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US Clinical Affairs Lead - Medical Devices - US

US Clinical Affairs Manager - Medical Devices - US

US Clinical Affairs Manager

Our Client is a clinical-stage, medical technology company, headquarted in Belgium (Wavre) focused on the development of novel ophthalmic implants for patients with glaucoma. Glaucoma is the second leading cause of adult blindness globally

Reporting to the Senior Director, Clinical Affairs based in the US, The US Clinical Affairs Manager will contribute to all clinical studies in US in accordance with clinical strategy and objectives.

The US Clinical Affairs Manager has the following responsibilities:

Clinical Operations

Assist in managing the overall execution of the Clinical studies in US:

  • Assist in development of specific study-related documents (protocol, IB, ICD, CSR etc.)
  • Assist with development of site training materials
    • Site qualification materials
    • Site initiation presentations
    • Study guidance documents
  • Clinical site activities
    • Site visits to conduct qualification, initiation, clinical data monitoring, and evaluate protocol compliance
    • Assists with monitor training
    • Maintains frequent communication with sites to solve issues arising during the clinical investigation
    • Preparation of site communications, newsletters, meeting minutes etc. to assist with enrolment
  • Coordinates activities related to device distribution and accountability
  • CRO and other external vendors
    • Assists with oversight of work performed by CROs to ensure client requirements are being met
    • Frequent communications regarding tasks, responsibilities, deliverables and milestones
    • Review of monitoring reports and queries
  • Manage EDC development activities with external vendors
    • Ensure eCRFs are aligned with study protocols
    • Ensure EDC forms capture appropriate study related information and are clinically meaningful
  • Track & report trials status (timelines, KPIs, ...)
  • Work with Sr. Director, Clinical Affairs on assigned activities to develop and execute clinical studies

As the successful candidate, you have the following profile:

  • Bachelor’s degree in Life Sciences or other relevant experience (OD or PhD a plus);
  • 3 + years of experience in Ophthalmic Medical Device industry managing IDE studies;
  • Innovative;
  • Ability to manage multiple projects simultaneously;
  • Able to critically evaluate and solve problems;
  • Flexibility (travel from 20% up to 50% of time);
  • Good knowledge of ISO, ANSI and FDA guidelines;
  • Communicator, prioritization, organizational and time management skills;
  • Eager to learn, stress resistant and ready to work independently in a start-up environment (Hands on).

What do we offer?

We offer an US based full-time permanent position along with an attractive remuneration package.

Headed by a solid management team, you will be part of a highly skilled (engineers, scientists) capable and dynamic team of innovative leaders with proven tracks records in the pharmaceutical and medical device industries.

We have an agile start-up company culture focused on values of entrepreneurship, engagement, integrity, passion and excellence.

Excited about the role?
To apply, please send your CV to tvandewoestijne@plusonesearh.be

Publication date

07.04.2021

Contact person

Van De Woestijne

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