This innovative Irish biopharmaceutical client are seeking an experienced Clinical Project Manager to join the clinical team at their Dublin headquarters. This organisation develop products focused on rare and genetic diseases, and have robust pipeline of late stage clinical products. Having recently signed off on an exciting acquisition, they are going from strength to strength. This is a permanent opportunity with a hybrid working model available.
The Clinical Project Manager will manage the day to day activities of the clinical studies. They will be key participants in the overall development of the drug development strategy working directly with both internal and external stakeholders to ensure the best possible service.
Duties and responsibilities of the Clinical Project Manager will include but are not limited to:
- Creation of strategy for qualification and selection of CROs for clinical studies.
- Develop relationships with CROs to ensure that patient enrolment and data collection are completed in accordance with study timelines and objectives; escalates key risks with particular attention to timelines and budget as needed.
- Work with the CRO to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
- Oversee clinical activities and quality by monitoring CROs through reviewing visit reports, protocol deviations, key risks and CAPAs; attend co-monitoring visits as required.
- Develop, review and contribute to study Protocols, eCRF design and completion guidelines, laboratory manuals, Informed Consent Forms, project plans and other study-related documents.
- Perform financial management, including review and approval of site and vendor invoices.
- Track and coordinate trial related materials, including clinical trial supplies and laboratory samples.
- Perform review and QC central clinical files and trial master file.
- Identify potential study issues and recommend and implement solutions or corrective actions as needed.
- Travel to CRO/vendor facilities and/or investigative sites to train and assess study team and CRAs.
You will have skills and experience in the following:
- BSc or MSc with minimum of 5 years pharmaceutical experience in designing/developing clinical studies.
- Clinical trial management experience, including CRO/vendor management, monitoring of budget scope, clinical site monitoring, and knowledge of basic data management / biostatistics processes and pharmacovigilance.
- Experience working in or developing multidisciplinary teams to set up, and conduct clinical studies, preferable in the US and the EU.
- Experience in a specialty pharma, rare disease or orphan indications and marketed products is highly desirable.
To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 632 1885 for a confidential discussion.