Cancer Trials Ireland
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Associate Project Manager (APM) – Radiotherapy Studies
Location:
Dublin, Co. Dublin
Description:
Science and/or medical or Radiation Therapist or nursing background.Previous Medical or Clinical Research experience. Oncology an advantage.Proven ability to deliver project goals and mentor junior level employees.Knowledge of the Irish Clinical Trials environment.Experience with Clinical Trial set-up an advantage.Excellent communication skills, with the ability to represent the organisation at a national level Main Function(s) Maintain knowledge and ensure conduct of assigned studies is in compliance with ICH-GCP, regulatory and ethical requirements, applicable guidelines (including data protection), Standard Operating Procedures (SOPs), study protocols and project-specific procedures.Leadership and coordination of clinical trial activities for assigned studies.Develop and maintain strong working relationships with external Stakeholders/Sponsors. Primary Responsibilities Manage and coordinate assigned collaborative group RT/RT-IMP studies, including review, assessment and management of sites, vendors, study-specific / patient documents, development/review and assessment of country specific documents ensuring compliance with ICH-GCP, local regulatory and ethical requirements.Oversee/complete regulatory and ethic committee applications where required.Primary contact for Sponsor and collaborator groups for assigned studies.Provide expertise and feedback to Sponsors and collaborator groups on the regulations and requirements within the assigned countries.Share knowledge of country and site-specific processes during the start-up of a trial and throughout, to ensure compliance to the protocol can be maintained.Manage project-specific training and mentoring of junior staff members as assigned.Contribute to preparation for audits and inspections as required.Overall responsibility for management of essential documents, study files and Trial Master File where applicable.Pre-emptively identify potential issues and proactively manage resolutions and put in place, where possible, measures to minimise issues and risk for assigned studies.Ensure compliance with all applicable Cancer Trials Ireland and/or other Sponsor SOPs if applicable for all assigned studies.Contribute to departmental and cross-functional SOP development and updates as required.Organise, participate in, and present at meetings and discussions with other teams and team members.Draft and finalise budgets, contracts, and roles and responsibilities prior to commencing study activities, and manage throughout the lifecycle of the study.Update HCO, COO, and Operations Lead where applicable for assigned studies on the status of all clinical trial activities.Prepare study reports and other scientific documents as required.Perform other tasks as specified by Line Manager and as required for the study (e.g. conducting on-site initiation / close-out visits).
Company:
Cancer Trials Ireland
Posted:
June 26 on HireLocker
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More About this Listing: Associate Project Manager (APM) – Radiotherapy Studies
Associate Project Manager (APM) – Radiotherapy Studies is a Executive Project Manager Job at Cancer Trials Ireland located in Dublin D. Find other listings like Associate Project Manager (APM) – Radiotherapy Studies by searching Oodle for Executive Project Manager Jobs.
Associate Project Manager (APM) – Radiotherapy Studies is a Executive Project Manager Job at Cancer Trials Ireland located in Dublin D. Find other listings like Associate Project Manager (APM) – Radiotherapy Studies by searching Oodle for Executive Project Manager Jobs.