Clinical Trial ManagerIreland - DublinClinical Development & Clinical OperationsRegular
The Clinical Operations team in Gilead Dublin 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 Gilead’s products.
The Clinical Trial Manager will be a valued member of the Clinical Operations team in Dublin. He/She 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.
- 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.
Knowledge, Experience & Skills
- BSc or BA in a relevant scientific discipline or RN qualification.
- At least five years relevant clinical trial experience in the pharmaceutical industry.
- Demonstrates an ability to manage studies or programs of higher complexity from both a process and strategic perspective.
- Ability to work independently with minimal oversight, identify issues and adapt to changes.
- Demonstrates an ability to interact with contacts cross-functionally at senior levels within the Company.
- Able to examine functional issues from an organisational perspective.
- Must be able to prioritise multiple tasks, plan proactively and accomplish goals using well defined instructions and procedures.
- Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.
- Must have a general understanding of functional issues and routine project goals from an organisational perspective.
- Must have a general, functional expertise to support SOP development and implementation.
- Excellent teamwork, communication, decision-making and organizational skills are required.
- Knowledge of FDA and/or EMEA Regulations, ICH Guidelines and GCP governing the conduct of clinical trials.
- Excellent verbal, written, interpersonal and presentation skills are required.
- Working knowledge and experience with Word, PowerPoint and Excel.