Local Trial Manager - Home Based-Canada* full-time

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Overview We believe that our people are the future of the industry. We provide a culture in which our employees can enjoy personal satisfaction, professional achievement and have the ability to strategically map out long-term career plans. If you're ready to be a part of something inspiring join us and Discover Your PRA. Who are we? We Are PRA. We are 16,000+ employees strong, operating in more than 90+ countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most. Responsibilities What will you be doing? Working outsourced and fully dedicated to one of our global pharmaceutical clients, the Local Trial Manager is responsible for the successful management and execution of study activities at a country level. Collaborating with the wider global study team, the Local Trial Manager leads the local team of Site Managers and Clinical Trial Assistants in order to deliver quality data and trial documents that are compliant with the protocol, ICH-GCP guidelines, Standard Operating Procedures and regulatory requirements. Key tasks Include (but not limited to): Managing the local team to meet recruitment targets The efficient management of local vendors Timely review of trip reports submitted by Site Managers Targeted and effective study team training Preparation for audits Development of local study tools and procedures Proactive risk management and budget forecasting Accompanying Site Managers on on-site visits to ensure protocol compliance at a site level, and to foster positive working relationships with site staff, including Investigators. Some on-site monitoring of assigned sites Managing studies from feasibility through to database lock and close-out, the Local Trial Manager acts as the key local manager throughout the lifecycle of the project. Qualifications What will you be doing? Working outsourced and fully dedicated to one of our global pharmaceutical clients, the Local Trial Manager is responsible for the successful management and execution of study activities at a country level. Collaborating with the wider global study team, the Local Trial Manager leads the local team of Site Managers and Clinical Trial Assistants in order to deliver quality data and trial documents that are compliant with the protocol, ICH-GCP guidelines, Standard Operating Procedures and regulatory requirements. Key tasks Include (but not limited to): Managing the local team to meet recruitment targets The efficient management of local vendors Timely review of trip reports submitted by Site Managers Targeted and effective study team training Preparation for audits Development of local study tools and procedures Proactive risk management and budget forecasting Accompanying Site Managers on on-site visits to ensure protocol compliance at a site level, and to foster positive working relationships with site staff, including Investigators. Some on-site monitoring of assigned sites Managing studies from feasibility through to database lock and close-out, the Local Trial Manager acts as the key local manager throughout the lifecycle of the project. What do you need to have? Previous experience of managing a clinical study is an absolute requirement for this role. Previous experience of managing an internal team (including Clinical Research Associates and Clinical Trial Assistants) is highly preferred. Strong problem-solving skills, and independent proactive attitude to work, effective communication skills in English, and the ability to engage and motivate a team will ensure success within the Local Trial Manager role. A background in on-site monitoring is also necessary in order to be considered. Experience working on mega-trials or in risk-based monitoring is preferred. 3+ ye


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