Site Augmentation Lead

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.

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Be responsible for the day-to-day oversight and close out of allocated Site Augmentation 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.

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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.

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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

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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.

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Deliver Site Augmentation 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.

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Ensure that assigned projects centrally stored trackers are complete and up to date always, to ensure appropriate business continuity measures are met.

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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.

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Builds differentiating and sustainable relationships with the Site community, where Illingworth’s services are available to them across all of Illingworth’s service lines.

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Oversees performance and issue management of studies running within Site Augmentation and through supporting the Site Contracts manager to extend the relationships across all Illingworth service lines.

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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.

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Collaborates with study team to define and lead the site engagement and contracting processes through the conducting of site-specific detailed needs assessments that will guide the type of Site solutions resource deployed to the site in compliance with local due diligence and regulatory requirements.

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Responsible for leading Site Augmentation related resource management in collaboration with the Talent Acquisition and Resource management teams, for studies including, but not limited to:

• Requesting site level resources to support projects, ensuring that the recruitment, allocation & onboarding of Site Augmentation resource is completed in line with the project's defined deployment strategy.
• Communicating changes to resource requirements (change in scope)
• Provide oversight to team of site solutions resources for the implementation of their site augmentation deployment activities, including onboarding and training for the project.

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Acts as the Company champion for site and sponsor clients both internally and externally.

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Supports the delivery and implementation of specific Site Augmentation initiatives aligning to Illingworth and Syneos business needs. Continues to build awareness internally of the relationship and working practices between site and sponsor stakeholders and the Company.

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Supports the development & maintenance of relevant information libraries and communication materials to assist with RFI/RFP development and queries from Sponsors, Business Development, and project teams.

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Ensures all project deliverables meet customer expectations including contracted deliverables, provision of accurate projections, reports and updates, together with ongoing risk assessment and proactive mitigation strategies. Completes and documents scope changes.

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Ability to understand and translate protocol requirements to deliver the proposed site solution, in collaboration with Sponsor and key cross-functional leads.

Additional Information:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Originally posted on Himalayas