Clinical Program Manager
Our Dublin based client is currently recruiting for a Clinical Program Manager to join their team on a permanent basis. As Clinical Program Manager, you will be responsible for the planning, development, and management of Clinical Operations activities.
Responsibilities
* Oversee clinical project and site management activities including trial timelines, budgets, 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, including submissions to regulatory agencies.
* Participate in the identification of potential investigators and clinical sites, both nationally and internationally; conduct pre-study site visits, collect and review data, and prepare evaluative reports; participate in the final selection of investigators and study sites.
* Assist in the identification of contract research organizations and centralized services such as clinical laboratories; assess qualifications and experience in relation to proposed research activities, and participate in final selection and contract negotiation.
* Oversee 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, cross-functional interdisciplinary, high-priority initiatives and process improvements.
Requirements
* Bachelor’s 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 a plus.
* Therapeutic experience in infectious diseases, diabetes, or oncology.
* Must have a thorough knowledge of clinical research concepts, practices, and EMA/FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and data management methods.
* Must be open to national and international travel as and when the job requires.
* Experience managing a clinical trial portfolio and able to demonstrate a proven track record of successfully leading cross-functional projects.
* Expert knowledge in coordinating key stakeholders required for completion of clinical trials including regulatory, operational, clinical, scientific, pharmacovigilance, monitoring, bioanalytics, manufacturing, laboratory, Qualified Persons, and others.
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