Clinical Research Manager

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Dublin, Dublin, Ireland

Dublin, Dublin, Ireland

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Job Title: Clinical Research Manager Department: Office of Research and Innovation Reporting to: Associate Director of Research Location: 118 St. Stephen's Green, Dublin Contract/Duration: Special Purpose contract (maternity leave) - Full Time Closing Date: 9:00am on Thursday 28th of May About Our Research RCSI recognises that excellence in research is critical to the quality of its educational activities, its credibility, and, overall, to its mission to enhance human health. RCSI's research strategy aims to build upon its strength in translational biomedical and clinical research to deliver transformational, high impact changes in health care. Targeting both Irish national and EU funding, along with increased collaboration with industry, is a major part of the RCSI research strategy. Forging increased collaboration between RCSI PIs and industry is of critical importance to achieving success in this area. RCSI is also committed to provide its researchers with the supports and developmental opportunities to enable them to continuously grow and support their overall career development. Summary of Post Full time clinical research manager supporting the activities of the RCSI Sponsorship Office. This position will involve the provision of support, coordination and management for RCSI Sponsor Office's administrative activities. Candidate Requirements: Degree level qualification in a clinical or life sciences related subject. Significant project management experience, preferably in a clinical research setting. Strong organisational skills Experience in managing and co-ordinate diverse activities. Excellent IT skills including Microsoft Office (particularly Word, Excel, Teams and PowerPoint). Good decision making, critical thinking and problem resolution based skills. Ability to build strong working relationships and demonstrates good leadership skills. Effective oral and written communication skills. Attention to detail and the ability to work effectively in an environment characterized by tight timelines and changing priorities. Self-motivated, able to work independently, as well as in multi-disciplinary teams, and with the intellectual flexibility to continually develop and learn new skills to compliment the position. Specifically, the duties of the post are: Study Planning Stage: Manage Sponsorship Office enquiries. Coordinate and monitor the completion of clinical study assessments and registration activities. Assist with the registration of studies on Liaise with Clinical Research Contract manager, manager execution, filing and tracking of Clinical Trial Agreements. Study Implementation Stage: Administer the greenlight for non-regulated interventional studies. Support green light activities for regulated studies. Provision of support with monitoring scheduling and follow up letter communication, as needed. General: Maintain the tracker of the studies reviewed and sponsored (where applicable) by RCSI Sponsorship Office. Act as RCSI point of contact for the Beaumont RCSI joint approval process, monitor and update tracker and provide documentation on behalf of Sponsorship Office Coordinate Sponsorship Office meetings (set agenda, circulate actions and follow up) Manage Sponsorship payment requests, including liaison with Investigators and Finance Dept. Manage Sponsorship Office timekeeping system and reports. Contribute to and coordinate the preparation of the annual presentation for the RCSI Executive Research Management Team. Organize inter-departmental meetings and meetings with external parties. and liaison with RCSI insurance broker. Liaise with Investigators and RCSI insurance broker for clinical trial's related insurance queries , policy updates and renewal. Prepare documentation and liaise with RCSI insurance broker for the annual clinical trial insurance renewal. Manage the Sponsorship Office email account and queries. Triage the pharmacovigilance email inbox and regulatory system daily for notifications. Maintain Sponsorship Office filing system (as required) and contribute to the development/ amendment of SOPs. Manage the Honorary Research Appointment process. Update sponsorship section of clinical research handbook (as needed). Professional development opportunities and requirements Undertake further education as appropriate to keep updated with changes within the field of Clinical Research (as required) Take responsibility for own professional development and skills updating including maintaining a record of training, continuing education and continuing professional development. Attend and participate in: In service and staff education. Sponsor Management meetings. Appropriate outside conferences and/or other professional development activities. We are all too aware that imposter syndrome and the confidence gap can sometimes stop fantastic candidates putting themselves forward, so please do submit an application - we'd love to hear from you. Application Process Please apply online through the RCSI careers portal on the closing date with your CV and cover letter. Click here to read our Recruitment and Selection Policy for Researcher. Informal Enquiries: Informal enquiries are invited in the first instance through Dr. Paola della Porta, Associate Director of Research - Email: All applications for this post must be made through the career's webpage Please note that we do not accept CVs directly. Garda vetting and occupational health review may be required for this role, depending on the nature of the duties and responsibilities. Further information will be provided during the recruitment process.

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Dublin, Dublin, Ireland

Sprachkenntnisse

English

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