Clinical Program Manager
We are seeking a Clinical Program Manager to join our team in Dublin on a permanent basis. As Clinical Program Manager, you will be responsible for planning, developing, and managing Clinical Operations activities.
Key Responsibilities
* Oversee clinical project and site management activities including trial timelines, resources, and vendors.
* Lead the development of clinical trial protocols; participate in the development of the overall clinical plan, draft protocols, collaborate on statistical analysis plans, and coordinate the protocol review and approval process.
* Participate in identifying potential investigators and clinical sites, nationally and internationally; conduct pre-study site visits, collect and review data, and prepare evaluative reports.
* Assist in selecting contract research organizations and centralized services such as clinical laboratories; assess qualifications and experience in relation to proposed research activities.
* Manage research technical and/or trial administrative staff, including hiring, training, goal-setting, and distribution of workload.
* Develop clearly defined strategies 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.
* Therapeutic experience in infectious diseases, diabetes, or oncology.
* Familiarity with clinical research concepts, practices, and EMA/FDA regulations and ICH Guidelines.
* Ability to travel nationally and internationally as required.
* Experience managing a clinical trial portfolio and leading cross-functional projects.
* Expert knowledge in coordinating key stakeholders required for completion of clinical trials.