Director, Clinical Monitoring, Home-Based - IQVIA Biotech

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BASIC FUNCTIONS:

To provide strategic leadership, organization and training of the clinical trials monitoring group.  To assure growth of revenue and profitability through the provision of quality, client-oriented clinical monitoring services.  Assures compliance with (1) IQVIA Biotech standard operating procedures, (2) FDA guidelines, legislation, and procedures, (3) all applicable national and international regulations, and (4) Company and client monitoring plans and expectations. Work directly with the EVP, Clinical Operations, to grow the Clinical monitoring group to meet the needs of IQVIA Biotech through effective recruiting and hiring and enhancing skills of the staff.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Directs the performance of the clinical monitoring staff.  Develops monitoring timelines, develops strategic goals with staff, and provides guidance as needed for completion of tasks.  Assesses performance and recommends salary adjustments.

• Reviews and assist Clinical Trial Manager(s) with the development of monitoring plans in accordance with Good Clinical Practices (GCP) and assures compliance within the Clinical Monitoring Group.

• Designs, develops, and updates Standard Operating Procedures for all clinical monitoring functions.

• Develops budgets and is accountable for the profit/loss for the monitoring component of each project and the overall performance of the Monitoring Department.

• Develops budgets for the monitoring component of proposals in conjunction with VP, Clinical Operations.

• Assures that monitoring functions interface effectively with all other key operating departments within IQVIA Biotech.            

• Directs the process for the selection of study sites and investigators.

• Works with Human Resources and eReady Monitoring in recruiting and hiring qualified monitors to staff IQVIA Biotech projects.

• Develops strategies to meet patient recruitment expectations.

• Ensures training for the monitoring staff.  Selects training curriculum for the monitoring staff.

• Reviews and approves reports and manuscripts, as necessary.

• Maintains current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research.

• Participates in business development activities to grow IQVIA Biotech business

KNOWLEDGE, SKILLS AND ABILITIES:

• Demonstrated knowledge of electronic data management operations.

• Demonstrated knowledge of quality assurance related to clinical monitoring.

• Demonstrated ability to form strong working relationships across functional boundaries.

• Demonstrated ability to motivate, lead, and grow a monitoring team.

• Extensive demonstrated experience directing a monitoring staff.

• Extensive experience with monitoring and supervision according to Good Clinical Practices.

• Experience with pharmaceutical product development.

• Excellent knowledge of FDA and/or ICH guidelines for conducting clinical research.

• Excellent written and verbal communication skills.

• Exceptional ability to conceptualize, develop and manage timelines.

• Demonstrated knowledge of resources required to permit protocol implementation.

• Considerable ability to develop and maintain productive relationships with colleagues and other research organizations.

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

• Ability to travel domestically

• Very limited physical effort required to perform normal job duties

MINIMUM RECRUITMENT STANDARDS:

• BS in a health or life sciences-related field (i.e., nursing, pharmacy, pre-medicine, etc.) with at least five years of demonstrated clinical trials monitoring experience; or appropriate BA/BS Degree in life sciences (i.e., nursing, pharmacy, pre-medicine, etc.) equivalent combination of education, training and experience.

• Within the total years of experience, at least one (1) years of management experience in a contract clinical research position is required. 

• Pharmaceutical clinical research experience and electronic data management experience are required.  

• Excellent demonstrated knowledge of issues affecting data analysis for clinical trials are required.  Excellent written and verbal communication skills are required. 

CLASSIFICATION (US):

This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.

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.