Your new company
The Clinical Operations team is a pivotal function of the Paediatric Centre of Excellence in Dublin and is responsible for the management and execution of Paediatric Clinical Trials, across all therapeutic areas, around the world.
In partnership with Clinical Research, Medical Affairs and other Development Operations functions, Clinical Operations ensures that all clinical trial activities are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high-quality clinical data to support global registration and commercialization of the company’s products.
The Clinical Trial Manager will be a valued member of the Clinical Operations team in Dublin. They will work with the Clinical Program Manager to manage global clinical trials or regional components of global clinical trials and/or the entire process of a local clinical trial, with the ability to identify issues and adapt to changes.

Your new role

• Manages global studies and/or regional components of global Phases II-III outsourced studies managed by a Clinical Program Manager.
• Independently manages all components of a small less complex clinical study.
• Manages cross functional timelines and maintains the study timelines.
• Contributes to the development of the study budget.
• Manages vendors, including CROs.
• Will serve as the primary point of contact for CROs, addressing questions and applying knowledge to resolve problems.
• Assists in determining the activities to support a project’s priorities within a functional area.
• Drafts and coordinates review of relevant documents including protocols, Informed Consents, Case Report Forms, monitoring plans, Investigator Brochures and Clinical Study Reports.
• Must be able to understand, interpret and explain protocol requirements to others.
• Coordinates review of data listings and preparation of interim/final Clinical Study Reports.
• Contributes to development of RFPs and participates in selection of CROs/vendors.
• In collaboration with data management, develops and participates in review of clinical study data and other metrics to ensure data integrity.
• Responsible for filing necessary documents in the electronic trial master file (TMF), and provide oversight for regular cross-functional reviews of the TMF.
• May be asked to train CROs, vendors, investigators, and study coordinators on study requirements.
• May serve as a resource for others within the company for clinical trials management expertise.
• Participate in departmental or interdepartmental strategic initiatives under limited supervision.
• May contribute to development of abstracts, presentations, and manuscripts.
• Supports the professional development and mentoring of Clinical Trial Manager Associates.
• May conduct oversight monitoring visits, as required.
• Travel is required.

What you'll need to succeed

• BSc or BA in a relevant scientific discipline or RN qualification.
• Demonstrated relevant clinical trial experience in the pharmaceutical industry.
• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines and GCP governing the conduct of clinical trials.

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1102958