Digital Health Operations Manager - Sponsor Dedicated

This service primarily leads the development of Digital Health Operations deliverables to meet the needs of the study/program and internal stakeholders. The service will be required to provide technical expertise in Digital Health development, specification development and provide subject matter expertise to cross functional study teams. The service will lead all Digital Health Operations related activities and will be the main point of contact for the cross-functional study team. This service is expected to maintain an awareness of industry benchmarks and evaluate innovative new technologies to ensure the Digital Health Center of Excellence (CoE) processes are at the ‘best practice’ level of performance.

Responsabilities

• Services rendered will adhere to applicable sponsor SOPs, WIs, policies, local regulatory requirements, etc.

• Provide advice/recommendation to study teams regarding supplier(s) and technology alternatives.

• Complete Requests for Proposal documentation and recommend appropriate suppliers to support study needs.

• Provide leadership and expertise for the completion of supplier specification development and set-up activities through the lifecycle of a trial.

• Lead the cross functional study team through changes of scope, providing technical expertise on the change of scope, assessment of risk, and oversight of system requirements updates.

• Serve as the point of contact specific to inspection readiness activities between the study team and the Digital Health technology suppliers.

• Effectively manage internal and external business partner relationships in support of R&D Operations’ deliverables.

• Monitor key performance indicators (KPIs) and metrics for services provided by suppliers.

• Conduct Lessons Learned sessions following the completion of study start-up activities and as necessary, throughout other phases of the clinical development process.

• Effectively support the study team in close-out/deactivation of the technology system.

Requirements

• Bachelor’s degree (University degree) or equivalent education / relevant experience required

• At least 3 years operational experience in clinical trials with a pharmaceutical company and/or a Clinical Research Organization is required

• Demonstrated knowledge of clinical development processes, global clinical operations, and strategic planning is required

• Familiarity with industry best practices for vendor management is required.

• Strong project management skills and presentation skills with the ability to lead a team independently is required

• Experience with Digital Health solutions, including ePRO, eCOA, and EDC platforms

• Strong knowledge of Clinical Operations and Clinical Development processes

• Sponsor-facing communication and stakeholder management experience

• Global study delivery experience

• Proven ability to lead implementation projects and manage external suppliers

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

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.