Clinical Operations Team Lead

Job Overview

Manage a team of clinical research technicians.  Assist with study procedures as needed.

Essential Functions
• Ensure compliance with staff training requirements by auditing and maintaining training records
• Assess assigned studies for potential risks and perform risk mitigation
• Oversee preceptor & training program for new and junior staff. Design, implement, monitor, and assess the need for training programs to maintain staff skill proficiency.
• Supervise and coordinate department activities to ensure that studies are carried out according to protocol, standard operating procedures (SOPs) and applicable guidelines and regulations and within budget
• Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work
• appraising performance and guiding professional development
• rewarding and discipling employees
• addressing employee relations issues and resolving problems
• approve actions on human resources matters
• Ensure appropriate staffing levels
• develop plan for use of available resources
• coordinate resources use when changes occur and subject issues arise. Ensure availability and proper maintenance of required equipment and facilities
• May participate in review of proposals and protocols providing advice on clinical feasibility and cost
• Create and implement SOPs and training programs with an emphasis on quality and safety
• May Troubleshoot issues on study
• May lead huddles to ensure daily tasks are assigned to team members and are executed to the expected standards
• May assist with data quality checking and query resolution
• May Collect, record, and maintain volunteer study data according to study-specific protocol and SOPs ensuring quality control for content, accuracy, and completeness
• May instruct subjects how to perform at-home procedures according to the protocol and other training documents
• May perform a variety of complex clinical procedures that may include but not be limited to electrocardiograms, blood and urine sample collection, vital signs and IV cannulation
• May Monitor subject safety and report adverse reactions to appropriate medical personnel
• May Recruit and screen subjects for trials
• Participate in quality and process improvement efforts to support the culture towards a high-performing and efficient team. Identify lessons learned and implement best practices.
• May create source documents to capture protocol-required data
• May manage source documents per GCP
• May collect and review source data on CRF and eCRF
• May lead study team meetings
• May hold Basic Life Support (BLS) instructor certification and facilitate BLS classes

Qualifications

• Have at least 1 year of line management experience OR at least 3 years of clinical research experience OR equivalent combination of experience.
• Strong written and verbal communication skills including good command of the English language.
• Good skill in using MS Windows/Office applications such as Outlook and Word.
• Excellent interpersonal skills.
• Excellent customer service skills.
• Ability to pay close attention to detail.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• In-depth knowledge of clinical trials.
• In-depth knowledge of Good Clinical Practices (GCP).
• Excellent problem-solving skills.
• Effective organizational skills.
• Strong time management skills.

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.