Clinical Data Strategist

IQVIA•Durham, NC

3d•$86,500 - $216,000

About The Position

Performs and oversees the set-up of individual systems (EDC, IRT etc), ensuring data standards are followed leading to successful data integration with the Data Factory (DF)/Clinical Data Repository (CDR). Ensure the data collected and integrated into the Data Factory (DF)/Clinical Data Repository (CDR), can be successfully utilized in all downstream systems by First Patient In (FPI).

Requirements

Experience working in Drug Discovery, clinical trial conduct, clinical data management or related industries.
Excellent critical thinking and analytical skills, strong attention to detail
Effective written, interpersonal, and verbal communication skills
Strong influencing, problem resolution, motivation, and negotiation skills
Solution-oriented approach to challenges
Sound leadership and customer service skills
Competent presentation skills meeting the needs of all levels
Ability to establish and maintain effective working relationships with team members, management, operations staff, clients, and executive management
Ability to lead effective meetings
Strong organizational and time management skills
Ability to manage multiple dependencies across multiple systems to reach a final deliverable
Ability to establish and maintain effective working relationships with teams involved in study start up
Bachelor in Science/Computer Science/Information Technology or Bachelor in Technology with 8 to 10 years experience OR equivalent combination of education and experience.
7+ years of CRO experience with knowledge of clinical systems, the data points stored within them and data flow paths.

Responsibilities

Work directly with project teams to guide/convey optimal data flow design patterns across the enterprise consisting of multiple systems with the end goal to ensure data integrations enable real time Alerts and Analytics
Lead vendor data set-up for Data Management vendors and other functions as required, enabling the data flow for downstream activities (data cleaning, etc).
Complete and manage the 'Systems Integration Plan' to detail the data flow and highlight potential risks/challenges while collaborating with various groups (i.e. IPA, Study Team, CDAT) to provide data standardization and alignment of site visits across systems”.
Champion people, process and technology improvements and standards to enhance quality, increase productivity (internal and external with Investigator sites) and reduce data latency within Quintiles clinical trial systems inclusive of IVxS, EDC, CTMS, QRPM, Data Factory, Triggers and Alerts, Visualizations such as Clinical Analytics and Federated reports, CDOS and SLDRs.
Guide and present study teams with best case options given limitations (e.g. contract, cost, timelines, etc.) with the ability to articulate pros and cons of each approach.
Identify and implement innovative solutions to challenges and influence future decision-making in order to reduce workarounds.
Review data transfers specifications to ensure they meet the standards required to develop quality data integrations.
Proactively provide education and training to ensure adherence of the relevant startup SOPs and best practices during the RFI and post-award phases.
Collaborate with the global IT organization as needed to resolve support issues related to data integration or data quality.
Ability holistically understands the process and structure of 5-10 individual systems and determine how the design of one system may impact the ability of another system to function optimally.