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Role Overview:
The Site Enablement Solutions team at IQVIA provides qualified, clinically experienced research staff to clinical trial sites globally to accelerate and optimize the performance of clinical trials. By supplying sites with support for data entry, patient recruitment, patient visits, assessments, and other tasks, IQVIA is able to relieve the burden on trial sites and support our sponsors in completing their trials on time, and within budget.
The goal of the Site Enablement Solutions Project Lead (SES PL) role is to optimize overall delivery of Site Enablement Solutions throughout the lifecycle of projects. The SES PL will also serve as internal consultants to the IQVIA study team and/or sponsor, present progress, and updates to sponsor, and manage overall delivery of our services on a project, including managing the Site Enablement project budget.
Key Responsibilities
Collaborate with pre- and post-award stakeholders to manage the coordination, planning, and implementation of Site Enablement Solutions.
Develop global Site Enablement Solutions delivery strategy in identifying sites, executing on agreed upon scope and extending/expanding our services as warranted.
Determine internal team resourcing based on study needs.
Develop and execute operational plans on larger, multi- region studies or programs, including develop and implement risk management plans for minimizing impact on project objectives and deliverables. Establish study specific expectations and timelines.
Communicate with sponsors and project teams to implement and monitor impact of Site Enablement Solutions.
Provide ongoing proactive operational and tactical recommendations as needed based on study performance.
Collaborate with internal and external teams to deliver site adoption and quality resource placement within specified timelines.
Establish a collaborative approach for project delivery with Patient and Site Centric Solutions teams, including patient recruitment team and Direct to Patient Campaign.
Schedule and facilitate internal study meetings.
Represent Site Enablement Solutions at site/sponsor-facing meetings (i.e. KOM, IM, F2F/LL, etc.) to present strategy/rationale, and training.
Ownership for study KPI and financial performance. Manage the scope of work, objectives, quality of deliverables, and other activities of assigned projects.
Manage and oversee internal workflow management systems to ensure compliance.
Other duties as assigned by management.
Qualifications:
To perform the Site Enablement Solution Project Lead job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Knowledge of the drug development processes across all functional areas, Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines Project management skills, including issue, budget & timeline management; Excellent organizational and problem-solving skills Effective time management skills and ability to manage competing priorities. Strong interpersonal skills and effective presentation skills. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Computer skills including proficiency in aspects of data analysis and presentation software, Microsoft Word, and Excel. Strong written and verbal communication skills.
Education: Bachelors degree in life sciences or related field.
Experience requires 3 - 5 years of prior relevant experience.
5 years’ clinical trial experience
3 years’ experience at a CRO or clinical trial services provider
3 years’ Project management/functional lead experience
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IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
