The services hold a responsibility for implementation and maintenance of digital health systems supporting clinical development activities within the Global Development department. The incumbent will be required to provide subject matter expertise in system implementation, validation, maintenance and issue escalation. In addition, it includes participation in/lead operational strategy projects.

The services require to work closely with other team members to ensure system impact is assessed and mitigation strategies are in place where applicable. A clear understanding on the needs of clinical trials/programs and internal or external stakeholders.

• Lead projects and/or workstreams actively engaging team members from start to closure
• Use project management tools for lean execution of a project
• Analyze and document complex client business requirements and processes; communicate these requirements to appropriate parties
• Continuously evaluate roadmap of each technology/vendor to align with the existing/future landscape and adjust/escalate where needed
• Interact with other application team leads which have interfaces with our DH applications

EDUCATION & EXPERIENCE

• At least 6 years of experience within a pharmaceutical company or a CRO is required.
• Strong understanding of Digital Health capabilities and their application in clinical trials.
• Excellent collaboration and communication skills, with the ability to work effectively with business stakeholders.
• Experience in supporting governance frameworks and audit processes.
• Ability to identify and drive efficiency improvements in Digital Health initiatives
• Seasoned with various testing tools.
• Experience in developing use cases, user interface specifications and user requirement specification documents.
• Proven experience in implementing SAAS technologies within clinical trial operations.
• Demonstrated knowledge of clinical development processes, global clinical operations, and strategic planning is required.
• Demonstrated knowledge of industry best practices for vendor management is required.
• Flourish in a fast-paced environment requiring excellent problem-solving skills, multiple project completion under short deadlines, decision-making, presentation skills and the ability to communicate with clients and end users
• Ability to quickly understand complex systems and be able to explain them to varying customers
  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.co

System Support

• Follow-up and support releases for the technologies/systems in use
• User acceptance testing to be performed for each respective technology/vendor systems in use
• Identify/write system test scripts with the highest quality
• Review of System Development Lifecycle (SDLC) documentation, as applicable
• Evaluate Change Control Plan/Report as appropriate in close collaboration with IT
• Support system UAT automation where needed
• Work with IT to re-test defects after a fix has been applied, including regression testing
• Support integrations landscape and validation needs
• Support vendor oversight, which can include incident/problem management, device provisioning follow-up and escalate as needed.

System Operational Strategy

• Participate in strategy projects implementing new solutions
• Ensure implementation follows the landscape strategy
• Create and review documentation requirements
• Interact with key internal and/or external stakeholders
• Align and support system requirements
• Interact with Business and obtain the Business Scenarios.

General

• Services rendered will adhere to applicable Client SOPs, WIs, policies, all applicable local laws and regulations, ICH-GCP, etc.
• Comply with relevant training requirements.
• Protect the rights of others; protect privacy and company assets, particularly information as the key asset.
• Maintain adequate communication with relevant parties within and outside the company
• Regularly update information in applicable systems and templates.
• Contribute to the development and improvement of departmental procedures, processes and templates in the scope of the company’s effort towards continuous quality improvement.
• Maintain quality standards and timelines that are consistent with business needs.
• Organize multiple complex priorities and projects and use a range of techniques to identify and resolve trial-related problems
• Change management – understand how to cope with change and influence/motivate others to deal with change
• Act as DHE Liaison with named DUs to establish strong cross-functional relationships and enable early visibility of long-term DH portfolio requirements
• Act as Business and/or Technical Owner for DH developed tools/systems