Clinical Study Manager

About Aidence

At Aidence we bring together the brightest artificial intelligence scientists, software engineers, medical and regulatory specialists and industry experts to shape tomorrow’s healthcare. Our ambition is to help physicians incorporate AI into clinical practice to deliver outstanding care to their patients. We are currently developing a suite of AI clinical applications for the automatic analysis of medical images. Our first solution focuses on the early detection of lung cancer and heart disease using cutting edge deep learning algorithms.

Aidence is one of the first in the world to commercialise AI-based imaging diagnostics with active installations in multiple European countries and the first steps being made to enter the US market. Aidence is backed by a consortium of local and international top-tier VC’s.

In almost five years Aidence has grown to an international team of around 50 highly motivated, purpose-driven and diverse people with different backgrounds, and personalities. We work closely together to achieve our common goal to transform the oncology pathway using AI. In the first years, our main focus was on building the product. With the new investments we recently received, we are able to further commercialise and deploy our solutions in the healthcare market. This brings a new dynamic within the team, with commercial people working alongside the development team.

Are you a team player, humble and passionate about our purpose? Do you feel excited about being part of a fast-growing start-up that is making a real difference in healthcare?

Then please continue reading because we might be the perfect team to join!

Requirements

Key responsibilities

You will be a part of the medical team and your primary responsibility is to design clinical studies (co-)sponsored and/or supported by Aidence. You will (co-)write study protocols, procedures and reports which need to comply with relevant legislation and (inter)national standards. You will contribute to manage the progress of studies with internal and external stakeholders.

Your key responsibilities are:

  • Translate clinical evidence requirements of the company’s medical device portfolio into comprehensible clinical study designs.
  • Design clinical studies intended for pre-market evidence and post-market surveillance focusing on topics such as (amongst others) clinical efficacy, accuracy, efficiency, impact, cost-effectiveness.
  • Collaborate with, and manage, internal and external stakeholders in order to write executable study protocols and related documents like case report forms and standard operating procedures.
  • Translate study protocols into comprehensive budgets.
  • Prepare and contribute to budget negotiations for the execution of clinical studies with Clinical Research Organizations and Offices.
  • Contribute to managing internal and external stakeholders in order to execute study protocols on time and within budget.
  • (co-)Write documentation for ethics committees or Institutional Review Boards with external stakeholders.
  • Ensure that all clinical studies comply with relevant legislation and international standards.
  • (co)-Write study reports and papers.

What we value

  • Somebody who is passionate about designing high quality studies that are effective, pragmatic and executable.
  • Somebody that gets excited about designing studies that are aimed to close evidence gaps of new technologies and demonstrate their positive impact on patient outcomes and healthcare systems.
  • At least 5 years experience with designing clinical studies, writing study protocols and reports in the area of medical imaging.
  • Experience with designing studies intended to validate the performance of medical devices. Experience with medical imaging and artificial intelligence is preferred
  • Industry experience is preferred.
  • Experience with managing and executing clinical studies.
  • Basic understanding of software tools required to execute imaging studies.
  • Basic knowledge of machine learning and biostatistics.
  • Good understanding of ISO 14155 Clinical investigation of medical devices for human subjects — Good clinical practice.
  • Basic understanding Medical Device Regulations (MEDDEV 2.7/1 / MDR 2017/745, MDCG 2020-1), ISO 13485 (Quality Management) and ISO 14971 / IEC 62366 / FDA Clinical requirements is preferred
  • Excellent scientific writing
  • Work proactively, structured, pragmatic and autonomously but knows when to ask for help
  • Ability to perform effectively in complex and difficult environments
  • Easy communicator with internal & external stakeholders
  • University Master degree such as Medicine, Technical Medicine, Health Sciences, Biomedical Sciences or similar.

The position reports to Chief Medical Officer

Apply here

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