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
Senior R&D Engineer
Galway
R&D Senior Program Manager
Galway
R&D Director
Galway
R&D Program Manager
Dublin
Director Engineering & Supply Chain
Galway
Injection Moulding Engineer
Leitrim
Senior Design Assurance Engineer
Galway
Senior Sterile Drug Product MSAT Consult
Republic of Ireland
Injection Moulding Engineer
Athlone
CAPEX API Project Manager
Tipperary
Senior R&D Engineer
Dublin
CTO
Dublin
Construction Manager - Pharma/Biotech
Dublin
QA Manager
Canada
Quality Control (QC) Technician
Kildare
Senior Quality Engineer
Dublin
R&D Technician II
Galway
Senior Quality Systems Engineer
Galway
Head of Sector (Healthcare)
Dublin
Senior Product Development Engineer
Galway
Product Development Engineer II
Athlone
R&D Director
Galway
Quality Assurance Specialist/Manager
Dublin
R&D Engineer
Dublin
Manufacturing Technician
Clare
Senior Regulatory Specialist
Cork
R&D Engineer
Galway
Project Engineer
Clare
Senior Quality Engineer
Leitrim
Senior R&D Engineer-New Product Deve
Westmeath
Microbiology Manager
Dublin
Senior Human Factors Engineer
Galway
Process Engineer - Sterile Drug Product
Waterford
R&D Manager
Athlone
Project Manager - New Product Introducti
Dublin
EHSS Specialist
Athlone
Senior Equipment Design Engineer
Dublin
R&D Engineer
Galway
Injection Molding Engineer
Mayo
Senior QC Microbiology
Dublin
Advanced Technologies Manager
Galway
Senior Project Manager
Meath
Quality Assurance Team Lead
Cork
Senior Reg Affairs Specialist - Post Mar
Galway
Senior Electronics Engineer
Limerick
Injection Moulding Engineer
Athlone
NPI Engineer - Hybrid
Dublin
Principal Design and Development Enginee
Galway
Senior Quality Engineer
Dublin
Senior R&D Engineer II
Galway
R&D Manager
Connaught
Environmental Health & Safety (EHS)
Longford
R&D Engineer
Clare
EHS Specialist II
Limerick
Microbiology Quality Supervisor
Louth
Technology Transfer Specialist, Sterile
Dublin
Process Chemist
Limerick
R&D Manager
Galway
R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
Senior Process Development Engineer
Dublin
R&D Engineer
Galway
LIMS Specialist
Tipperary
R&D Engineer
Galway
R&D Technician II
Galway
Quality Manager
Galway
Quality and Regulatory Affairs Manager
Dublin
Senior Quality Control Associate
Dublin South
Validation & Verification Engineer
Dublin
Quality Assurance Engineer
Longford
Senior Electronic Engineer - Regulated M
Galway
R&D Manager
Dublin
Process Development Engineer
Galway
Sr Electrical Engineer
Galway
R&D Manager
Galway
Senior R&D Engineer
Dublin
Senior Design Assurance Engineer
Galway
Senior Electronic Engineer
Dublin
R&D Manager
Galway
Director of R&D
Limerick
Principal Design Assurance Engineer
Galway
Senior Process Engineer - DP or DS
Dublin
Junior Technology Transfer Lead
Dublin
Principal Reliability Engineer
Galway
Director of Regulatory Affairs
Galway
Quality Assurance Specialist (shift)
Carlow
Senior Regulatory Affairs Manager
Galway
Responsible Person (RP)
Republic of Ireland
(Senior) Manufacturing Engineers - Globa
Limerick
Quality Specialist
Tipperary
R&D Engineer
Galway
Process Scientist MSAT
Louth
Senior QC Specialist
Dublin
Principal R&D Engineer
Galway
Senior Quality Engineer
Leitrim
Senior Clinical Engagement Project Manag
Dublin
Senior Quality Engineer
Galway
R&D Manager
Connaught
Senior R&D Manager - Lifecycle Manag
Galway
Quality Engineer
Galway
Senior Regulatory Specialist
Cork
Senior R&D Engineer
Galway
Senior Manufacturing Engineer
Galway City
Industrial Designer
Galway
Quality Assurance Specialist
Carlow
Senior Supply Chain Project Manager
Dublin
Senior R&D Engineer
Clare
Senior Quality Engineer
Leitrim
Project Manager
Kildare
Quality Specialist
Clare
Manufacturing Technician
Galway
Senior Quality Systems Engineer
Galway
Supply Chain Specialist - New Material I
Meath
Quality Manager
Galway
Quality Systems Manager
Dublin
R&D Lifecycle Manager
Connaught
Senior QC Specialist - Equipment & I
Dublin
Senior Project Engineer
Cork
Process Engineer
Leitrim
Electronic Engineering
Dublin
Senior Specialist MS&T
Dublin
Senior Mechanical Engineer
Dublin
Senior R&D Engineer
Galway
Quality Engineer
Wexford
Senior Manufacting Engineer
Republic of Ireland
Principal R&D Engineer
Galway
Manufacturing Technician
Clare
Sr Principal R&D Engineer
Galway
Quality Assurance Associate
Cork
Lead MSAT Validation Consultant
Republic of Ireland
Business Development Manager
Republic of Ireland
Quality Technician
Galway
Senior Maintenance Technician
Kilkenny
Manufacturing Technician
Clare
Product Development Technician II
Galway
Senior Quality Engineer
Dublin
Director of Regulatory Affairs
Galway
Senior Director of Manufacturing and Sup
Galway
Senior Quality Engineer
Galway
Senior Design Engineer
Dublin
R&D Director
Galway
Senior QC Microbiology
Dublin
Senior R&D Engineer
Galway
Senior Regulatroy Affairs Specialsit
Galway
Senior Scientist IVD Assay Development
Galway
R&D Engineer
Galway
Process Engineer
Galway
Clinical Sales Specialist (Histology)
Dublin
Bioinformatician
Dublin
Inside Sales Support & Sourcing Spec
Dublin
Senior Equipment Design Engineer
Dublin
Mechanical Technician
Carlow
Principal R&D Engineer
Galway
Tech Transfer Lead - Sterile Drug Produc
Dublin
Director of Quality Engineering
Limerick
R&D Engineer
Dublin
Sr Project Manager - Syringe Fill Engine
Dublin
Senior Regulatory Affairs Specialist
Westmeath
Quality System & Regulatory Affairs
Galway
Product Specialist (Critical Care &
Dublin
Senior Quality Engineer
Dublin
Senior Maintenance Technician
Roscommon
Quality Manager
Galway
Senior Regulatory Affairs
Galway
Design Assurance Program Manager
Galway
R&D Manager
Galway
Senior Design Engineer
Dublin
Quality Control Analyst (Cell Culture)
Carlow
R&D Engineer
Galway
CTO
Galway
Project Manager
Kildare
Manufacturing Specialist - Aseptic Proce
Dublin
Clinical Advisor - Wound care (Part-time
Dublin
Lead Mechanical Design Engineer
Limerick
R&D Manager
Galway
Senior Regulatory Affairs Specialist
Clare
Calibration Technician
Republic of Ireland
Operations Engineer
Galway
R&D Manager
Athlone
Principal R&D Engineer
Dublin
Quality Assurance Specialist
Waterford
Senior Process Engineer
Dublin
Senior Maintenance Technician
Kilkenny
Senior Microbiologist
Dublin
QC Microbiology Technician
Kildare
Senior Quality Assurance Technical Suppo
Dublin
Quality Assurance Specialist
Carlow
Senior Associate Quality Control
Dublin
Senior Quality Engineer
Dublin
Technical Life Cycle & Engineering M
Galway
Warehouse Operator
Dublin
Design Assurance Manager
Galway
Senior Quality Engineer
Leitrim
Senior Regulatory Affairs Specialist
Athlone
Senior Manufacturing Engineer
Galway
Pharmacovigilance Manager (Remote)
Republic of Ireland
Senior Supply Chain Manager - Supplier E
Dublin
R&D Engineer
Galway
Senior Operational Readiness Associate
Dublin
Product Development Engineer
Galway
R&D Engineer
Galway
Quality Manager
Galway
Senior Electronic Engineer
Dublin
QA Engineer
Leitrim
Principal Process Equipment Engineer
Dublin South
Principal R&D Engineer
Galway
Senior Equipment Design Engineer
Dublin
Senior QA Associate (shift)
Dublin
Senior R&D Engineer
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
R&D Manager
Connaught
Production Manager
Dublin
Director of R&D
Galway
Senior Operations Engineer
Galway
Senior Maintenance Technician
Kilkenny
Senior Project Engineer
Cavan
Project Engineer
Roscommon
Senior Quality Engineer
Dublin
Manufacturing Specialist (Investigation
Dublin
Design Assurance Engineer
Galway
Senior Clinical Data Analyst
Dublin
Product Specialist (Critical Care &
Dublin
Quality Manager
Galway
Senior Project Manager - Contract Develo
Dublin
Sales/Customer Service Administrator
Clonmel
Senior Quality Engineer
Dublin
R&D Manager
Connaught
Senior Electronic Engineer
Dublin
Senior R&D Engineer
Clare
Quality Engineer
Galway
Director of R&D
Clare
Validation Engineer
Carlow
Principal Quality Engineer
Galway
Documentation Specialist
Louth
Graduate Occupational Hygiene Consultant
Kildare
Senior Engineering Manager
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]