Clinical Project Manager

Allergy and Immunology > Allergy and Immunology
Other (specify in description)
Not Mentioned
France
11 Aug 2022

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.

R&D is the engine of our business here at Hologic, our R&D teams sit at the cutting edge of technology, our innovations are designed to achieve exceptional clinical results making it possible to detect, diagnose and treat illnesses and other health conditions earlier and with more certainty.

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

 #LI-KP1


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