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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Medical Study Manager


Reference:SCA013490 Location: Cork
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: BD Manager, Clinical Project Manager, Clinical Research Associate, Clinical Trials Advisor, Doctor (Medical)

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]