Clinical Operations Lead

The Clinical Operations Lead provides leadership of the operations team, in support of the project leader, and in collaboration with the other functional teams, to achieve the delivery of the project’s overall objectives to the Sponsor’s satisfaction per contract while optimizing speed, quality and cost of delivery and in accordance with our Standard Operating Procedures (SOPs), policies and practices.

Essential Functions:

• Oversee the delivery of Site Management project tasks, providing advice and guidance to help achieve high performance and quality project deliverables.

• Develop, implement and maintain the Site Recruitment, SPS Operations and SPS Risk Management Plans within the agreed project strategy.

• Ensure overall project efficiency and adherence to project timelines and financial goals; report metrics and out of scope activities.

• Manage and follow study activities through ongoing tracking and review of study progress. Provide input and report progress to appropriate SPS management and project management leaders.

• Act as the first line of escalation for site management questions and issues for assigned projects.

• Conduct co-monitoring and/or assessment visits to ensure the study is being conducted in accordance with the protocol, SOPs, GCP and applicable regulatory requirements.

• May participate in business development activities such as proposal development and bid defenses.

Requirements:

• Bachelor Degree preferably in a life sciences discipline, and 4 years of monitoring experience, team leadership experience; or equivalent combination of education, training and experience.

• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

• Skill in understanding and executing complex study designs.

• Strong written and verbal communication skills including good command of English language.

• Demonstrated team leadership and mentoring skills.

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 – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com