Clinical Project Manager

Amsterdam, North Holland, Netherlands | Full-time | Allows remote

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Lightpoint Medical is an innovate medical device company dedicated to improving health outcomes for cancer patients through image-guided surgery. The company’s products address the pressing medical need for better tools to detect cancer during surgery in order to improve clinical outcomes and reduce healthcare costs. At Lightpoint Medical we're building a world-class team to transform the practice of cancer surgery. We hire trailblazing professionals who want to make a meaningful impact. If you think this is you, join us now.

Purpose of the role:

The Clinical Project Manager is responsible for the site selection, set up and management of designated clinical studies to ensure they are delivered in accordance with the business requirements.

Requirements:

  • Degree in a scientific field is preferred
  • Minimum 3 years as a Clinical Project Manager
  • Practical experience of working in house and managing a CRO
  • Good knowledge and experience of clinical study design of European clinical studies in the medical device arena.
  • Experience in the extensive monitoring of clinical studies and resolution of issues at study sites in accordance with all applicable regulations.
  • Experience in overseeing data management function and approving plans for database lock/CSR
  • Experience with UK and European travel with the ability to travel internationally up to 75% of the time.

 

Key responsibilities:

  • To establish good working relationships with international investigators and clinical site staff with the ability to motivate and support.
  • To manage our CRO bought in to run overseas studies
  • To be responsible for all day-to-day decisions and issues relating to the site management of the clinical studies.
  • To perform site assessment visits, initiation visits, monitoring visits and close-down visits in accordance with all the applicable regulations.
  • To perform submissions to Competent Authorities, Research Ethics Committees and hospital departments to expedite the approval process.
  • To manage external resources allocated to a clinical study to ensure quality and deliverables are maintained on target.
  • To maintain compliance with the department procedures and participate in the development and improvement of internal processes.
  • To maintain a high standard of filing accuracy to ensure the study master files are well organized and all essential documentation available.
  • To ensure any safety issues arising during the conduct of clinical studies are reported immediately to the regulatory department.
  • To maintain the highest ethical, clinical and scientific standards ensuring both the safety and wellbeing of study participants and good/rigorous scientific practice.
  • To be flexible in providing assistance to the clinical team with any designated tasks to support the clinical research programme to ensure project timelines are met.

 

Key skills:

  • Practical experience of managing clinical studies including site management and monitoring
  • Practical experience of working with CRO
  • Plan and prioritise own workload to ensure timelines are met, and often work with competing deadlines
  • Independent judgment employed in problem solving site management issues with limited supervision
  • Excellent communication, presentation and facilitation skills including effective negotiation and persuasion skills
  • Must be highly responsible and efficient in dealing with issues in a timely and professional manner
  • Operate in a confidential and professional manner at all times

 

Lightpoint’s close-knit and dedicated staff members are welcoming and friendly and we offer a fast-paced yet flexible working environment. Staff benefits include performance-based tax-advantaged stock options, company pension with matched contributions, income protection and life insurance, annual healthy living allowance, generous holiday policy and flexible working hours.