I'm looking for...
close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome
IE
Internet Explorer
firefox
Mozilla Firefox
opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Contact Info
James Cassidy
Life Science

+353 1 5079250
[email protected]
Connect with me on
Project Manager
Limerick
Senior R&D Engineer
Limerick City
EHS Manager
Dublin
Project Engineer
Limerick
R&D Manager
Limerick
QC Scientist
Limerick
Lab Manager
Meath
C&Q Engineer
Dublin
Validation Lead
Limerick
Planner
Limerick
Project Engineer
Limerick
Analytical Chemist
Waterford
Technical Writer
Limerick
Analytical Chemist
Waterford
eClinical Project Coordinator
Republic of Ireland
Clinical Research Associate (CRA)
Republic of Ireland
Senior Lab Analyst
Waterford
Quality Engineer
Limerick
Senior Planner
Limerick
R&D Manager
Galway
CTO
Dublin
Head of R&D
Galway
Process Engineer
Dublin North
eClinical Project Manager
Republic of Ireland
Analytical Chemist
Waterford
Process Engineer
Limerick
R&D Engineer
Limerick City
Project Engineer
Limerick
QA Manager
Dublin
NPI Manager
Dublin
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to [email protected]
Details

Clinical Trial Project Manager


Reference:JCAO1212 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed

Our client a high potential medical device start up is looking to hire a Clinical Trial Project Manager reporting to a VP of Clinical and Regulatory the Clinical Trial Project Manager will support the study team in the development and execution of clinical trials globally to deliver trials. Company is well funded and have a management team with a proven track record in start up. Role can be done remotely


Role/Responsibilities

  • Oversee, design, plan and develop global clinical trials. Use project management skills, processes and tools to develop and execute global clinical trials on time and to budget. Work to reduce risk and maintain accurate study schedules and deliverables. Regularly communicate the study status and timelines and escalate unresolved issues appropriately to the Senior Management team
  • Oversee and resolve operational aspects of clinical trials in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations. Combine scientific, regional, and operational knowledge as well as process expertise to impact clinical trial design, feasibility and implementation.
  • Leverage scientific and regulatory knowledge to prepare clinical and regulatory documents (protocols, case report forms, etc).
  • Develop or provide operational input to the development of study documents, including study protocols and Investigator’s Brochure
  • Drive and coordinate cross-functional study team throughout site activation, enrolment, follow up and closure, empowering them to meet the clinical trial deliverables, including issue management, contingency planning and issue resolution.
  • Training site personnel on study documentation.
  • Support trial/regional enrolment strategy and execution.
  • Oversee the timely supply of all materials to sites.
  • Manage relationships and serve as a single point of contact for trial communication. Represents the company from a clinical research perspective to clinical sites.
  • Oversee results of clinical investigations in preparation for new device application.
  • responsibility for management of essential documents and Trial Master File where applicable, ensuring inspection-readiness.
  • Identify and assist in developing continuous improvement activities.
  • Ensure interactions with colleagues/stakeholders fully reflects the company values:

Education and Experience
  • Degree in science or health-related field
  • Minimum of four (4) years of related experience in clinical research
  • Cardiovascular experience preferred
  • Detailed knowledge of global/regional regulations (e.g. 21 CFR 812, ISO 14155) & Good Clinical Practice (GCP)
  • Strong working knowledge of the clinical research processes and tools
  • Experience of preparing clinical documentation
  • Vendor management experience preferred
  • Excellent communication, organisational and time management skills
For further information please contact James Cassidy [email protected] or call in confidence 0860204322