Clinical Operations Lead

• Oversee the delivery of Site Management project tasks, providing advice and guidance to achieve high performance and quality project deliverables.
• Ensure overall project efficiency and adherence to project timelines and financial goals; report metrics and out of scope activities.
• Develop, implement and maintain the Site Recruitment, SPS Operations and SPS Risk Management Plan within the agreed project strategy.
• Collaborate with other functional groups within the company such as data management, quality assurance and biostatistics where necessary to support milestone achievement and to manage study issues and obstacles.
• 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 on assigned projects.
• Lead preparation for in-house audits and in creation of Corrective Action Plans (CAPAs).
• Develop and deliver presentations/training to clients, colleagues and professional bodies, as required.

• Bachelor Degree preferably in a life sciences discipline, and 4 years of monitoring experience, project leadership experience; or equivalent combination of education, training and experience.
• Previous experience as Clinical Trial Manager and SSU.
• 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