Dublin (Hybrid model)
Clinical Operations Manager (COM)
1. Full working knowledge of and competence with Microsoft Office.
2. Proven organisational skills.
3. Working knowledge of clinical trial process an advantage.
4. Science or nursing qualification
To carry out administrative duties on assigned studies in line with ICH-GCP, applicable regulatory requirements and guidelines, SOPs, study protocols and study-specific procedures.
• To provide additional administrative support to Clinical Operations Department and office where required.
• Preparation of Trial Master Files and Investigator Site and Pharmacy Files, including printing, filing, and tracking of clinical trial documents.
• Serving as administrator of the Trial Master File with direction from Project Management, including the preparation, maintenance, and archiving of the TMF.
• Coordinate the preparation, collection, tracking and filing of essential documents including centralised documents (Investigator/ investigational site staff CVs, Investigator Agreements, GCP certificates, laboratory accreditation, etc.)
• Preparation of site-specific study documents, including patient related documents under the guidance of the Clinical study team.
• Collating and sending clinical trial documents to hospital sites and Sponsor. Ordering and tracking of clinical trial supplies and investigational product.
• Assist in the logistics for bio-sample shipments.
• Processing study subject registrations for Cancer Trials Ireland studies.
• Responsible for main reception phone, stationary supply and other office tasks as part of the office administration team.
• Coordinate queries and direct issues to appropriate clinical research personnel.
• Assist Data Management with collation and tracking of Case Report Forms (CRFs), including generation of specific Data Management reports.
• Organise meetings, prepare agendas and minutes.