Clinical Data Strategy Implementation Lead

This role acts as a consultant for documenting data sources and identifying data needs in processes related to clinical trial conduct, including data definition and flow from source to reporting. The lead is responsible for driving specific work packages to implement the data strategy and systems roadmap."

Responsibilities

• Implement governance principles (goals, objectives, priorities, scope) for all clinical trial-related activities, ensuring alignment with the application portfolio and data standards.

• Partner with stakeholders across different R&D functions to identify opportunities for leveraging data and application capabilities to drive business decisions and optimize processes.

• Identify and document data needs for various processes, defining the system context in which these data needs will be utilized (e.g., Safety system, regulatory frameworks, CTMS).

• Identify primary transactional systems for specific data collection and creation, ensuring clarity on the roles of master systems, repositories, and central reporting.

• Assess system interconnection needs, including prioritization, and establish relevant standards (e.g., naming conventions, lists of values) and sources of reference for data points.

• Support the creation and documentation of data standards across the process landscape, aligning with the Clinical Trial Sourcing Data Strategy.

• Lead the development and implementation of clinical trial innovation strategies and extended data capabilities (machine learning, applied AI, data science, data engineering, BI, strategic analytics), guiding application architecture for compatibility

Needed Skills / Experience

• 10 years of experience in drug development including familiarity with respective processes. data and core transactional systems
• Experience in DDF (USDM), CDISC, or other public data standards.
• Ability to influence: This skill is important for engaging stakeholders and driving necessary changes within the organization.
• Background in data with deep understanding of issues in multiple areas such as data acquisition and processing, data management, distributed processing, and high availability.
• Ability to manage and oversee multiple workstreams simultaneously.
• Familiarity with relevant operational data, applications, and systems used in the pharmaceutical industry.
• Strong communication skills
• Strategic thinking
• Analytical skills

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