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
Job Tools
Contact Info
Colin Clare
Life Science

+353870608656
[email protected]
Connect with me on
Hot Science Jobs
Senior Process Engineer
Dublin
Senior Design Engineer
Dublin
Analytical Scientist
Meath
Manufacturing Technician
Clare
Injection Moulding Engineer
Leitrim
R&D Engineer
Galway
Senior Associate Quality Control (Shift)
Dublin
Senior Equipment Design Engineer
Dublin
Quality Manager
Dublin
Product Development Engineer II
Athlone
Maintenance & Reliability Technician
Limerick
Senior Product Development Engineer
Galway
Quality Engineer
Galway
Warehouse Operator
Meath
R&D Engineer
Galway
Territory Manager (Woundcare)
Cork
Design Assurance Engineer
Galway
R&D Engineer
Galway
MS&T Bioprocess Engineer
Meath
Sr R&D Manager
Galway
Injection Moulding Engineer
Athlone
Operational Excellence Specialist
Cork
Operations Engineer
Galway
Senior Research & Development Engine
Limerick
Program Manager
Dublin
Project Manager - R&D
Galway
Technical Transfer Specialist - Remote
Republic of Ireland
Quality Engineer
Wexford
R&D Manager
Galway
Senior Electronics Engineer
Limerick
Documentation Specialist
Louth
National Sales Manager
Dublin
Principal R&D Engineer
Galway
Pharmacovigilance Manager (Remote)
Republic of Ireland
Biomedical Engineer
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Project Manager
Galway
Product Development Technician II
Galway
R&D Manager
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Senior Recruitment Consultant
Republic of Ireland
Team Leader - Lab Services
Dublin
R&D Engineer
Galway
Microbiology Manager
Dublin
Regulatory Affairs Maanger
Galway
CTO
Galway
Senior R&D Manager
Athlone
Project Manager
Kildare
Engineering Shift Technician
Dublin
Mechanical Technician
Carlow
Senior Microbiologist
Dublin
Manufacturing Engineer
Galway
Principal R&D Engineer
Galway
Senior Equipment Design Engineer
Dublin
Technical Life Cycle & Engineering M
Galway
Senior R&D Engineer - Sustaining
Galway
Product Development Engineer
Dublin
Technology Transfer Specialist
Meath
Quality Manager - NPI
Dublin
R&D Engineer
Galway
R&D Engineer
Galway
Senior Engineering Manager
Limerick
R&D Manager
Connaught
Project Engineer
Cork
Associate Director - Manufacturing &
Limerick
Senior Regulatory Affairs
Galway
Advanced Technologies Manager
Galway
R&D Engineer
Galway
Account Manager (Chemicals) - Dublin
Dublin
Electronic Engineer
Dublin
Quality Specialist
Clare
Regulatory Affairs Specialist
Cork
Manufacturing Engineer
Cork
Project Engineer
Limerick
Maintenance CMMS Engineer
Tipperary
Software Design Assurance Engineer
Dublin
Senior Manufacting Engineer
Republic of Ireland
Senior Associate Quality Control
Dublin
Site Microbiologist
Republic of Ireland
Change Control SME
Cork
Principal Process Equipment Engineer
Dublin South
Responsible Person (RP)
Republic of Ireland
Product Development Manager
Galway
Principal R&D Engineer
Dublin
Project Manager - R&D
Galway
Senior Regulatroy Affairs Specialsit
Galway
Senior Principal Design and Development
Galway
E&I Turnover Engineer
Carlow
Senior Quality Engineer
Galway
Documentation Specialist
Louth
Design Assurance Program Manager
Galway
Advanced Technologies R&D Manager
Clare
R&D Engineer
Galway
R&D Engineer
Galway
Senior Design Engineer
Dublin
Senior Equipment Design Engineer
Dublin
R&D Senior Program Manager
Galway
Process Chemist
Limerick
Project Manager
Louth
Senior Project Engineer
Cavan
Senior R&D Manager - Lifecycle Manag
Galway
Clinical Research Associate
Cork
Senior R&D Engineer-New Product Deve
Westmeath
R&D Manager
Connaught
Purchasing & Planning Manager
Wexford
Strategic Automation Lead
Waterford
R&D Engineer
Dublin
QA Manager
Canada
Senior R&D Engineer
Galway
R&D Director
Galway
R&D Manager
Galway
Cleaning Validation Specialist
Cork
Quality Technician
Dublin
Project Manager - R&D
Galway
Principal Software Engineer
Athlone
Senior R&D Engineer
Dublin
R&D Manager
Athlone
Operations Supervisor - Evening Shift (M
Sligo
Advanced Technologies R&D Manager
Clare
Purchasing & Planning Manager
Wexford
Senior Regulatory Affairs Specialist
Athlone
Senior Quality Control Associate
Dublin South
Health & Safety Specialist
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Principal R&D Engineer
Dublin
Senior Recruitment Consultant
Dublin
Design Assurance Engineer
Clare
Senior R&D Engineer
Galway
Senior R&D Engineer
Dublin
R&D Engineer
Clare
Electronic Engineer
Dublin
Principal Reliability Engineer
Galway
Maintenance Reliability Engineer
Cork
Quality Engineer
Galway
Senior R&D Engineer - Sustaining
Galway
Product Development Engineer II
Athlone
Senior R&D Engineer
Galway
R&D Manager
Galway
R&D Technician
Galway
Project Manager
Kildare
Product Development Engineer
Galway
CTO
Dublin
Documentation Specialist - Upstream Oper
Dublin
Cleaning Validation Specialist
Cork
Senior Mechanical Engineer
Dublin
Senior Design Assurance Engineer
Galway
Quality Engineer
Athlone
Quality Engineer
Galway
R&D Director
Galway
Injection Molding Engineer
North Leinster
Senior Regulatory Affairs Specialist
Athlone
Senior R&D Engineer
Galway
Product Development Engineer
Dublin
Senior R&D Engineer
Galway
Senior R&D Engineer
Galway
Quality Engineer
Galway
R&D Manager
Galway
Quality Control Analyst (shift)
Carlow
Senior Quality Engineer
Dublin
Senior R&D Engineer
Galway
R&D Engineer
Dublin
Maintenance Manufacturing Technician
Kilkenny
Injection Molding Engineer
North Leinster
Senior Electronic Engineer
Dublin
Process Engineer
Carlow
QA Engineer
Leitrim
Senior Recruitment Consultant
Republic of Ireland
Quality Manager
Galway
Calibration Technician
Republic of Ireland
Senior R&D Engineer
Galway
Senior R&D Engineer - Sustaining
Galway
Product Development Manager
Galway
R&D Engineer
Galway
Value Stream Team Leader / Production Su
Wexford
Electronic Engineer
Dublin
Lead Maintenance Reliability Engineer
Westmeath
Electronic Engineering
Dublin
Senior R&D Engineer
Galway
Injection Moulding Engineer
Athlone
Senior QC Associate
Dublin
R&D Manager
Galway
Design Assurance Program Manager
Galway
R&D Project Manager
Galway
MS&T Scientist - AKTA systems
Meath
Warehouse Operator
Meath
Project Manager Design Assurance
Galway
Senior Validation Engineer
Louth
Validation Engineer
Athlone
Project Engineer
Clare
Manufacturing Technician
Clare
Senior Product Development Engineer
Galway
Engineering Support Specialist
Louth
Senior Regulatory Affairs Specialist
Clare
Manufacturing Project Engineer
Sligo
R&D Manager
Connaught
Project Manager (hybrid)
Dublin
Project Engineer - Senior
Cavan
Senior R&D Engineer
Dublin
Quality Specialist
Tipperary
Senior R&D Engineer
Galway
R&D Manager
Connaught
Facilities Engineer
Carlow
Quality Assurance Senior Specialist
Louth
R&D Director
Galway
Product Development Technician II
Galway
Senior Electronics Engineer
Dublin
Design Quality Engineer
Galway
Regulatory Affairs Associate
Cork
R&D Director
Galway
Principal Instrumentation & Calibrat
Limerick
R&D Manager
Athlone
Quality Manager
Galway
Quality Manager - Medical Devices
Limerick City
Continuous Improvement Coach
Limerick
Process Engineer
Galway
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 Research Manager


Reference:CCL (AHPD-441807) Location: Cork
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: BD Manager, Clinical Project Manager

Job Title:Clinical Research Manager
Location:Bishopstown, Cork
Benefits:Excellent salary, bonus, healthcare and pension, hybrid /remote

Company:
My client are a medical‐device company specialising in ENT (Ear, Nose & Throat) innovations. Their goal is to simplify surgical procedures in ENT, improving patient safety, reducing costs, and shifting some procedures out of the operating room environment. The company was spun out of Munster Technological University (earlier Cork Institute of Technology) in 2015, based on research from the Medical Engineering Design & Innovation Centre (MEDIC).

The Role:
The role of Clinical Research Manager will involve designing, planning, implementing, and managing the overall conduct, or particular elements, of clinical research projects. The goal of the CRM is to ensure compliance with the protocol and overall clinical objectives as well as applicable SOPS and regulations. This position requires an enthusiastic self-starter with a willingness to be a “hands-on” contributor. Excellent organisational skills, ability to balance immediate vs. long term priorities and strong multi-tasking skills are a necessity. An ability to work in a flexible and small entrepreneurial environment is essential.

Responsibilities:

  • Taking a leadership role in the activities of interdisciplinary team members in the planning, executing and closing of both pre-market and post-market clinical studies
  • Developing and approving study-specific documents, tools, presentations and processes
  • Prepare ethics submissions and study specific documents such as protocols, patient information leaflets, informed consent forms and case report forms,
  • Maintain and/or delegating responsibility to maintain Trial Master Files and Investigator Site Files for multiple studies
  • Preparing and presenting at Investigator meetings
  • Taking a leadership role in the site qualification, study initiation and study closure process
  • Maintain and/or delegating responsibility to the management of medical device tracking and accountability
  • Creating and maintain study databases, including data entry, routinely reviewing data/CRFs to ensure data integrity, accuracy and protocol compliance
  • Tracking and reporting progress of studies to applicable internal stakeholders including: patient screening, enrolment, data collection, adverse event documentation and reporting
  • Developing study reports and providing clinical reports for regulatory submissions
  • Perform or delegate monitoring and site visits including preparation of site visit, data query, adverse event and study deviation reports
  • Acting as a company liaison to work with clinical sites, Contract Research Organizations (CROs), Site Management Organisations (SMOs) and other vendors/consultants
  • Maintaining familiarity with all applicable regulatory requirements and relevant clinical literature
  • Maintaining compliance with ISO 13485, ISO 14155, ICH GCP, EU MDR, US 21CFR820, Declaration of Helsinki, Data Protection Act and any other clinical study/trial regulations.
  • Carry out other clinical related duties as required.
  • Carrying out activities related to QMS documentation control as required.
Education:
  • Bachelor’s degree in Science or related disciplines with a minimum of 5-8 years of experience in the medical device industry, specifically in clinical studies.
  • Experience in pre-market and post-market clinical studies of medical devices essential
  • Clinical certifications strongly desired
  • Thorough understanding and knowledge of ISO 13485, ISO 14155, ICH GCP, US 21CFR820 and EU MDR.
  • Proven track record with the ability to successfully manage projects to deadlines
  • Strong ability to manage critical projects as part of an interdisciplinary team
  • Excellent problem solving and communication skills
  • Must be self-motivated, highly organised and detail oriented
  • Excellent oral and written communication skills
  • Must be able to work as part of a cross functional team
  • Thrives to work in a fast-paced / entrepreneurial environment

Does this sound like your next career move? To apply and For more info forward your application to the link provided or contact me on 087 0608656 [email protected]