Medical Study Manager
Well known Clinical trials company a world class provider of human clinical studies are looking for a Medical Study Manager .
Some of theri extensive clinical areas are healthy ageing, gastrointestinal function and disorder, physical activity and sports performance, nutritional investigations, stress and cognitive health and decline, cardiovascular health, metabolic syndrome, bone and joint health, immune function and microbiome dysbiosis of the gut, skin, vagina and oral cavity.
About the role:
The primary responsibility of the Medical Study Manager is to ensure the safety and wellbeing of the Participants on the clinical trial, and to complete specialized health related assessments and reviewing of safety data in accordance with ICH-GCP principles. They will need excellent communication, presentation skills and the ability to organise both themselves and others.
Key Responsibilities:
- 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;
Requirements:
To be considered for this role, the ideal candidate will have the following:
- Qualification: Medical degree; registered with the required body in Ireland.
- 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.
Competitive salary and benefits included .
For more information contact me contact me at [email protected]