Medical Research Study Manager
CPL Healthcare
- Cork
- €70,000 per year
- Permanent
- Full-time
- Collaborate with key stakeholders within company , 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 Atlantia 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;
- Monitoring and ensuring study participant safety by reviewing adverse events, safety samples results, clinical assessment and protocol deviations throughout the study;
- Interpreting 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;
- Qualification: Medical degree; registered with the required body in Ireland. Senior SHO or Registrar Level
- 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 organized, capable of working independently with good prioritization and multitasking skills.
- Good understanding of ICH-GCP and clinical research trials.
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