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Clinical Monitoring Resource Manager, Home-Based - IQVIA Biotech

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Primary Location: Morrisville, North Carolina, United States Additonal Locations: Dallas, TX,USA; New York, NY,USA; San Diego, CA,USA Full time R1213079

Job description

Help create a healthier world. START RIGHT HERE AT IQVIA.

This role will be a mix of resource management as well as Clinical Trial Manager responsibilities so individual needs to be flexible to manage both studies from a clinical operations perspective and take on resourcing.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

Responsible for all activities related to implementation and execution of clinical studies that include:

Clinical Resourcing Responsibilities:

  • Schedule and chair weekly resourcing meetings as well as ad hoc meetings to meet urgent business needs

  • Define current levels of spare capacity within Clinical Monitoring

  • Define and build a picture of current and short term future needs across the various resource types and geographical locations

  • Determine short to medium term hiring needs for Canada, United States and Latin America

  • Rationalize CRA deployment to optimize permanent:contractor ratio to contribute to the department financial priorities

  • Optimize the FTE projection process with regard to CRA allocations by study

  • Work with Clinical Monitoring team, Clinical Strategy team and Therapy Area leaders to identify staffing solutions by project, based on budget allocation

Client Duties/Responsibilities:

  • Work with Project Manager (PM) to define program targets for clinical monitoring staff and assure work is documented within contracted project scope. Communicate and document all interactions with client as required by SOP.

  • Serve as client advocate within IQVIA Biotech.

  • Develop and implement Clinical Monitoring Plan.

Team Duties/Responsibilities:

Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes, including:

Coordinate site management activities:

  • Site identification, recruitment, and selection. 

  • Regulatory document collection and review.

  • Overall scheduling and management of all site visits.

  • Develop site/monitoring tools and training materials.

  • Review and identify trends in enrollment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions.

Coordinate and oversee daily operations of clinical monitoring team:

  • Set and enforce project timelines with the assigned study team. 

  • Coordinate remote review of clinical data within EDC system.

  • Oversee monitoring visit schedule to ensure compliance with frequency set forth in contract.

  • Review and approve trip reports and follow-up letters within required timeframe.

  • Schedule and manage weekly CRA project team meetings.

  • Ensure CRAs assigned to team receive therapeutic and project-specific training.

  • Manage quality and regulatory compliance among clinical monitoring team and investigational sites.

Manage project milestones and proactively address deficiencies:

  • Attend and provide information at monthly projections meetings.

  • Attend and provide information at weekly client teleconferences/team meetings.

  • Assist Project Manager in identifying Out of Scope activities and assuring that such activities do not begin until the client provides authorization.

Manage CRA performance:

  • Define and implement functional standards, goals, and expectations with clinical monitoring team.

  • Serve as CRA mentor and perform accompanied field assessment visits as required.

  • Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of each respective CRA.

Documentation Duties/Responsibilities:

  • Assure that the appropriate IQVIA Biotech and/or sponsor SOPs are followed.

  • Ensure all project documentation is appropriately filed per IQVIA Biotech SOPs.

  • Assist PM in preparation of audit responses, as appropriate.

  • Assist PM with preparation of information for inclusion in monthly report to client.

Budget/Contract Duties/Responsibilities:

  • Assist PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions.

  • Define the scope of work with the client and clinical monitoring team.

  • Assist PM in identifying and generating changes in scope and notify client of potential changes in scope.

  • Review and approve CRA travel expenses and time sheets.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.

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