PlusOne

Clinical Study Manager - Medical Devices - Liège

Company

Our client is a medical device company specialized in improving clinical outcome of patients with impaired cardiac function, active in interventional cardiology. The company has developed a high potential proprietary technology that consists of hardware, software and catheter(s).

The technology is in advanced clinical stage, with various potential therapeutic applications.

Role

You are looking for a professional challenge that allows you to work in a fast-moving and clinical stage company in order to work on Medical Devices Projects?

After a strong experience as CRA, you want to endorse new responsibilities as Clinical Study Manager? Thanks to that operational experience of Clinical activities you want to bring your expertise to a more helicopter level?

Plus One can offer you this great challenge:

Your key responsibilities:

• You support clinical project(s) and program(s) in Europe, in collaboration with internal and external partners.

• You ensure that assigned clinical study project(s) are managed in respect of established timelines and quality and regulatory standards.

• You develop and manage study-related documents and necessary structures for efficient running of clinical studies.

• You deal with product-related site request and solve issues.

• You ensure that all necessary ethics committee and hospital approvals are obtained.

• You provide operational input (and scientific if appropriate) into Protocol synopsis, Study protocol and all other study related documents.

• You author Informed Consent Form, Study Operations Manual, monitoring plan, and other study essential documents.

• You are the point of contact for CRAs and coordinate support needs for the sites.

• You will co-monitor or monitor clinical data at the sites as needed.

• You work closely with the CRAs and the research teams at the sites to ensure that all protocol required procedures and visits occur according to protocol specified guidelines and timely entry of the data in the electronic database.

• You train and support CRAs/CROs on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility.

• You manage clinical trial adverse event and device deficiency workflows.

• You report results and work evolution on a regular basis to your line manager.

Profile

  • Bachelor’s or master’s degree in Biomedical Sciences, or equivalent through experience.
  • At least 5 years’ experience in clinical research (including experience as CRA) on international level for medical devices, ideally cardiac implantable devices.
  • Qualified knowledge of Medical Device Regulations on conduct of clinical investigations (ISO14155, GCP, EU MDD, EU MDR)
  • You are able to understand and interpret medical device regulations and standards and apply them in a practical and consistent manner.
  • You have strong knowledge and understanding of clinical research context and related documents.
  • You are autonomous and have a hands-on and pragmatic mind-set.
  • You are able to work and collaborate effectively with internal and external actors to achieve company objectives.
  • You are fluent in English. A good command of French and other languages is an asset.
  • Proficiency with common business software, such as MS Office applications.

Offer

  • A challenging and diversified position within a high-potential innovative medical device company.
  • To work in a human size, dynamic, respectful and professional environment.
  • International exposure, with learning and development opportunities.
  • An attractive compensation package in line with the position responsibilities and your experience.

Publication date

06.12.2019

Contact person

Gaëlle Minet

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