Assoc. Clinical Operations Lead, Real World Evidence
Assoc. Clinical Operations Lead
TheAssoc.COL lead the execution of the Site & Patient Services (SPS) components of Real World Late Phase Research (RLWPR) studies by applying clinical research expertise, exceptional decision-making skills and innovative approaches to problem solving. Proactively set project goals and tangible expectations for SPS project team members
- 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, 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
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