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
Sinead Cullen
Life Science

01 507 9252
[email protected]
Connect with me on
Senior Quality Engineer-Remote
Republic of Ireland
Project Engineer
Republic of Ireland
Recruitment Consultant
Republic of Ireland
Graduate Laboratory Technician
Republic of Ireland
Head of R&D
Galway
Quality Specialist
Tipperary
R&D Manager
Galway
Senior Manufacting Engineer
Republic of Ireland
Project Engineer
Tipperary
C&Q Lead
Tipperary
Senior Recruitment Consultant
Republic of Ireland
QC Analyst
Meath
R&D Manager
Galway
Chemical Engineer
Tipperary
Project Engineer
Limerick
R&D Director
Galway
Trainer
Dublin
Senior Recruitment Consultant
Republic of Ireland
Responsible Person (RP)
Republic of Ireland
CQV Lead
Tipperary
R&D Manager
Galway
Medical Device Director
Republic of Ireland
R&D Director
Galway
Qualified Person
Limerick
R&D Manager
Galway
R&D Director
Galway
Process Engineer
Limerick
R&D Engineer
Dublin
Project Manager
Limerick
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

Medical Study Manager


Reference:SCA013490 Location: Cork
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Medical Study Manager
Our client, a world class provider of human clinical studies are currently recruiting for a Medical Study Manager to join their team on a permanent basis. As Medical Study Manager you will ensure the safety and wellbeing of the Participants on the clinical trial. The Medical Study Manager be responsible for completing specialised health related assessments and reviewing safety data in accordance with ICH-GCP principles. The successful candidate will be a qualified medical doctor, registered with the IMC and have experience in clinical trials/clinical research.


Responsibilities:

  • Collaborate with key stakeholders, as well as the Sponsor to develop study protocols that outline the objectives, study endpoints, participant eligibility criteria and safety related information
  • Assist in the safety aspects of study start-up by reviewing key documents and eCRF design templates
  • Develop Safety Monitoring Plans for all studies and train team members on important study specific safety related information
  • Develop and maintain other safety documentation as required
  • Provide medical expertise and guidance to members of the clinical project team to ensure compliance with the protocol and SOPs when conducting health related assessments
  • Monitor safety by reviewing adverse events, safety sample results, clinical assessments and protocol deviations
  • Organise a safety monitoring review schedule for each study and complete safety monitoring reviews as per the schedule, raising queries to the team and arranging feedback sessions as well as trainings where required
  • Review medical history and concomitant medications for eligibility
  • Monitor and ensure study participant safety by reviewing adverse events, safety samples results, clinical assessment and protocol deviations throughout the study
  • Interpret study-appropriate laboratory tests, x-rays, electrocardiograms and diagnostic procedures specified in the protocol
  • Conduct clinical assessments such as medical/physical exams and other clinical procedures as required by different trials
  • Refer participants for laboratory tests, x-rays, DXAs, electrocardiograms and diagnostic procedures specified in the study protocol
  • Work directly with the clinical project teams to educate them on clinical research care process
  • Be the main medical point of contact for the Sponsor and any third parties during all phases of the study lifecycle
  • Partake in site initiation visits, population review meetings and sponsor update meetings as required
  • Responsible for the final safety review with Sponsor during study close out
  • Support the commercial team during project scoping, providing input to proposals where required
  • Assure department staff complete orientation, maintain clinical competence, complete continuing education and evaluated promptly
  • Assist the Science team with Clinical Study Reports
  • Attend and present at relevant conferences when required and represent the organisation
  • Support multiple projects at different stages of the clinical research process in accordance with Good Clinical Practice (ICH/GCP) guidelines
Requirements:
  • Medical degree and registered with the IMC
  • Good understanding of ICH-GCP and clinical research/clinical trials
  • Strong clinical competency, good bedside manner and experience in dealing with different population ages
  • Good communication skills and interpersonal skills to engage well with colleagues and the general public
  • Highly organised, capable of working independently with good prioritization and multitasking skills

For more information contact Sinéad Cullen on +353879500821 or [email protected]