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
Sinead Cullen
Life Science

01 507 9252
[email protected]
Connect with me on
Hot Science Jobs
Manufacturing Technician
Clare
Senior Quality Engineer
Dublin
Sales Specialist (Life Sciences)
Dublin
Bid Response Strategy Manager
Dublin
R&D Manager
Connaught
Senior Product Development Engineer
Galway
Marketing Manager
Galway
R&D Engineer
Clare
Environmental Health & Safety (EHS)
Longford
Senior R&D Engineer
Galway
Quality Assurance Associate
Cork
Senior Process Development Engineer
Dublin
CQV Engineer
Roscommon
Quality Assurance Team Lead
Cork
Validation Engineer
Carlow
Senior Regulatory Affairs Specialist
Athlone
Senior QC Associate (Bioassay)
Dublin
Senior Maintenance Technician
Roscommon
Senior Clinical Data Analyst
Dublin
Manufacturing Technician
Clare
R&D Engineer
Galway
Senior Electronics Engineer
Dublin
Senior QC Associate - Equipment & I
Dublin
Director Engineering & Supply Chain
Galway
Responsible Person (RP)
Republic of Ireland
Senior Microbiologist
Dublin
Quality Manager
Dublin
Senior Maintenance Technician
Kilkenny
Head of Sector (Healthcare)
Dublin
Business Resilience Specialist
Dublin
Senior Quality Systems Engineer
Galway
Equipment Engineer (Syringe filling)
Dublin
Lead MSAT Validation Consultant
Republic of Ireland
Quality Specialist
Tipperary
Senior Design Assurance Engineer
Galway
Quality Engineer
Galway
Principal R&D Engineer
Galway
CTO
Galway
Quality Systems Manager
Dublin
Business Development Manager
Republic of Ireland
Manufacturing Technician
Clare
Quality Specialist
Clare
Director of R&D
Galway
Principal Engineer
Dublin
Senior Quality Engineer
Dublin
EHSS Specialist (Construction & Comm
Athlone
Pharmacovigilance Manager (Remote)
Republic of Ireland
Process Scientist MSAT
Louth
R&D Engineer
Galway
Senior Quality Engineer
Galway
Quality Engineer
Athlone
R&D Manager
Galway
Mechanical Technician
Carlow
Product Development Technician II
Galway
R&D Director
Galway
Key Account Manager - Retail UK National
South East
Microbiology Quality Supervisor
Louth
Staff R&D Engineer
Limerick
Learning Systems Lead
Limerick
Senior Regulatory Affairs Specialist
Clare
Senior Reg Affairs Specialist - Post Mar
Galway
R&D Engineer
Dublin
Black Utilities Engineer
Westmeath
Quality System & Regulatory Affairs
Galway
Quality Assurance Specialist (Hybrid)
Dublin
Senior QC Analyst
Republic of Ireland
Principal Reliability Engineer
Galway
Senior R&D Engineer
Dublin
Product Specialist (Critical Care &
Dublin
Strategic Automation Lead
Waterford
Senior Research & Development Engine
Limerick
Head of Digital & Technology
Dublin
Quality and Regulatory Affairs Manager
Dublin
Product Development Engineer
Galway
Senior Quality Engineer
Leitrim
Design Assurance Engineer
Galway
Senior Quality Assurance Engineer
Galway
R&D Manager
Galway
Project Engineer
Cork
Process Chemist
Limerick
Production Operator
Meath
Principal Engineer
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Senior Quality Assurance Technical Suppo
Dublin
Advanced Technologies Manager
Galway
Microbiology Manager
Dublin
Sr Principal R&D Engineer
Galway
Quality Assurance Specialist/Manager
Dublin
Quality Assurance Senior Specialist
Louth
Tech Transfer Lead
Dublin
Senior Engineering Manager
Galway
Senior R&D Engineer-New Product Deve
Westmeath
R&D Manager
Connaught
R&D Engineer
Galway
Senior Product Development Engineer
Galway
Senior Operations Engineer
Galway
Senior Mechanical Engineer
Dublin
Product Development Manager
Galway
(Senior) Manufacturing Engineers - Globa
Limerick
Quality Control (QC) Technician
Kildare
R&D Director
Galway
Senior Scientist IVD Assay Development
Galway
Quality Manager
Galway
Quality Manager - Medical Devices
Limerick City
Business Development Manager (Hospitals)
Cork
Senior R&D Engineer
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Senior Quality Engineer
Leitrim
Senior Process Engineer - Packaging
Dublin
Calibration Technician
Republic of Ireland
Quality Technician
Dublin
Quality Manager
Galway
Senior R&D Engineer
Galway
Director of R&D
Limerick
Quality Engineer - Supplier
Galway
Principal Device Engineer
Dublin
R&D Manager
Dublin
Senior Audit & Compliance Specialist
Galway
R&D Lifecycle Manager
Connaught
Asbestos Analyst
Down
Lead Mechanical Design Engineer
Limerick
Proposal Manager
Dublin
Product Development Engineer
Dublin
R&D Manager
Galway
Senior Product Development Engineer
Galway
QA Manager
Canada
Senior R&D Manager - Lifecycle Manag
Galway
R&D Engineer
Galway
Injection Moulding Engineer
Athlone
EHSS Specialist
Athlone
R&D Manager
Connaught
Senior R&D Engineer
Galway
R&D Manager
Galway
Senior Equipment Design Engineer
Dublin
Senior Scientific Officer
Dublin
Principal R&D Engineer
Galway
Senior Quality Assurance Engineer
Galway
Senior R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
Senior Process Engineer
Longford
Senior Electronic Engineer - Regulated M
Galway
Asbestos Analyst
Down
Senior Supplier Engagement Manager
Dublin
Principal R&D Engineer
Galway
R&D Engineer
Galway
Senior Operational Readiness Associate
Dublin
Shift Technician (Injection Moulding)
Kildare
Senior Quality Engineer
Dublin
Senior Research and Development Engineer
Galway
R&D Technician II
Galway
Senior Operations Engineer
Galway
Product Development Engineer II
Athlone
Senior Project Engineer
Cavan
CTO
Dublin
Industrial Engineer Capacity Planning
Dublin
Senior Quality Engineer
Galway
Senior Regulatory Specialist
Cork
Senior QC Specialist
Dublin
Senior Clinical Data Analyst
Dublin
Quality Engineer
Wexford
Senior Quality Assurance Associate
Dublin
R&D Engineer
Galway
Engineering Shift Technician
Dublin
QA Engineer
Leitrim
Sustainability Lead (Pharmaceutical)
Dublin
Manufacturing Engineer
Galway
Technical Life Cycle & Engineering M
Galway
R&D Technician II
Galway
Bioinformatician
Dublin
Process Engineer
Leitrim
Principal Process Equipment Engineer
Dublin South
Process Engineer - Sterile Drug Product
Waterford
Senior Process Engineer - DP or DS
Dublin
Director of R&D
Clare
R&D Manager
Athlone
Quality Technician
Galway
Senior R&D Engineer
Galway
Senior Project Manager
Meath
Quality Engineer
Athlone
R&D Director
Galway
Product Specialist (Critical Care &
Dublin
Senior Principal Design and Development
Galway
Documentation Specialist
Louth
Senior Project Engineer
Cork
R&D Engineer
Galway
Senior R&D Engineer
Galway
Project Manager (hybrid)
Dublin
R&D Manager
Athlone
Clinical Trial Protocol Specialist
Galway
Documentation Specialist
Louth
Senior Process Engineer
Dublin
Senior Commissioning & Qualification
Roscommon
Senior Electronics Engineer
Limerick
Inside Sales Support & Sourcing Spec
Dublin
Principal Design and Development Enginee
Galway
Senior Sterile Drug Product MSAT Consult
Republic of Ireland
Senior Manufacturing Engineer
Galway City
LIMS Specialist
Tipperary
R&D Manager
Galway
Regulatory Affairs Manager - Senior
Galway
Manufacturing Specialist (Investigation
Dublin
Principal R&D Engineer
Dublin
Senior Director of Manufacturing and Sup
Galway
Quality Assurance Engineer
Longford
A.I Specialist
Clare
Operations Engineer
Galway
Quality Manager
Galway
R&D Manager
Connaught
Senior Design Engineer
Dublin
Senior QC Microbiology
Dublin
Quality Technician
Galway
Regulatory Affairs Maanger
Galway
Quality Control Analyst (Cell Culture)
Carlow
Senior Equipment Engineer
Dublin
Quality Engineer - Supplier
Galway
Construction Manager - Pharma/Biotech
Dublin
Continuous Improvement Specialist
Dublin
Senior Equipment Design Engineer
Dublin
Senior Clinical Engagement Project Manag
Dublin
Project Manager - R&D
Galway
Senior Regulatory Affairs
Galway
Validation Engineer
Dublin
Product Development Technician II
Galway
Quality Assurance Specialist - Tech Tran
Dublin
R&D Engineer
Galway
Regulatory Affairs Manager- Remote
Republic of Ireland
Project Manager
Kildare
Senior Manufacturing Engineer
Cork
Senior R&D Engineer
Dublin
Quality Assurance Team Lead
Cork
R&D Engineer
Galway
Project Manager
Kildare
Software Design Assurance Engineer
Dublin
Sales/Customer Service Administrator
Clonmel
Senior Manufacting Engineer
Republic of Ireland
Senior R&D Engineer
Dublin
Design Assurance Engineer
Galway
Injection Moulding Engineer
Leitrim
R&D Engineer
Dublin
Engineering Business Manager
Dublin
Principal Design Assurance Engineer
Galway
Senior R&D Engineer
Galway
Clinical Advisor - Wound care (Part-time
Dublin
R&D Engineer
Galway
Senior Design Engineer
Dublin
Senior Electronic Engineer
Dublin
Quality Manager - NPI
Dublin
Sr Electrical 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 Trial Protocol Specialist


Reference:SCA015799 Location: Galway
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Clinical Data Manager, Clinical Project Manager, Clinical Research Associate, Clinical Research Nurse, Clinical Trials Advisor

Clinical Trial Protocol Specialist
Our client an innovative medical device startup are currently recruiting for a Clinical Trial Protocol Specialist to join their team on a permanent basis. As Clinical Trial Protocol Specialist you will lead the design and authorship of investigational protocols across their expanding portfolio. You will work at the intersection of clinical science, regulatory strategy, and study operations.

Responsibilities

  • Lead Protocol Design & Authorship: Oversee Phase I–III oncology trials, including feasibility, pilot, and pivotal studies. Translate scientific hypotheses into operationally- and submission-ready protocols, develop study synopses, and lead protocol amendments.
  • Endpoint & Population Selection: Select appropriate endpoints, patient populations, and clinical instruments, while developing robust scientific justifications for your selections.
  • Documentation Development: Draft and revise core study-specific documentation, including informed consent forms (ICFs) and patient questionnaires.
  • Cross-Functional Collaboration: Partner with biostatistics teams on statistical analysis plans (SAPs), and collaborate with clinical advisors to shape study design, narratives, and scientific rationale.
  • Regulatory Compliance: Ensure all protocols align perfectly with global regulatory guidance and applicable device/drug frameworks. Support regulatory submissions with high-quality protocol documentation.
  • Research & Literature Reviews: Conduct targeted literature reviews to support study design and validate clinical assumptions.
Requirements
Minimum Qualifications:
  • Education: MD, PhD, PharmD, or equivalent advanced degree in life sciences, medicine, or a related field with a demonstrated background in oncology.
  • Experience: 5+ years of experience in clinical trial protocol design and authorship specifically within general oncology.
  • Proven Track Record: Demonstrated ability to independently author protocols for oncology trials.
  • Technical Knowledge: Deep proficiency with oncology-specific endpoints and CTCAE grading frameworks.
  • Regulatory Knowledge: Strong working knowledge of ICH guidelines and FDA regulatory expectations.
  • Communication: Exceptional written and verbal communication and collaboration skills.
Preferred Advantages (Nice-to-Have):
  • Experience with medical device trials (e.g., IDE SR/NSR, De Novo, 510(k) pathways).
  • Experience with clinical trials focused on Quality of Life (QoL) outcomes, physical side effects, or time/financial toxicity.
  • Familiarity with Patient-Reported Outcomes (PROs).
For more information please contact Sinéad Cullen on +353879500821 or [email protected]