Site Augmentation Lead at Syneos Health in SRB-Belgrade

Job description

Site Augmentation Lead Illingworth Research Group provides a range of patient focused clinical services to the pharmaceutical, healthcare, biotechnology and medical device industries. These include mobile research nursing, patient concierge, medical photography and clinical research services. Illingworth are experts with experience across all study phases and in a diverse range of therapeutic areas. Illingworth Research Group is a global organization operating in over 45 countries, bringing clinical research directly into the home of the patient, to improve the experience of patients involved in clinical trials and the quality of their lives. Job Responsibilities For allocated projects, upon handover from the Illingworth BD, Proposals or Strategy lead be the Primary point of contact for both sponsor clients & sites and Illingworth business units and functions, liaising with the AD SS and Director SO&E for issue management and resolution for all Site solutions projects. • Be responsible for the day-to-day oversight and close out of allocated Site Solutions projects and to liaise with the Resource management team, Finance, and IT (Information Technology), delivering the project until completion in accordance with the appropriate clinical SOPs (Standard Operating Procedures), GCP (Good Clinical Practice) and all applicable regulatory requirements. • Ensure project specific training requirements are agreed with the Sponsor and Sites, including the roles and responsibilities for delivery of this training to the allocated Illingworth site resource to be deployed. Where responsibility falls to the Illingworth team for delivery, ensuring that this is managed as per the relevant SOPs and Policies. • Oversee and lead the development, review and finalization of project-related documentation whilst ensuring the processes and procedures within the documents comply with relevant policies, Standard Operating Procedures (SOPs), ICH-GCP, and all applicable country regulatory requirements, in collaboration with the client and, where applicable, sites • Develop a clear understanding of the study budget and its scope, managing it to the point of completion and reconciliation. Prepare accurate financial and activity forecasts for the lifetime of the project and report actual performance against forecast. Prepare monthly invoices based on project activity. Identify changes in scope and seek client approval for change orders. • Deliver Site Solutions projects through good communication, clear implementation plans and explicit performance metrics to agreed timelines and quality, across the project life cycle. Provides input to corrective and preventive action associated with quality issue resolution. Communicates compliance and performance to relevant stakeholders including other Illingworth business units, clients (Sponsor & CRO), clinical trial sites and vendors to ensure excellent relationships continue and all parties are kept up to date with project progress. • Ensure that assigned projects centrally stored trackers are complete and up to date always, to ensure appropriate business continuity measures are met. • Supports the development of collaborative and effective site relationships and future horizon planning for Site solutions and optimization strategies. Is a resource for the broader Illingworth team related to site relationship management. • Builds differentiating and sustainable relationships with the Site community, where Illingworth’s services are available to them across all of Illingworth’s service lines. • Oversees performance and issue management of studies running within Site solutions and through supporting the Site Contracts manager to extend the relationships across all Illingworth service lines. • Leverages experience, knowledge, and best in class practices to drive global Site optimization and Engagement of all Illingworth service lines. Ensures alignment with broader Illingworth and Syneos goals and objectives. • Collaborate