Patient Site Engagement Operations Specialist

IQVIA•Durham, NC

About The Position

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 Plans and organizes high level congress events, which includes, but is not limited to researching and hiring vendors, aligning agendas, booking venues, planning transportation, inviting participants, planning activities, creating event materials and creating name badges/signage. Meets with leaders and executives as necessary to discuss and plan event specifications such as scope, format, budget, administrative details, and special requirements. 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

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.
Experience managing a high volume of projects, events and vendors.
Experience supporting events of varying sizes at any one time.
Experience working with all levels of management, including a strong focus on working with executive level leadership.
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.
Periodic travel for conference and meetings as required

Nice To Haves

Previous experience supporting the planning, execution (including presentations), documentation, and close out of Investigator meetings is a plus.

Responsibilities

Provide 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.
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.
Forecast and proactively manage 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
Plans and organizes high level congress events, which includes, but is not limited to researching and hiring vendors, aligning agendas, booking venues, planning transportation, inviting participants, planning activities, creating event materials and creating name badges/signage.
Meets with leaders and executives as necessary to discuss and plan event specifications such as scope, format, budget, administrative details, and special requirements.
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