of the US Quality Management System Regulation 21 CFR part 820 – is highly desirable
- Excellent communication, presentation and organizational skills
- Demonstrated ability to think strategically, set and manage priorities, manage multiple projects and allocate and reallocate resources and effort as required
- Ability to travel worldwide and to work in an international environment; fluent written and spoken English and French
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