Overview:Patient & Site Engagement (PSE) Operations Specialist (OS) services provide the PSE Managers with administrative support for the management, execution and timely delivery of tactics for patient and site-facing initiatives in support of a clinical trial. Interface with key Delivery Unit customers Trial Delivery Leaders (TDLs), Trial Delivery Managers (TDMs). Interface with key Global Clinical Operations (GCO) customers Local Trial Manager (LTM) and Site Manager (SM), suppliers, and other stakeholders involved in the development, management, and dissemination of patient and site-facing tactics.
Responsibilities:- Services rendered will adhere to applicable sponsor SOPs, WIs, policies, local regulatory requirements, etc.
- Comply with relevant time reporting systems, training requirements and developing therapeutic knowledge enough for role and responsibilities.
- Ensure accuracy and oversight of Scope of Work (SOW) to reflect all External Service Providers planned services and budgets. This includes forecasting and proactive management of PSE trial budgets and Purchase Orders.
- Keep the project plan updated in relation to timelines and budget based on the scope of work for delivery of the tools and tactics for a clinical trial.
- Drive execution of tactics and initiatives through management of service providers as required by business including: creative and content development, global translations, material production, technical development of apps, websites, and other technological tools to promote patient/caregiver and/or site engagement.
- Ensure compliance with sponsor policies by way of documenting Compliance review and approval of tools and tactics; maintain oversight for IRB/EC approvals, as needed.
- Ensure clear communications with all stakeholders throughout the process to ensure clearly defined expectations. Stakeholders include service providers, study and clinical teams, PSE team members, leadership, and compliance. Contribute to study meetings via facilitation, attending, and/or presenting at various meetings.
- Maintain deep understanding and use of sponsor finance and contracting systems.
- Support the coordination of congress / conference preparations and on-site logistics, as applicable
- Ensure development and delivery of presentations and workshop content at Global Investigator Meetings, Ad Hoc face-to-face meetings, and other similar meetings as needed
Education and Experience Requirements: - BA/BS or equivalent, preferably in a scientific or health-related discipline.
- Minimum of 3 years relevant experience in global patient recruitment and clinical trial execution with a pharmaceutical company, CRO, and/or healthcare facility/research site.
- Strong clinical project management experience preferred
- Expertise in the areas of drug development, clinical trial operations, and strategic planning.
- Previous experience in clinical trial operations including the execution of study outreach, patient compliance and support programs.
- Strong planning and tracking skills, customer focused, well organized, detail oriented and capable of successfully managing multiple projects.
- Excellent time, priority, and self-management skills. Strong project management skills.
- Strong team orientation: demonstrates initiative to solve problems and improve efficiency and/or customer service.
- High degree of proficiency in Microsoft Excel, PowerPoint and Word. Microsoft Project.
- Good written and oral communication skills.
- Strong understanding of appropriate software and company systems.
- Periodic travel as required
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
The potential base pay range for this role, when annualized, is $62,800.00 - $157,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
