Operations Manager- Clinical Trials

Pe Global

Cork

PE Global are currently recruiting for a Clinical Trials Operations Manager for one of their pharmaceutical clients in Cork. This is a permanent role. Responsibilities of the role: Lead and manage the daily operation of the clinical trial capabilities team in support of clinical development. Accountable for ensuring accurate planning, prioritization across teams and timely execution working closely with site engagement at the affiliates and across the trial capabilities teams. The scope of the work includes activities related to investigator sites readiness; maintenance and close out ensuring country specific requirements are met. The manager is responsible for ensuring inspection readiness through a complete, accurate and readily available Trial Master File. Accountable for meeting and exceeding goals for clinical trial operations for development programs. Manage communications/relationships and serve as the point of contact for the trial capabilities team deliverables during site initiation, maintenance, and close out representing progress to business partners. Accountable for daily prioritisation of work to meet business needs. Provides expertise in conducting clinical research and keeping up to date with country/regional regulatory requirements. Develop and streamline processes ensuring efficiency and improved productivity as well as meeting customer requirements. Ensure inspection readiness through a complete, accurate and readily available Trial Master File. Identify and ensure shared learning across the clinical capabilities organization and with other functional groups within the CDO. Build capabilities in the function through the development and improvement of processes, tools and training. Enable a culture of continuous improvement to drive efficiency through process improvement, people skills, and shared learning. Recruit, develop, and retain a scientific and operationally capable workforce skilled and knowledgeable in clinical development. Effectively manage an agile organization that continuously meets the needs of a changing portfolio. Develop an organizational culture that fosters inclusion and innovation and demonstrates judgment based decision making in clinical delivery. Education and experience required: Bachelor’s degree preferably in a scientific or health related field, two years clinical research experience or relevant experience preferred. Understanding of the overall clinical development model and the importance of efficient site initiation. Previous supervisory experience. Strong leadership skills and ability to influence others and lead across the business. Project management processes and skills. Ability to learn and comply with financial and legal guidelines and policies (budget and contract. Language capabilities preferred. If you are interested in this position, please forward your CV to catherine.osullivan@peglobal.net or call Catherine on 0214297900. This job originally appeared on RecruitIreland.com.

2225 days ago