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Contact Info
James Cassidy
Life Science

+353 1 5079250
james.cassidy@lifescience.ie
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Details

Clinical Operations Lead


Reference:JCACEB-037504 Location: Republic of Ireland
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Clinical Operations Lead

Our client an innovative medical device company developing a cardiology device are currently seeking a Clinical Operations Lead to manage the execution of the Company’s clinical development and to manage, plan and execute the Company’s clinical programme (first in human and feasibility studies).

Role/Responsibilities

Facilitating and developing the design of the clinical programmes incuding
interventional (first in human and feasibility studies), non-interventional and
investigator led clinical investigations.
Planning and execution of the Company’s clinical programme to required
international medical device standards
Support clinical site selection and qualification process overseeing the assessment
of sites i.e. sites are adequately staffed and trained to perform the required tasks
(protocol adherence, data reporting requirements, IRB reporting, regulatory
requirements).
Be involved in monitoing and close of clinical sites.
Maintaining professional and credible image with key physicians, clinical
investigators and consultants, liaising with all these relevant stakeholders to ensure
efficient and timely clinical study execution
Conducting briefing and technical meetings for internal and external
representatives
Forecasts and manage study related finances within agreed budgets and
communicate on project status to wider team
Manage the Contract Research Organisation and independent contractors relevant
to the execution of the clinical programme
Manage and track study related activities in-house and at site and identify mitigate
study related issues in a timely and efficient manner
Support the running of internal and external meetings as needed by the project.
Other duties to include support the development of the technical documents,
organising key publications and performing literature searches
Engage with the QMS to ensure delivery of the overall quality strategy &
support the achievement of the business quality objectives

Skills/Experience
Medical or scientific education with qualification to master's degree level or
higher.
6+ years' experience from similar positions in the medical device industry
Experience in cardiology medical device trials.
Desirable
Project management qualification
Good working knowledge of FDA and ICH/GCP and European Medical Device
regulations and willingness to continuously expand medical, scientific, market,
and industry knowledge
Motivated, self-starter and an organized individual with strong scientific
background with the ability to work in teams.
Good interpersonal skills and the ability to build strong relationships with key
stakeholders.
Technically excellent with PowerPoint, excel, word and reference management
tools and all other packages to support the clinical fuction.
Excellent written and verbal communication skills



James Cassidy | Tel: +353 (0) 1 5079250