Clinical Program Manager
Join a dynamic team in Dublin as a Clinical Program Manager on a permanent basis. This key role will be responsible for the planning, development, and management of Clinical Operations activities.
Key Responsibilities
* Manage clinical project and site operations, including trial timelines, resources, vendors, and budgets.
* Lead the development of clinical trial protocols, participating in overall clinical planning, drafting protocols, collaborating on statistical analysis plans, and coordinating protocol review and approval processes with regulatory agencies.
* Select potential investigators and clinical sites nationally and internationally, conduct pre-study site visits, collect and review data, and prepare evaluative reports.
* IDentify contract research organizations and centralized services such as clinical laboratories, assess their qualifications and experience, and participate in final selection and contract negotiation.
* Oversee research technical and/or trial administrative staff, including hiring, training, goal-setting, and workload distribution.
* Develop strategic plans and lead or contribute to assigned global initiatives and process improvements.
Requirements
* Bachelor's degree required, Master's preferred.
* A minimum of 5 years of clinical operations experience, with increasing levels of responsibility, in the Pharmaceutical or Biotechnology industry.
* Three or more years of clinical program management experience at a trial sponsor, either in a large pharmaceutical company or in a biotech start-up environment is an advantage.
* Therapeutic experience in infectious diseases, diabetes, or oncology.
* Strong knowledge of clinical research concepts, practices, and EMA/FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and data management methods.
* Frequent travel may be required as per job demands.
* Proven track record of leading cross-functional projects and managing clinical trial portfolios.
* Expertise in coordinating stakeholders for completion of clinical trials, including regulatory, operational, clinical, scientific, pharmacovigilance, monitoring, bioanalytics, manufacturing, laboratory, Qualified Persons, and others.