Job Description

• Serves as an in-house Centralized Trial Lead responsible for site management, data review, and/or query resolution management on assigned sites. Collaborates with (field) CRAs on assigned sites. Serves as IQVIA Biotech\xe2\x80\x99s in-house expert on assigned sites (for example, patient enrollment, eCRF completion, protocol compliance, study site staff issues, IRB and regulatory document status, data status, and other site metrics).
• Mentors and provides guidance and training to CSAs as necessary. Displays leadership regarding CSA initiatives and activities.
• Serves as a primary contact between IQVIA Biotech and the investigative site on assigned sites and ensures proper documentation of site management communications. Serves as back-up to assigned (field) CRAs and/or CSAs.
• In collaboration with the assigned (field) CRA, performs routine site management activities, including site training, assistance with site questions, patient recruitment and retention management, study supplies management, and other activities needed to ensure that assigned sites are conducting the study(ies) as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
• Collaborates with assigned (field) CRAs to resolve and document outstanding site issues/action items.
• Reviews the quality and integrity of patient data at assigned sites through the in-house (remote) review of electronic CRF data. Ensures timely transmission of clinical data from assigned study sites, and works with sites to resolve data queries.
• Assists with final data review and query resolution through database lock; inclusive of patient profile and data listings review.
• Helps ensures timely and appropriate site payments and updates CTMS as required to ensure proper timing and amount of payments.
• Assists with the development of the Integrated/Clinical Data Review Plan for assigned studies.
• Assists with the development of patient profile and data listings for review during data cleaning activities.
• Performs study evaluation, initiation, remote monitoring, and close out visits via WebEx or teleconference as appropriate. May monitor and/or co-monitor at sites when needed (travel

25%).

• May assist in the creation of Risk-Based Quality Management process and documentation plans for data surveillance analyses. Ensure that risk\xe2\x80\x93based quality trial management processes are performed to identify, assess, control, communicate and review study risk. This data surveillance is performed at specified intervals and throughout the duration of the trial per the study plan.
• Assists with the development of risk assessment thresholds and recommended actions for Key Performance Indicators (KPIs) for a study or program
• Makes recommendations about adjustments to KPIs and data analytics reviewed to ensure output continues to be appropriate (e.g. discontinue an analytic; adjust an analytic threshold/trigger).
• Designs data analytics to assess risk and works with appropriate functional department/vendor to program the designed reports.
• Assists with and attends (as needed) Investigator Meetings on assigned studies.
• Authorized to request site audits for reasons of validity.
• Performs other duties as requested by Management.
• May serves as back-up for CDRC, CTM/CTM/Sr. CTM to assist with project management tasks as needed.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible \xe2\x80\x93 to help our customers create a healthier world. Learn more at

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